e8vk
 
 
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): October 21, 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
  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))
 
 

 


 

Item 2.02   Results of Operations and Financial Condition.
     On October 21, 2008, Biogen Idec Inc. issued a press release announcing its results of operations and financial condition for the three months ended September 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.

 


 

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: October 21, 2008

 


 

EXHIBIT INDEX
         
Exhibit    
Number   Description
       
 
  99.1    
The Company’s press release dated October 21, 2008.

 

exv99w1
Exhibit 99.1
Page 1 Biogen Idec Reports Third Quarter 2008 Results
(BIOGEN IDEC 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) 679-2812
FOR IMMEDIATE RELEASE
Biogen Idec Reports Third Quarter 2008 Results
38% Revenue Growth
Cambridge, MA, October 21, 2008 — Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its third quarter 2008 results.
Third Quarter 2008 Highlights:
  Third quarter 2008 revenues were $1,093 million, an increase of 38% from $789 million in the third quarter of 2007, driven primarily by AVONEXÒ (interferon beta-1a) sales up 26% to $573 million, TYSABRIÒ (natalizumab) sales up 172% to $171 million, and RITUXANÒ (rituximab) revenues from the unconsolidated joint business arrangement up 27% to $299 million.
  On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), third quarter 2008 diluted earnings per share (EPS) were $0.70, an increase of 71% from $0.41 in the third quarter of 2007. GAAP net income for the third quarter 2008 was $207 million, an increase of 73% from $119 million in the third quarter of 2007.
  Third quarter 2008 non-GAAP diluted EPS were $0.98, an increase of 69% from $0.58 in the third quarter of 2007. Non-GAAP net income for the third quarter 2008 was $288 million, an increase of 69% from $170 million in the third 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 Third Quarter 2008 Results
  Global in-market net sales of TYSABRIÒ in the third quarter of 2008 were $236 million. Based on our collaboration structure with Elan Corporation, plc., Biogen Idec recognized revenue of $171 million related to TYSABRI in the third quarter of 2008.
“We continue to deliver exceptional financial performance as we grow sales of our three key products and advance our pipeline,” said James Mullen, Biogen Idec’s Chief Executive Officer. “For the first time in the company’s history, Biogen Idec reported quarterly revenues in excess of $1 billion. We increased revenues more than 25% and grew earnings by 30% for the fourth consecutive quarter. Our prospects for growth, both now and in the future, remain strong.”
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 third quarter of 2008. On a non-GAAP basis, Biogen Idec reported net income of $288 million in the third quarter of 2008. Non-GAAP diluted EPS were $0.98 for the third quarter of 2008.
A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As of September 30, 2008 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2 billion. In the third quarter we recorded a charge of $24 million, or $0.06 per share, in “other income, net” related to the impairment and realized losses of certain assets in the company’s investment portfolio.
Revenue Performance
Revenues from AVONEX, one of Biogen Idec’s therapies for patients with relapsing forms of multiple sclerosis (MS), increased 26% in the third quarter 2008 to $573 million, as compared to the third quarter of 2007. U.S. sales increased 21% to $322 million and international sales increased 33% to $252 million in the third quarter of 2008 as compared to the third quarter 2007.
Revenues for the third quarter of 2008 included $299 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 $655 million in the third quarter, as compared to $572 million in the third quarter of 2007.
During the third quarter of 2008, Biogen Idec recognized revenue of $171 million related to TYSABRI comprising:
  $56 million related to product sold through Elan in the U.S. (based on $122 million of in-market sales); and
  $115 million related to product sold by Biogen Idec, internationally.

 


 

Page 3 Biogen Idec Reports Third Quarter 2008 Results
As of the end of September 2008, more than 35,500 patients were on commercial and clinical TYSABRI therapy worldwide. According to data available as of the end of September 2008:
  In the U.S., more than 19,500 patients were on TYSABRI therapy commercially;
 
  Outside of the U.S., nearly 15,300 patients were on TYSABRI therapy commercially;
 
  In global clinical trials, more than 700 patients were on TYSABRI therapy; and
 
  There have been two 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 48,000 patients have been treated with TYSABRI; and
  Of those patients, nearly 18,000 have received at least one year of TYSABRI therapy and approximately 9,500 patients have been on therapy for 18 months or longer.
Revenues from other products were $14 million and $12 million in the third quarter of 2008 and 2007, respectively, consisting primarily of FUMADERMÒ (fumaric acid esters).
Table 4 provides individual product revenues.
Royalty revenues were $35 million and $24 million in the third quarter of 2008 and 2007, respectively.
Share Repurchase Program
There were no shares repurchased under our share repurchase program for the three months ended September 30, 2008.
Financial Guidance
Following its strong performance, Biogen Idec provided its 2008 financial guidance:
    Total revenue growth above the mid 20% range over 2007.
 
    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 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 above $2.51. Both Non-GAAP and GAAP diluted EPS include the potential for upfront and milestone payments of approximately $40 million which are under consideration for the fourth quarter.
 
    Capital expenditures of $270 to $290 million.

 


 

Page 4 Biogen Idec Reports Third Quarter 2008 Results
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.
Recent Highlights
    On October 6, 2008, Biogen Idec and Genentech announced that a global Phase III study of RITUXAN in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL) compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study. An independent review of the primary endpoint is being conducted for U.S. regulatory purposes.
 
    On September 18, 2008, Biogen Idec announced that data was presented from the ASSURANCE (ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs) study, showing the long-term benefits of AVONEX® therapy in patients with relapsing multiple sclerosis (MS) for up to 15 years. The ASSURANCE study represents the long-term follow-up of patients who participated in the Multiple Sclerosis Collaborative Research Group (MSCRG), the original Phase III pivotal trial from which AVONEX was approved.
 
    On September 5, 2008, Biogen Idec and Elan Corporation, plc announced the initiation of the first clinical trial of TYSABRI in oncology. The objectives of this Phase I/II study are to evaluate the safety and potential anti-tumor activity of TYSABRI in patients with relapsed or refractory multiple myeloma. TYSABRI is a recombinant, humanized monoclonal antibody that targets the adhesion molecule VLA4 (also known as alpha-4 integrin) that is expressed on the surface of many types of immune cells. VLA4 is also found on the surface of multiple myeloma cells and may be involved in their survival.
 
    On August 21, 2008, Biogen Idec announced the initiation of a Phase III clinical trial of intravenous (IV) ADENTRI® (BG9928), an adenosine A1 receptor antagonist, for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate ADENTRI, which is being developed under a licensing agreement with CV Therapeutics (Nasdaq: CVTX), or placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the United States.
Conference Call and Webcast
The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 21, 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 November 22, 2008.

 


 

Page 5 Biogen Idec Reports Third Quarter 2008 Results
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 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 significant investments in marketable securities, the impact of the global credit crisis, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, 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.
September 30, 2008
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2008     2007     2008     2007  
REVENUES
                               
Product
  $ 758,260     $ 529,581     $ 2,107,816     $ 1,532,594  
Unconsolidated joint business
    298,979       234,637       825,024       672,391  
Royalties
    35,162       23,537       87,258       69,172  
Corporate partner
    563       1,476       8,496       4,160  
 
                       
Total revenues
    1,092,964       789,231       3,028,594       2,278,317  
 
                       
COST AND EXPENSES
                               
Cost of sales
    107,493       81,613       300,828       247,626  
Research and development
    268,800       286,274       779,291       695,872  
Selling, general and administrative
    232,824       190,644       694,342       582,373  
Amortization of acquired intangible assets
    94,464       65,689       242,114       186,570  
Collaboration profit (loss) sharing
    43,533       5,842       98,368       170  
In-process research and development
          29,959       25,000       48,364  
 
                       
Total cost and expenses
    747,114       660,021       2,139,943       1,760,975  
 
                       
Income from operations
    345,850       129,210       888,651       517,342  
Other income (expense), net
    (24,725 )     44,904       (29,818 )     98,192  
 
                       
INCOME BEFORE INCOME TAXES
    321,125       174,114       858,833       615,534  
Income taxes
    114,337       54,733       282,320       178,512  
 
                       
NET INCOME
  $ 206,788     $ 119,381     $ 576,513     $ 437,022  
 
                       
 
                               
BASIC EARNINGS PER SHARE
  $ 0.71     $ 0.41     $ 1.97     $ 1.35  
 
                       
DILUTED EARNINGS PER SHARE
  $ 0.70     $ 0.41     $ 1.95     $ 1.34  
 
                       
 
                               
WEIGHTED-AVERAGE SHARES USED IN CALCULATING:
                               
BASIC EARNINGS PER SHARE
    291,408       288,958       292,613       323,006  
 
                       
DILUTED EARNINGS PER SHARE
    293,921       293,396       295,515       326,743  
 
                       

 


 

TABLE 2
Biogen Idec Inc.
September 30, 2008
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
                 
    September 30,     December 31,  
    2008     2007  
ASSETS
               
Cash, cash equivalents and marketable securities
  $ 1,227,828     $ 979,070  
Cash collateral received for loaned securities
    178,129       208,209  
Accounts receivable, net
    484,636       392,646  
Loaned securities
    158,971       204,433  
Inventory
    249,858       233,987  
Other current assets
    339,658       350,062  
 
           
Total current assets
    2,639,080       2,368,407  
 
           
Marketable securities
    717,182       932,271  
Property, plant and equipment, net
    1,579,938       1,497,383  
Intangible assets, net
    2,250,766       2,492,354  
Goodwill
    1,137,547       1,137,372  
Investments and other assets
    210,695       201,028  
 
           
TOTAL ASSETS
  $ 8,535,208     $ 8,628,815  
 
           
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Collateral payable on loaned securities
  $ 178,129     $ 208,209  
Current portion of notes payable
    10,215       1,511,135  
Other current liabilities
    797,528       469,831  
Long-term deferred tax liability
    440,164       521,525  
Notes payable
    1,042,427       51,843  
Other long-term liabilities
    298,267       331,977  
Shareholders’ equity
    5,768,478       5,534,295  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 8,535,208     $ 8,628,815  
 
           

 


 

TABLE 3
Biogen Idec Inc.
September 30, 2008
Condensed Consolidated Statements of Income — Non-GAAP
(in millions, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2008     2007     2008     2007  
EARNINGS PER SHARE
                               
 
GAAP earnings per share — Diluted
  $ 0.70     $ 0.41     $ 1.95     $ 1.34  
Adjustments to net income (as detailed below)
    0.28       0.17       0.78       0.54  
 
                       
Non-GAAP earnings per share — Diluted
  $ 0.98     $ 0.58     $ 2.73     $ 1.88  
 
                       
 
                               
An itemized reconciliation between net income on a GAAP basis and net income on a non-GAAP basis is as follows:
                               
 
                               
GAAP net income
  $ 206.8     $ 119.4     $ 576.5     $ 437.0  
Adjustments:
                               
COGS: Stock Option Expense
                      0.1  
R&D: Restructuring
    0.1       0.8       0.1       1.2  
R&D: Stock option expense
    2.4       3.5       6.5       9.4  
R&D: FIN 46 consolidation of Cardiokine
    1.7             4.0        
SG&A: Restructuring
    2.9             2.9       0.6  
SG&A: Stock option expense
    5.3       5.9       12.2       17.3  
Amortization of acquired intangible assets
    94.5       65.7       242.1       186.6  
In-process research and development related to the contingent consideration payment in 2008 associated with Conforma acquisition and the 2007 acquisition of Syntonix and consolidation of Cardiokine
          30.0       25.0       48.4  
Other income (expense), net: FIN 46 consolidation of Cardiokine and gain on sale of long-lived assets
    (1.7 )     (38.0 )     (4.0 )     (38.0 )
Income taxes: Income tax effect of reconciling items
    (24.1 )     (16.9 )     (58.6 )     (49.5 )
 
                       
Non-GAAP net income
  $ 287.9     $ 170.4     $ 806.7     $ 613.1  
 
                       
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
  $ 740.0       295.0     $ 2.51  
Adjustments:
                       
Stock option expense
    25.5                  
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 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 ongiong 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.
September 30, 2008
Product Revenues
(in thousands)
(unaudited)
                 
    Three Months Ended  
    September 30,  
    2008     2007  
PRODUCT REVENUES
               
Avonex®
  $ 573,493     $ 454,890  
Tysabri®
    171,169       62,903  
Amevive®
    27       87  
Zevalin®
    2,483       4,349  
Fumaderm®
    11,088       7,352  
 
           
Total product revenues
  $ 758,260     $ 529,581  
 
           
                 
    Nine Months Ended  
    September 30,  
    2008     2007  
PRODUCT REVENUES
               
Avonex®
  $ 1,636,754     $ 1,365,317  
Tysabri®
    433,005       140,202  
Amevive®
    279       305  
Zevalin®
    4,987       14,242  
Fumaderm®
    32,791       12,528  
 
           
Total product revenues
  $ 2,107,816     $ 1,532,594