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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): October 20, 2009
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
         
Delaware   0-19311   33-0112644
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   file number)   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 20, 2009, Biogen Idec Inc. issued a press release announcing its results of operations and financial condition for the three months ended September 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 8.01 Other Events.
     On October 20, 2009, Biogen Idec Inc. announced that its Board of Directors authorized the repurchase of its common stock in an amount of up to $1 billion. The company intends to retire shares following repurchase on the open market. This repurchase program does not have an expiration date.
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   
    Senior Vice President   
 
Date: October 20, 2009

 


 

EXHIBIT INDEX
     
Exhibit    
Number   Description
 
99.1
  Biogen Idec’s press release dated October 20, 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 Third Quarter 2009 Results
14% non-GAAP and 36% GAAP Diluted EPS Growth over Prior Year and
Board Authorizes $1 Billion Share Repurchase Program
Cambridge, MA, October 20, 2009 — Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its third quarter 2009 results.
Third Quarter 2009 Highlights:
  Total revenues were $1.12 billion, an increase of 3% from $1.09 billion in the third quarter of 2008. The increase was driven primarily by the continued growth of TYSABRI® (natalizumab) revenues, which were up 21% over the prior year to $207 million for the quarter.
 
  On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), third quarter 2009 diluted earnings per share (EPS) was $0.95, an increase of 36% from $0.70 in the third quarter of 2008. GAAP net income attributable to Biogen Idec for the third quarter of 2009 was $278 million, a 34% increase over the prior year. The year over year increase in GAAP net income was primarily driven by a reduction in amortization of acquired intangible assets resulting from the significant increase in the expected lifetime revenue of AVONEX® following the issuance in September 2009 of the U.S. patent covering the treatment of multiple sclerosis with AVONEX.

 


 

Page 2 Biogen Idec Reports Third Quarter 2009 Results
  Non-GAAP diluted EPS for the third quarter of 2009 was $1.12, an increase of 14% from $0.98 in the third quarter of 2008. Non-GAAP net income attributable to Biogen Idec for the third quarter was $326 million, a 13% increase over the prior year. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
“Our strong performance this quarter puts us on pace to achieve our 2009 financial goals,” said Biogen Idec CEO James C. Mullen. “Equally important, we made significant progress advancing the development of key pipeline programs.”
Revenue Performance
Revenues from AVONEX, one of Biogen Idec’s therapies for patients with relapsing forms of multiple sclerosis (MS), increased 1% to $580 million in the third quarter of 2009 as compared to $573 million in the third quarter of 2008. U.S. sales of AVONEX increased 8% to $348 million year over year. Rest of world sales of AVONEX decreased 8% to $232 million year over year.
Revenues for the third quarter of 2009 included $284 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 $670 million in the third quarter 2009, as compared to $655 million in the third quarter of 2008, an increase of 2%.
During the third quarter of 2009, Biogen Idec recognized revenue of $207 million related to TYSABRI. This amount is comprised of:
  $59 million related to product sold through Elan in the U.S. (based on $131 million of U.S. in-market sales) and milestone amortization; and
 
  $148 million related to product sold in rest of world markets and milestone amortization.
Based upon data available to us through the TOUCH® prescribing program and other third-party sources as of the end of September 2009, we estimate that approximately 46,200 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 60,700 patients have ever been treated with TYSABRI in the post-marketing setting.
Revenues from other products in the third quarter of 2009 were $15 million, as compared to $14 million in the third quarter of 2008.
Table 4 provides individual product revenues.
Royalty revenues were $35 million in the third quarter of both 2009 and 2008.

 


 

Page 3 Biogen Idec Reports Third Quarter 2009 Results
Share Repurchase Program
In October 2009, Biogen Idec’s Board of Directors authorized the repurchase of up to $1 billion of common stock. This is in addition to the 6 million shares remaining from our previous share repurchase authorization. While we have used the prior program principally for share stabilization, this new $1 billion authorization is intended to reduce our shares outstanding, with the objective of returning excess cash to shareholders. Shares will be purchased on the open market and retired. The authorization is open-ended and is expected to be accretive to EPS. The repurchase reflects our confidence in the long-term value of our common stock and we believe it is an effective way of returning excess cash to our shareholders.
“We are confident in the projected cash flows from our core products, which allow us to return capital to shareholders while continuing to fund future growth through our pipeline. Furthermore, we believe that this will not hamper our ability to capitalize on strategic external growth opportunities” stated Biogen Idec CFO Paul J. Clancy.
The company has approximately 289 million shares of common stock outstanding at the end of September 2009. The company plans to update investors on the progress of this program on future quarterly earnings calls.
Financial Guidance
Biogen Idec updated its 2009 full year guidance as follows:
    Revenue growth is expected to be in the mid to high single digits on a year over year basis.
 
    R&D expense is expected to be between 28% and 30% of revenue.
 
    SG&A expense is expected to be between 19% and 20% of revenue.
 
    Operating expense, excluding collaboration profit share, is expected to be between $2.1 and $2.2 billion.
 
    Non GAAP tax rate is expected to be between 28% and 30%; GAAP tax rate is expected to be between 29% and 31%.
 
    Non-GAAP diluted EPS is expected to be above $3.85. GAAP diluted EPS is expected to be above $2.97.
 
    Our capital expenditure outlook for the full year is in the range of $150-$160 million.
This guidance excludes any significant business development activity.

 


 

Page 4 Biogen Idec Reports Third Quarter 2009 Results
Recent Highlights
  On October 19, 2009, Biogen Idec and Biovitrum AB announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients. The decision to advance the program is based on promising data from a Phase 1/2a open-label, multi-center, safety dose-escalation and pharmacokinetic study of intravenous rFIXFc in severe, previously treated hemophilia B patients. rFIXFc was well tolerated in the study. In addition, rFIXFc demonstrated a prolonged half-life compared to historical data for existing therapies, supporting advancement of the program.
 
  On October 16, 2009, Biogen Idec announced that it extended the tender offer to purchase all of the outstanding shares of Facet Biotech Corporation to midnight New York City time on December 16, 2009, unless otherwise extended. The tender offer was previously set to expire at midnight New York City time on October 19, 2009. The offer price remained unchanged at $14.50 per share in cash.
 
  On September 17, 2009, Genentech, Inc. and Biogen Idec announced that a Phase 3 study (PRIMA) met its endpoint during a pre-planned interim analysis, and the study was stopped early on the recommendation of an independent data and safety monitoring board. The primary endpoint was progression-free survival of patients with follicular lymphoma who continued receiving RITUXAN alone after responding to RITUXAN and chemotherapy compared to those who did not continue to receive RITUXAN. The safety profile of RITUXAN observed in the study was consistent with that previously reported.
 
  On September 15, 2009, Biogen Idec disclosed that the company had been issued U.S. patent no. 7,588,755 for the use of beta interferon for immunomodulation or treating a viral condition, viral disease, cancers or tumors. This patent covers the treatment of multiple sclerosis with AVONEX, which is Biogen Idec’s brand of recombinant beta interferon. This patent will expire in September 2026.
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 20, 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 November 20, 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

 


 

Page 5 Biogen Idec Reports Third Quarter 2009 Results
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 position 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, 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, credit and financial market conditions, 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 described in the Risk Factors section of 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.
September 30, 2009
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2009     2008     2009     2008  
REVENUES
                               
Product
  $ 801,689     $ 758,260     $ 2,326,067     $ 2,107,816  
Unconsolidated joint business
    283,919       298,979       838,307       825,024  
Royalties
    34,538       35,162       83,631       87,258  
Corporate partner
    372       563       2,287       8,496  
 
                       
Total revenues
    1,120,518       1,092,964       3,250,292       3,028,594  
 
                       
COST AND EXPENSES
                               
Cost of sales
    93,486       107,493       282,404       300,828  
Research and development
    304,055       268,800       999,986       779,291  
Selling, general and administrative
    226,755       232,824       669,415       694,342  
Amortization of acquired intangible assets
    51,347       94,464       233,830       242,114  
Collaboration profit sharing
    60,697       43,533       152,608       98,368  
In-process research and development
                      25,000  
 
                       
Total cost and expenses
    736,340       747,114       2,338,243       2,139,943  
 
                       
Income from operations
    384,178       345,850       912,049       888,651  
Other income (expense), net
    9,360       (23,713 )     30,886       (24,651 )
 
                       
INCOME BEFORE INCOME TAXES
    393,538       322,137       942,935       864,000  
Income taxes
    113,936       114,337       271,869       282,320  
 
                       
NET INCOME
  $ 279,602     $ 207,800     $ 671,066     $ 581,680  
 
                       
Less: Net income attributable to noncontrolling interests, net of tax
    1,939       1,012       6,571       5,167  
 
                       
NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC.
  $ 277,663     $ 206,788     $ 664,495     $ 576,513  
 
                       
BASIC EARNINGS PER SHARE
  $ 0.96     $ 0.71     $ 2.30     $ 1.97  
 
                       
DILUTED EARNINGS PER SHARE
  $ 0.95     $ 0.70     $ 2.28     $ 1.95  
 
                       
WEIGHTED-AVERAGE SHARES USED IN CALCULATING:
                               
BASIC EARNINGS PER SHARE
    288,917       291,408       288,416       292,613  
 
                       
DILUTED EARNINGS PER SHARE
    291,037       293,921       290,368       295,515  
 
                       

 


 

TABLE 2
Biogen Idec Inc.
September 30, 2009
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
                 
    September 30,     December 31,  
    2009     2008  
ASSETS
               
Cash, cash equivalents and marketable securities
  $ 1,407,676     $ 1,341,971  
Collateral received for loaned securities
          29,991  
Accounts receivable, net
    550,995       446,665  
Loaned securities
          29,446  
Inventory
    278,686       263,602  
Other current assets
    334,902       346,325  
 
           
Total current assets
    2,572,259       2,458,000  
 
           
Marketable securities
    1,497,447       891,406  
Property, plant and equipment, net
    1,634,696       1,594,754  
Intangible assets, net
    1,927,115       2,161,058  
Goodwill
    1,138,621       1,138,621  
Investments and other assets
    256,299       235,152  
 
           
TOTAL ASSETS
  $ 9,026,437     $ 8,478,991  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Collateral payable on loaned securities
  $     $ 29,991  
Current portion of notes payable
    15,452       27,667  
Other current liabilities
    705,916       865,564  
Long-term deferred tax liability
    289,654       356,017  
Notes payable
    1,085,844       1,085,431  
Other long-term liabilities
    331,761       280,369  
Shareholders’ equity
    6,597,810       5,833,952  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 9,026,437     $ 8,478,991  
 
           

 


 

TABLE 3
Biogen Idec Inc.
September 30, 2009
Condensed Consolidated Statements of Income — Non-GAAP
(in millions, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2009     2008     2009     2008  
EARNINGS PER SHARE
                               
GAAP earnings per share — Diluted
  $ 0.95     $ 0.70     $ 2.28     $ 1.95  
Adjustments to net income attributable to Biogen Idec, Inc. (as detailed below)
    0.17       0.28       0.64       0.78  
 
                       
Non-GAAP earnings per share — Diluted
  $ 1.12     $ 0.98     $ 2.92     $ 2.73  
 
                       
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.
  $ 277.7     $ 206.8     $ 664.5     $ 576.5  
Adjustments:
                               
R&D: Restructuring
    0.7       0.1       2.5       0.1  
R&D: Stock option expense
    2.6       2.4       6.2       6.5  
R&D: Expenses paid by Cardiokine
    2.2       1.7       6.0       4.0  
SG&A: Restructuring
    0.1       2.9       0.4       2.9  
SG&A: Stock option expense
    5.8       5.3       15.3       12.2  
Amortization of acquired intangible assets
    51.4       94.5       233.8       242.1  
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
    (12.5 )     (24.1 )     (72.8 )     (58.6 )
Noncontrolling interest: Expenses paid by Cardiokine
    (2.2 )     (1.7 )     (6.0 )     (4.0 )
 
                       
Non-GAAP net income attributable to Biogen Idec, Inc.
  $ 325.8     $ 287.9     $ 849.9     $ 806.7  
 
                       
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.
  $ 863.4       291.0     $ 2.97  
Adjustments:
                       
In-process research and development
    40.0                  
Stock option expense
    29.1                  
Amortization of acquired intangible assets
    282.9                  
Other items
    1.6                  
Income taxes
    (95.0 )                
 
                 
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 the accounting standard for share-based payments.
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.
September 30, 2009
Product Revenues
(in thousands)
(unaudited)
                 
    Three Months Ended  
    September 30,  
    2009     2008  
PRODUCT REVENUES
               
 
               
Avonex®
  $ 579,979     $ 573,493  
 
               
Tysabri®
    207,013       171,169  
 
               
Fumaderm tm
    12,634       11,088  
 
               
Other
    2,063       2,510  
 
               
 
           
Total product revenues
  $ 801,689     $ 758,260  
 
           
                 
    Nine Months Ended  
    September 30,  
    2009     2008  
PRODUCT REVENUES
               
 
               
Avonex®
  $ 1,726,428     $ 1,636,754  
 
               
Tysabri®
    559,842       433,005  
 
               
Fumaderm TM
    35,403       32,791  
 
               
Other
    4,394       5,266  
 
               
 
           
Total product revenues
  $ 2,326,067     $ 2,107,816