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): April 21, 2011
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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0-19311
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33-0112644 |
(State or other jurisdiction
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(Commission
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(IRS Employer |
of incorporation)
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file number)
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Identification No.) |
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133 Boston Post Road, Weston, Massachusetts
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02493 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code (781) 464-2000
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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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.
On April 21, 2011, Biogen Idec Inc. issued a press release announcing its results of
operations and financial condition for the three months ended March 31, 2011. A copy of the press
release is furnished as Exhibit 99 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.
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Biogen Idec Inc.
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By: |
/s/ Robert A. Licht
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Robert A. Licht |
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Senior Vice President |
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Date: April 21, 2011
EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
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99
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Biogen Idecs press release dated April 21, 2011. |
exv99w1
Exhibit 99.1
Media Contact:
Christina Chan
Senior Manager, Public Affairs
Biogen Idec
Tel: (781) 464-3260
Investment Community Contact:
Kia Khaleghpour
Associate Director, Investor Relations
Biogen Idec
Tel: (781) 464-2442
FOR IMMEDIATE RELEASE
Biogen Idec Reports First Quarter 2011 Results
50% GAAP and 32% Non-GAAP Diluted EPS Growth Over First Quarter 2010
Weston, MA, April 21, 2011 Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the
discovery, development, manufacturing and commercialization of innovative therapies, today
announced its first quarter 2011 results.
First Quarter 2011 Highlights:
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First quarter revenues were $1.2 billion, an increase of 9% versus 2010. The increase was
driven primarily by the continued growth of TYSABRIÒ (natalizumab) revenues,
which increased 15% to $251 million, and AVONEXÒ (interferon beta-1a)
revenues, which increased 8% to $642 million. RITUXANÒ (rituximab) revenues
from our unconsolidated joint business arrangement were $256 million for the quarter,
essentially flat versus prior year. |
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Global in-market sales of TYSABRI in the first quarter of 2011 were $349 million, an
increase of 20% over the first quarter of 2010. The total was comprised of $170 million in
U.S. sales and $179 million in sales to markets outside the U.S. |
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On a reported basis, calculated in accordance with accounting principles generally accepted
in the U.S. (GAAP), first quarter 2011 GAAP diluted EPS were $1.20, an increase of 50% over
the first quarter of 2010. GAAP net income attributable to Biogen Idec for the quarter was
$294 million, an increase of 35% over the first quarter of 2010. |
MORE
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Non-GAAP diluted EPS for the first quarter of 2011 were $1.43, an increase of 32% over the
first quarter of 2010. Non-GAAP net income attributable to Biogen Idec for the first quarter
of 2011 was $349 million, an increase of 18% over the first quarter of 2010. A reconciliation
of our GAAP to non-GAAP results is included on Table 3 within this press release. |
As of March 31, 2011, Biogen Idec had cash, cash equivalents and marketable securities of
approximately $2.1 billion.
We had a very solid first quarter based on the performance of our three blockbuster products,
said George A. Scangos, Ph.D., Chief Executive Officer of Biogen Idec. We continued our
transformation into a lean, aggressive and focused company, and the reinvigoration of Research and
Development is well underway. We met several exciting pipeline milestones, including the positive
Phase III data read-out from the DEFINE trial for BG-12, our oral MS drug candidate, and the
enrollment of the first patient in our Phase III EMPOWER trial for dexpramipexole, a potential
treatment for ALS. We continue to unlock TYSABRIs potential through cutting edge science and are
encouraged by the CHMPs positive opinion to include anti-JC virus antibody status as an additional
risk factor for PML in the TYSABRI label. With these successes, we look forward to continue to
drive our core business and advance our deep late-stage pipeline.
Share Repurchases
During the first quarter of 2011, Biogen Idec repurchased 2.8 million shares of stock at a total
cost of $195 million.
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other
third-party sources, as of the end of March 2011, we estimate that approximately 58,400 patients
were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately
83,300 patients have ever been treated with TYSABRI in the post-marketing setting.
Other Products and Royalties
Revenues from other products in the first quarter of 2011 were $13 million, the same as in the
first quarter of 2010.
Table 4 provides individual product revenues.
Royalties were $26 million in the first quarter of 2011, the same as in the first quarter of 2010.
Corporate partner revenues in the first quarter of 2011 were $15 million, compared to $4 million in
the first quarter of 2010.
MORE
Recent Events
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On April 19, 2011, Biogen Idec announced that the European Medicines Agencys Committee
for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the
approval of AVONEX PEN for patients with relapsing multiple sclerosis and patients with a
single demyelinating event. |
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On April 19, 2011, Biogen Idec and Genentech, a member of the Roche Group, announced
that the U.S. Food and Drug Administration (FDA) approved RITUXAN, in combination with
corticosteroids, as a new medicine for adults with Wegeners Granulomatosis and
Microscopic Polyangiitis. |
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On April 18, 2011, Biogen Idec and Elan Corporation announced that the CHMP has adopted
a positive opinion for inclusion of an additional risk factor, anti-JC virus antibody
status, to the product label for TYSABRI in the European Union. The CHMP also recommended
a five year renewal of the Marketing Authorization for TYSABRI. |
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On April 11, 2011, Biogen Idec announced positive top-line results from DEFINE, the
first of two pivotal Phase III clinical trials designed to evaluate the investigational
oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with
relapsing-remitting multiple sclerosis. More details about BG-12 will be provided on the
companys earnings conference call. |
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On April 6, 2011, Biogen Idec submitted an investigational new drug application to the
FDA to evaluate its anti-beta-amyloid antibody BART (BIIB037) as a potential new treatment
for Alzheimers disease. Biogen Idec licensed BART from Swiss biotech company Neurimmune
in 2007. |
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On March 31, 2011, Biogen Idec and Knopp Biosciences announced the enrollment of the
first patient in EMPOWER, a multi-national Phase III study evaluating the efficacy, safety
and pharmacokinetics of dexpramipexole in patients with amyotrophic lateral sclerosis. |
Conference Call and Webcast
The companys earnings conference call for the first quarter will be broadcast via the internet at
7 a.m. ET on April 21, 2011, and will be accessible through the Investors section of Biogen Idecs
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 there subsequently through May 21, 2011.
MORE
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for
the treatment of serious diseases with a focus on neurological disorders. Founded in 1978, Biogen
Idec is the worlds oldest independent biotechnology company. Patients worldwide benefit from its
leading multiple sclerosis therapies, and the company generates more than $4 billion in annual
revenues. 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, including statements about the anticipated
development of programs in our clinical pipeline. These forward-looking statements may be
accompanied by such words as anticipate, believe, estimate, expect, forecast, intend,
may, plan, project, target, will and other words and terms of similar meaning. You
should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ
materially from those reflected in such statements, including our dependence on our three principal
products, AVONEX, RITUXAN and TYSABRI, the importance of TYSABRIs sales growth, product
competition, uncertainty of success in commercializing other products, the occurrence of adverse
safety events with our products, changes in the availability of reimbursement for our products,
adverse market and economic conditions, our dependence on collaborations and other third parties
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,
charges and other costs relating to our properties, problems with our manufacturing processes and
our reliance on third parties, fluctuations in our effective tax rate, our ability to attract and
retain qualified personnel, the risks of doing business internationally, our ability to protect our
intellectual property rights and the cost of doing so, product liability claims, fluctuations in
our operating results, 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, representation of activist shareholders on our board of directors,
and the other risks and uncertainties that are described in the Risk Factors section of our most
recent annual or quarterly report and in other reports we have filed with the SEC.
These statements are based on our current beliefs and expectations and speak only as of the date of
this press release. We do not undertake any obligation to publicly update any forward-looking
statements.
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TABLE 1
Biogen Idec Inc.
March 31, 2011
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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REVENUES |
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Product |
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$ |
907,102 |
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$ |
824,220 |
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Unconsolidated joint business |
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256,124 |
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254,928 |
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Royalties |
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25,578 |
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26,023 |
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Corporate partner |
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14,538 |
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3,689 |
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Total revenues |
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1,203,342 |
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1,108,860 |
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COSTS AND EXPENSES |
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Cost of sales, excluding amortization of acquired intangible assets |
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103,113 |
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97,055 |
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Research and development |
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293,633 |
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307,030 |
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Selling, general and administrative |
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244,516 |
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248,664 |
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Collaboration profit sharing |
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74,794 |
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63,557 |
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Amortization of acquired intangible assets |
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53,216 |
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48,889 |
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Restructuring charges |
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16,587 |
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Acquired in-process research and development |
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39,976 |
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Fair value adjustment of contingent consideration |
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1,200 |
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Total costs and expenses |
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787,059 |
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805,171 |
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Income from operations |
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416,283 |
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303,689 |
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Other income (expense), net |
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9,951 |
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(8,386 |
) |
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INCOME BEFORE INCOME TAX EXPENSE |
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426,234 |
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295,303 |
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Income tax expense |
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117,468 |
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75,310 |
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NET INCOME |
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$ |
308,766 |
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$ |
219,993 |
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Net income attributable to noncontrolling interest, net of tax |
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14,435 |
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2,551 |
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NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
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$ |
294,331 |
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$ |
217,442 |
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BASIC EARNINGS PER SHARE |
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$ |
1.22 |
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$ |
0.80 |
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DILUTED EARNINGS PER SHARE |
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$ |
1.20 |
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$ |
0.80 |
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WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
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BASIC EARNINGS PER SHARE |
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241,536 |
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269,922 |
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DILUTED EARNINGS PER SHARE |
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244,551 |
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272,703 |
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TABLE 2
Biogen Idec Inc.
March 31, 2011
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2011 |
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2010 |
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ASSETS |
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Cash, cash equivalents and marketable securities |
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$ |
1,228,545 |
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$ |
1,207,744 |
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Accounts receivable, net |
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687,609 |
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605,329 |
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Inventory |
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295,260 |
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289,066 |
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Other current assets |
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416,901 |
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438,281 |
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Total current assets |
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2,628,315 |
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2,540,420 |
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Marketable securities |
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885,444 |
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743,101 |
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Property, plant and equipment, net |
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1,673,502 |
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1,641,634 |
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Intangible assets, net |
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1,731,844 |
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1,772,826 |
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Goodwill |
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1,146,314 |
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1,146,314 |
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Investments and other assets |
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228,105 |
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248,198 |
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TOTAL ASSETS |
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$ |
8,293,524 |
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$ |
8,092,493 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current portion of notes payable and other
financing arrangements |
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$ |
134,779 |
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$ |
137,153 |
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Other current liabilities |
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844,067 |
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912,969 |
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Long-term deferred tax liability |
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218,504 |
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200,950 |
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Notes payable and line of credit |
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1,065,613 |
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1,066,379 |
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Other long-term liabilities |
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356,261 |
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325,599 |
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Shareholders equity |
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5,674,300 |
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5,449,443 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
8,293,524 |
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$ |
8,092,493 |
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TABLE 3
Biogen Idec Inc.
March 31, 2011
Condensed Consolidated Statements of Income Non-GAAP
(in millions, except per share amounts)
(unaudited)
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Three Months Ended |
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March 31, |
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2011 |
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2010 |
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EARNINGS PER SHARE |
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GAAP earnings per share Diluted |
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$ |
1.20 |
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$ |
0.80 |
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Adjustments to net income
attributable to Biogen Idec Inc. (as
detailed below) |
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0.23 |
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0.28 |
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Non-GAAP earnings per share Diluted |
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$ |
1.43 |
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$ |
1.08 |
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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:
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GAAP net income attributable to Biogen Idec Inc. |
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$ |
294.3 |
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$ |
217.4 |
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Adjustments: |
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R&D: Restructuring and severance |
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0.6 |
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R&D: Stock option expense |
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1.2 |
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1.6 |
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R&D: Expenses paid by Cardiokine |
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1.8 |
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SG&A: Restructuring and severance |
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4.3 |
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SG&A: Stock option expense |
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1.4 |
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10.8 |
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Amortization of acquired intangible assets |
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53.2 |
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48.9 |
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Restructuring charges |
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16.6 |
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Fair value adjustment of contingent consideration |
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1.2 |
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Acquired in-process research and development related to the
contingent consideration
payment made associated with the 2007 Syntonix acquisition |
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40.0 |
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Income tax expense: Income tax effect related to reconciling
items |
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(18.6 |
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(27.2 |
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Noncontrolling interest: Expenses paid by Cardiokine |
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(1.8 |
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Non-GAAP net income attributable to Biogen Idec Inc. |
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$ |
349.3 |
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$ |
296.4 |
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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, Syntonix
Pharmaceuticals, and Panima Pharmaceuticals AG and the consolidation of Knopp, Cardiokine and
Neurimmune. These include charges for in-process research and development and amortization of the
acquired intangible assets. Excluding these charges provides management and investors with a
supplemental measure of performance in which the Companys 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 exclude stock option expense from our non-GAAP R&D
expenses and SG&A expenses, but include the P&L impact of all other share-based 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.
March 31, 2011
Product Revenues
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
PRODUCT REVENUES |
|
|
|
|
|
|
|
|
|
Avonex® |
|
$ |
642,478 |
|
|
$ |
592,527 |
|
|
Tysabri® |
|
|
251,393 |
|
|
|
218,643 |
|
|
Fumaderm® |
|
|
12,506 |
|
|
|
13,050 |
|
|
Other |
|
|
725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues |
|
$ |
907,102 |
|
|
$ |
824,220 |
|
|
|
|
|
|
|
|