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 26, 2010
Biogen Idec Inc.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction
of incorporation)
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0-19311
(Commission
file number)
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33-0112644
(IRS Employer
Identification No.) |
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133 Boston Post Road, Weston, Massachusetts
(Address of principal executive offices)
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02493
(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))
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Item 2.02 |
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Results of Operations and Financial Condition. |
On October 26, 2010, Biogen Idec Inc. issued a press release announcing its results of
operations and financial condition for the three months ended September 30, 2010. 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.
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Item 9.01 |
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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: October 26, 2010
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 October 26, 2010. |
exv99
Media Contact:
Christina Chan
Senior Manager, Public Affairs
Biogen Idec
Tel: (781) 464-3260
Investment Community Contact:
John Applegate
Associate Director, Investor Relations
Biogen Idec
Tel: (781) 464-2442
FOR IMMEDIATE RELEASE
Biogen Idec Reports Third Quarter 2010 Results
Double Digit EPS Growth
Substantial Progress on TYSABRI® Risk Stratification
Weston, MA, October 26, 2010 Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in
the discovery, development, manufacturing, and commercialization of innovative therapies, today
announced its third quarter 2010 results.
Third Quarter 2010 Highlights
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Third quarter revenues were $1.2 billion, an increase of 5% over the third quarter of 2009,
driven primarily by AVONEX® (interferon beta-1a) revenues, which increased 11% to
$644 million and TYSABRI® (natalizumab) revenues, which increased 7% to $221
million. RITUXAN® (rituximab) revenues decreased 9% to $258 million. |
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Global in-market net sales of TYSABRI in the third quarter of 2010 were $307 million, an
increase of 9% over the third quarter of 2009, of which $151 million were in the U.S. and $156
million were in rest of world markets. |
Page 2 Biogen Idec Reports Third Quarter 2010 Results
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Third quarter 2010 GAAP diluted EPS were $1.05, an increase of 11% over the third quarter
of 2009. GAAP net income attributable to Biogen Idec for the quarter was $254 million, a
decrease of 8% compared to the third quarter of 2009. |
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Third quarter 2010 non-GAAP diluted EPS were $1.35, an increase of 21% over the third
quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was $328
million, an increase of 1% over the third quarter of 2009. A reconciliation of Biogen Idecs
GAAP to non-GAAP results is included on Table 3 within this press release. |
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Year over year comparisons are impacted by an agreement with Knopp Neurosciences. The
impact of this agreement on results for the third quarter of 2010 was $86 million and $26
million on a GAAP and non-GAAP basis respectively. Additional information on this agreement
may be found in the slide presentation that accompanies our third quarter earnings conference
call. |
As of September 30, 2010, Biogen Idec had cash, cash equivalents and marketable securities of
approximately $1.4 billion.
We had another solid quarter driven primarily by increased AVONEX and TYSABRI revenues, said
George A. Scangos, Ph.D., Chief Executive Officer, Biogen Idec, We also continued to demonstrate
our leadership position in MS with our strong showing at this years ECTRIMS Congress, while
expanding our neurology foothold with the licensing agreement for KNS-760704 (dexpramipexole) for
the treatment of ALS.
Progress on TYSABRI Risk Stratification
The company also announced that it and its partner, Elan Corporation, plc, have made substantial
progress on TYSABRI risk stratification efforts. Data presented at the 26th Congress of the
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) further supported the
potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies
in human plasma or serum. The detection of anti-JCV antibodies may provide a means to segment, or
stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI and
assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but
serious, brain infection. The companies have also completed preliminary discussions with
regulators in the US and Europe about these data and plan to submit labeling changes to both
agencies by the first quarter of 2011.
Other Products and Royalties
Revenues from other products in the third quarter of 2010 were $12 million compared to $15 million
in the third quarter of 2009.
Table 4 provides individual product revenues.
Royalty revenues were $36 million in the third quarter of 2010, compared to $35 million in the
third quarter of 2009.
Page 3 Biogen Idec Reports Third Quarter 2010 Results
Corporate partner revenues were $5 million in the third quarter of 2010, versus less than $1
million in the third quarter of 2009.
Share Repurchase Programs
In April 2010, the Board approved a $1.5 billion share repurchase program. During the third
quarter of 2010, Biogen Idec completed the program by repurchasing and retiring 9 million shares at
a total cost of $468 million. In total, since the beginning of the year, Biogen Idec has purchased
40.3 million shares for a total cost of approximately $2.1 billion. Biogen Idecs fully-diluted
weighted average shares outstanding were approximately 242 million for the third quarter.
TYSABRI Patient Growth
Based upon data available to Biogen Idec through the TOUCH® prescribing program and
other third-party sources, Biogen Idec estimates that as of the end of September 2010 approximately
55,100 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively
approximately 75,500 patients have ever been treated with TYSABRI in the post-marketing setting.
Recent Events
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On October 21, 2010, Biogen Idec and Genentech, Inc., a wholly owned member of the Roche
Group, announced that they had agreed to amend their collaboration on antibodies targeting
CD20. The companies agreed that Genentech will have responsibility for the further
development of ocrelizumab in multiple sclerosis. Genentech will fund 100% of the costs
going forward and will be responsible for development and commercialization. Biogen Idec
will receive tiered, double-digit royalties on US sales of ocrelizumab that will
approximate its current 30% interest in the compound. Further, the companies agreed that
the commercialization of ocrelizumab will not impact the current profit share of RITUXAN.
In addition, Biogen Idec and Genentech have agreed that Biogen Idec will increase its share
of the losses and profits related to the development and commercialization of GA101 in the
US to 35% from 30%. |
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On October 6, 2010, Biogen Idec announced that more than 45 company- and
partner-sponsored platform and poster presentations were to be presented during the 26th
ECTRIMS in Gothenburg, Sweden, October 13 16, 2010. ECTRIMS is the worlds largest
medical meeting dedicated to research and advances in multiple sclerosis. Data presented
included Biogen Idecs currently marketed products, TYSABRI and AVONEX, as well as four
late-stage programs: prolonged-release fampridine tablets, the oral compound BG-12
(dimethyl fumarate), PEGylated interferon beta-1a and daclizumab. |
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On August 24, 2010, Biogen Idec and Elan Corporation, plc announced data had been
published in the Annals of Neurology on an investigational, two-step assay to detect
anti-JCV antibodies in human serum and plasma. This assay is currently being evaluated in |
Page 4 Biogen Idec Reports Third Quarter 2010 Results
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clinical studies as a potential tool for risk stratification in TYSABRI-treated patients.
Data from this preliminary analysis have been released online and were published in the
journals September issue. |
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On August 18, 2010, Biogen Idec and Knopp Neurosciences announced they had entered into
an exclusive, worldwide license agreement under which Biogen Idec will develop and
commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral
sclerosis (ALS), also known as Lou Gehrigs disease, and potentially other indications. |
Conference Call and Webcast
Biogen Idecs earnings conference call for the third quarter will be broadcast via the Internet at
8:30 a.m. ET on October 26, 2010, and will be accessible through the Investors section of
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 through November 30, 2010.
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 worldwide benefit from Biogen Idecs
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 forward-looking statements may be
accompanied by such words as anticipate, believe, estimate, expect, forecast, intend,
may, plan, 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, problems with manufacturing
processes and our reliance on third parties, 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, charges and other
costs relating to our properties, fluctuations in our effective tax rate, our ability to attract
and retain qualified personnel, market and economic conditions, the risks of doing business
internationally, our ability to protect our intellectual property rights and the cost of doing so,
Page 5 Biogen Idec Reports Third Quarter 2010 Results
proxy contests and representation of activist shareholders on our board of directors, 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 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. 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, 2010
Consolidated Statements of Income
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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REVENUES |
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Product |
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$ |
876,850 |
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$ |
801,689 |
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$ |
2,560,305 |
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$ |
2,326,067 |
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Unconsolidated joint business |
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257,981 |
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283,919 |
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819,281 |
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838,307 |
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Royalties |
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35,952 |
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34,538 |
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92,072 |
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83,631 |
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Corporate partner |
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5,006 |
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372 |
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25,693 |
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2,287 |
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Total revenues |
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1,175,789 |
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1,120,518 |
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3,497,351 |
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3,250,292 |
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COSTS AND EXPENSES |
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Cost of sales, excluding amortization of acquired intangible assets |
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95,918 |
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|
93,486 |
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|
299,958 |
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|
282,404 |
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Research and development |
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319,054 |
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304,055 |
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957,759 |
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999,986 |
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Selling, general and administrative |
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244,160 |
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226,755 |
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755,147 |
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669,415 |
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Collaboration profit sharing |
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63,991 |
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60,697 |
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190,240 |
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152,608 |
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Amortization of acquired intangible assets |
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53,531 |
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51,347 |
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155,568 |
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233,830 |
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Acquired in-process research and development |
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205,000 |
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244,976 |
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Total costs and expenses |
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981,654 |
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736,340 |
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2,603,648 |
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2,338,243 |
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Income from operations |
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194,135 |
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|
384,178 |
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|
893,703 |
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912,049 |
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Other income (expense), net |
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(6,945 |
) |
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9,360 |
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(14,318 |
) |
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30,886 |
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INCOME BEFORE INCOME TAX EXPENSE |
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187,190 |
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393,538 |
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|
879,385 |
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942,935 |
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Income tax expense |
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75,011 |
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|
113,936 |
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252,564 |
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271,869 |
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NET INCOME |
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$ |
112,179 |
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$ |
279,602 |
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$ |
626,821 |
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$ |
671,066 |
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Net income (loss) attributable to noncontrolling interest, net of tax |
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(141,936 |
) |
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1,939 |
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(138,174 |
) |
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6,571 |
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NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
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$ |
254,115 |
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$ |
277,663 |
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$ |
764,995 |
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$ |
664,495 |
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BASIC EARNINGS PER SHARE |
|
$ |
1.06 |
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$ |
0.96 |
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$ |
2.98 |
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$ |
2.30 |
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DILUTED EARNINGS PER SHARE |
|
$ |
1.05 |
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$ |
0.95 |
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$ |
2.95 |
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$ |
2.28 |
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WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
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BASIC EARNINGS PER SHARE |
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|
239,864 |
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|
|
288,917 |
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|
256,586 |
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|
288,416 |
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DILUTED EARNINGS PER SHARE |
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|
242,313 |
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|
291,037 |
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|
258,906 |
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|
290,368 |
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TABLE 2
Biogen Idec Inc.
September 30, 2010
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
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September 30, |
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December 31, |
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2010 |
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2009 |
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ASSETS |
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Cash, cash equivalents and marketable securities |
|
$ |
824,592 |
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$ |
1,263,724 |
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Accounts receivable, net |
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|
616,697 |
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|
551,208 |
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Inventory |
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|
269,313 |
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|
293,950 |
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Other current assets |
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|
420,529 |
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|
371,713 |
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Total current assets |
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2,131,131 |
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|
2,480,595 |
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Marketable securities |
|
|
560,006 |
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|
|
1,194,080 |
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Property, plant and equipment, net |
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|
1,641,791 |
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|
|
1,637,083 |
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Intangible assets, net |
|
|
1,715,342 |
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|
|
1,871,078 |
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Goodwill |
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1,138,621 |
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|
1,138,621 |
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Investments and other assets |
|
|
207,256 |
|
|
|
230,397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
7,394,147 |
|
|
$ |
8,551,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of notes payable and line of credit |
|
$ |
11,296 |
|
|
$ |
19,762 |
|
|
|
|
|
|
|
|
|
|
Other current liabilities |
|
|
813,184 |
|
|
|
695,180 |
|
|
|
|
|
|
|
|
|
|
Long-term deferred tax liability |
|
|
174,615 |
|
|
|
240,618 |
|
|
|
|
|
|
|
|
|
|
Notes payable and line of credit |
|
|
1,068,776 |
|
|
|
1,080,207 |
|
|
|
|
|
|
|
|
|
|
Other long-term liabilities |
|
|
256,075 |
|
|
|
254,205 |
|
|
|
|
|
|
|
|
|
|
Shareholders equity |
|
|
5,070,201 |
|
|
|
6,261,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
7,394,147 |
|
|
$ |
8,551,854 |
|
|
|
|
|
|
|
|
TABLE 3
Biogen Idec Inc.
September 30, 2010
Condensed Consolidated Statements of Income Non-GAAP
(in millions, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
EARNINGS PER SHARE |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP earnings per share Diluted |
|
$ |
1.05 |
|
|
$ |
0.95 |
|
|
$ |
2.95 |
|
|
$ |
2.28 |
|
Adjustments to net income attributable to Biogen Idec Inc. (as detailed below) |
|
|
0.30 |
|
|
|
0.17 |
|
|
|
0.78 |
|
|
|
0.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP earnings per share Diluted |
|
$ |
1.35 |
|
|
$ |
1.12 |
|
|
$ |
3.73 |
|
|
$ |
2.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. |
|
$ |
254.1 |
|
|
$ |
277.7 |
|
|
$ |
765.0 |
|
|
$ |
664.5 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D: Restructuring and severance |
|
|
|
|
|
|
0.7 |
|
|
|
1.2 |
|
|
|
2.5 |
|
R&D: Stock option expense |
|
|
2.4 |
|
|
|
2.6 |
|
|
|
4.9 |
|
|
|
6.2 |
|
R&D: Expenses paid by Cardiokine |
|
|
1.1 |
|
|
|
2.2 |
|
|
|
4.9 |
|
|
|
6.0 |
|
SG&A: Restructuring and severance |
|
|
|
|
|
|
0.1 |
|
|
|
5.7 |
|
|
|
0.4 |
|
SG&A: Stock option expense |
|
|
3.5 |
|
|
|
5.8 |
|
|
|
23.0 |
|
|
|
15.3 |
|
Amortization of acquired intangible assets |
|
|
53.5 |
|
|
|
51.4 |
|
|
|
155.6 |
|
|
|
233.8 |
|
Acquired in-process research and development related to the consolidation of
Knopp and the contingent consideration payment made associated with the
2007 Syntonix acquisition |
|
|
205.0 |
|
|
|
|
|
|
|
245.0 |
|
|
|
|
|
Income tax expense: Income tax effect related to reconciling items |
|
|
(45.4 |
) |
|
|
(12.5 |
) |
|
|
(87.7 |
) |
|
|
(72.8 |
) |
Noncontrolling interest: Consolidation of Knopp and expenses paid by Cardiokine |
|
|
(146.1 |
) |
|
|
(2.2 |
) |
|
|
(149.9 |
) |
|
|
(6.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income attributable to Biogen Idec Inc. |
|
$ |
328.1 |
|
|
$ |
325.8 |
|
|
$ |
967.7 |
|
|
$ |
849.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 Knopp, 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 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 restricted stock grants 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, 2010
Product Revenues
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
PRODUCT REVENUES |
|
|
|
|
|
|
|
|
Avonex® |
|
$ |
643,623 |
|
|
$ |
579,979 |
|
Tysabri® |
|
|
220,739 |
|
|
|
207,013 |
|
Fumaderm® |
|
|
12,365 |
|
|
|
12,634 |
|
Other |
|
|
123 |
|
|
|
2,063 |
|
|
|
|
|
|
|
|
Total product revenues |
|
$ |
876,850 |
|
|
$ |
801,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2010 |
|
|
2009 |
|
PRODUCT REVENUES |
|
|
|
|
|
|
|
|
Avonex® |
|
$ |
1,864,284 |
|
|
$ |
1,726,428 |
|
Tysabri® |
|
|
658,621 |
|
|
|
559,842 |
|
Fumaderm® |
|
|
37,255 |
|
|
|
35,403 |
|
Other |
|
|
145 |
|
|
|
4,394 |
|
|
|
|
|
|
|
|
Total product revenues |
|
$ |
2,560,305 |
|
|
$ |
2,326,067 |
|
|
|
|
|
|
|
|