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 20, 2010
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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14 Cambridge Center, Cambridge, Massachusetts
(Address of principal executive offices)
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02142
(Zip Code) |
Registrants 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):
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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 20, 2010, Biogen Idec Inc. issued a press release announcing its results of
operations and financial condition for the three months ended March 31, 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.
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 20, 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 April 20, 2010. |
exv99
Exhibit 99.1
Media Contact:
Amy Reilly
Associate Director, Public Affairs
Biogen Idec
Tel: (617) 914-6524
Investment Community Contacts:
John Applegate or Kia Khaleghpour
Investor Relations
Biogen Idec
Tel: (617) 679-2812
FOR IMMEDIATE RELEASE
Biogen Idec Reports First Quarter 2010 Results
TYSABRI® Revenues Increase 32% Year over Year
Cambridge, MA, April 20, 2010 Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in
the discovery, development, manufacturing, and commercialization of innovative therapies, today
announced its first quarter 2010 results.
First Quarter 2010 Highlights:
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First quarter revenues were $1.1 billion, an increase of 7% over the first quarter of 2009,
driven primarily by the continued growth of TYSABRI (natalizumab) revenues, which increased
32% to $219 million in the quarter, and AVONEX® (interferon beta-1a) revenues,
which increased 7% to $593 million. RITUXAN® (rituximab) revenues decreased 9% to
$255 million. |
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Global in-market net sales of TYSABRI in the first quarter of 2010 were $292 million, an
increase of 28% over the first quarter of 2009, of which $135 million were in the U.S. and
$157 million were in rest of world markets. |
Page 2 Biogen Idec Reports First Quarter 2010 Results
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First quarter 2010 GAAP diluted EPS were $0.80, a decrease of 5% over the first quarter of
2009. GAAP net income attributable to Biogen Idec for the quarter was $217 million, a
decrease of 11% over the first quarter of 2009. |
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First quarter 2010 non-GAAP diluted EPS were $1.08, an increase of 3% over the
first quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was
$296 million, a decrease of 3% over the first quarter of 2009. A reconciliation of our GAAP
to non-GAAP results is included on Table 3 within this press release. |
First quarter GAAP and non-GAAP results include a $14 million charge resulting from the impairment
of our investment in AVEO Pharmaceuticals following its initial public offering in March of this
year. First quarter results were also impacted by a $13 million
charge due to the recently approved Patient Protection and Affordable Care Act. This is the result
of expanded 340(B) pricing and increased Medicaid rebates mandated by this legislation.
As of March 31, 2010 Biogen Idec had cash, cash equivalents and marketable securities of
approximately $2.2 billion.
We continue to execute on our strategy and actively position Biogen Idec for future growth, said
James C. Mullen, Biogen Idecs President and CEO. We have several efforts underway that have the
potential to drive long-term TYSABRI adoption, including the JC virus assay and SURPASS comparative
study, our pipeline has great prospects with six programs in registrational trials, and we have
solid financial fundamentals with strong cash flow.
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other
third-party sources, Biogen Idec estimates that as of the end of March 2010 approximately 50,300
patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively
approximately 67,700 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 2010 were $13 million, the same as in the
first quarter of 2009.
Table 4 provides individual product revenues.
Royalties were $26 million in the first quarter of 2010 compared to $24 million in the first
quarter of 2009.
Page 3 Biogen Idec Reports First Quarter 2010 Results
Share Repurchase Programs
During the first quarter of 2010, Biogen Idec completed the $1 billion share repurchase program
announced during the fourth quarter of 2009. The Company repurchased and retired 10.5 million
shares at a total cost of $577.6 million during the quarter.
In April 2010, the Board of Directors authorized an additional $1.5 billion share repurchase
program with the objective of returning excess cash to shareholders. The shares repurchased under
this authorization will be retired. The authorization is open-ended and we expect that repurchases
will be made over a longer period than our recently completed $1 billion share repurchase program.
Recent Events
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Biogen Idec presented 38 company-sponsored platform and poster presentations during the
American Academy of Neurologys (AAN) 62nd Annual Meeting in Toronto, April 10 17, 2010.
The AAN Annual Meeting is the worlds largest gathering of neurologists. These
presentations included data on five compounds that are marketed or currently in
development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS),
including two approved therapies for MS, TYSABRI and AVONEX, and three promising compounds
in the late stages of development: BG-12 (dimethyl fumarate), PEGylated interferon beta-1a
and daclizumab. |
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On April 1, 2010, Roche announced that Genentech, Inc., a member of the Roche Group,
had submitted in collaboration with Biogen Idec a supplemental Biologics License
Application to the U.S. Food and Drug Administration (FDA) to extend the current label for
RITUXAN in non-Hodgkins lymphoma to include maintenance treatment for previously
untreated patients with advanced follicular lymphoma. |
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On March 24, 2010, Biogen Idec and Elan Corporation, plc announced enrollment of the
first patient in a global Phase 3b, randomized, rater-blinded, active-controlled study
designed to evaluate switching to TYSABRI from Copaxone® (glatiramer acetate)
or Rebif® (interferon beta-1a) in patients with relapsing remitting MS (RRMS).
The study, called SURPASS, is expected to enroll 1,800 patients in 27 countries and
provide direct comparative data of different treatment options for RRMS patients who
experience breakthrough disease activity. |
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On March 22, 2010, Biogen Idec announced that Dr. Eric K. Rowinsky and Dr. Stephen A.
Sherwin had been appointed to its Board of Directors pursuant to an agreement with Carl C.
Icahn and certain funds affiliated with Mr. Icahn. |
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Under the terms of the agreement, the Icahn Group agreed to vote its shares at the 2010
Annual Meeting for Biogen Idecs director nominees, who will include current directors
Nancy L. Leaming and Brian S. Posner as well as Drs. Rowinsky and Sherwin. |
Page 4 Biogen Idec Reports First Quarter 2010 Results
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On March 8, 2010, Roche and Biogen Idec announced their decision to suspend ocrelizumab
treatment of patients in the rheumatoid arthritis program. The decision follows the
recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board
based on their assessment of the studies in RA (SCRIPT, FEATURE, FILM and STAGE) and lupus
(BELONG and BEGIN). |
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In March, 2010, Biogen Idec and Elan began enrolling patients in two clinical studies,
STRATIFY 1 and 2, to evaluate the potential clinical utility of a blood test that is
designed to detect antibodies to the JC virus. These studies are intended to define the
prevalence of serum JC virus antibody in patients with
relapsing MS receiving or considering treatment with TYSABRI and to evaluate the potential
to stratify patients into lower or higher risk for developing PML based on antibody status. |
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On February 18, 2010, Genentech and Biogen Idec announced that the FDA approved RITUXAN
in combination with fludarabine and cyclophosphamide for people with previously untreated
and previously treated CD20-positive chronic lymphocytic leukemia. |
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On February 18, 2010, Biogen Idec and Swedish Orphan Biovitrum announced that they
restructured the collaboration agreement for the companies long-acting, recombinant
Factor VIII Fc fusion protein (rFVIIIFc) in hemophilia A patients and the recombinant
Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. |
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Under the amended agreement, Biogen Idec will assume full development responsibilities and
costs, as well as manufacturing rights for the rFVIIIFc and rFIXFc programs. Biogen Idec
also gains marketing responsibility for the rest-of-world territories that had previously
been shared between the two companies, in addition to its existing commercial rights in
North America. Swedish Orphan Biovitrum will retain commercial rights in Europe, Russia,
Turkey and the Middle East. The cross-royalty rate has been reduced for both companies. The
royalty rates could be further adjusted when Biogen Idecs increased costs are reimbursed. |
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In January 2010, we initiated patient enrollment in a registrational study for
long-acting recombinant Factor IX in hemophilia B, known as B-LONG. The initiation of this
study resulted in the achievement of a milestone, obligating us to pay $40.0 million to
the former shareholders of Syntonix. We recorded this payment as acquired in-process
research and development expense during the first quarter of 2010. |
Page 5 Biogen Idec Reports First Quarter 2010 Results
Conference Call and Webcast
Biogen Idecs earnings conference call for the first quarter will be broadcast via the Internet at
8:30 a.m. ET on April 20, 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 May 21, 2010.
About TYSABRI
TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of
MS and in the European Union for relapsing-remitting MS.
Data from the Phase 3 AFFIRM trial highlights TYSABRIs powerful efficacy. According to that data,
which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led
to a 68% relative reduction (p<0.001) in the annualized relapse rate when compared with placebo
and reduced the relative risk of disability progression by 42-54% (p<0.001). In post-hoc
analyses of the Phase 3 AFFIRM trial and as published in The Lancet Neurology, 37% of
TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures,
compared to seven percent of placebo-treated patients.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic
viral infection of the brain. The risk of PML increases with increasing duration of use with
limited experience beyond three years of treatment. Other serious adverse events that have occurred
in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections,
including opportunistic and other atypical infections. Clinically significant liver injury has been
reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events
reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary
tract infections, joint and limb pain and rash.
TYSABRI is co-marketed by Biogen Idec and Elan Pharmaceuticals, Inc. For more information about
TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About AVONEX
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide, with nearly
140,000 patients on therapy. It is used worldwide as a treatment for relapsing forms of MS to slow
the progression of physical disability and reduce relapses. AVONEX is also approved for patients
who have their first clinical MS attack and have a brain MRI scan consistent with MS.
The most common side effects associated with AVONEX MS treatment are flu-like symptoms, including
myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
Page 6 Biogen Idec Reports First Quarter 2010 Results
AVONEX should be used with caution in patients with depression or other mood disorders and in
patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac
disease should be closely monitored. Patients should also be monitored for signs of hepatic injury.
Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX.
Rare cases of anaphylaxis have been reported. Please see complete prescribing information available
at www.axonex.com.
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 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 TYSABRIs sales growth,
competitive pressures, 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, 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, charges and other costs relating to our properties, fluctuations in our
effective tax rate, our ability to attract and retain qualified personnel, the risks of doing
business internationally, proxy contests and representation of activist shareholders on our board
of directors, our ability to protect our intellectual property rights and the cost of doing so,
product liability claims, fluctuations in our operating results, 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 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.
March 31, 2010
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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2010 |
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2009 |
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REVENUES |
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Product |
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$ |
824,220 |
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$ |
733,409 |
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Unconsolidated joint business |
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254,928 |
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278,818 |
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Royalties |
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26,023 |
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24,083 |
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Corporate partner |
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3,689 |
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174 |
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Total revenues |
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1,108,860 |
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1,036,484 |
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COST AND EXPENSES |
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Cost of sales |
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97,055 |
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98,197 |
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Research and development |
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307,030 |
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279,478 |
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Selling, general and administrative |
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248,664 |
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221,830 |
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Amortization of acquired intangible assets |
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48,889 |
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89,248 |
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Collaboration profit sharing |
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63,557 |
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42,773 |
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Acquired in-process research and development |
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39,976 |
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Total cost and expenses |
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805,171 |
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731,526 |
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Income from operations |
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303,689 |
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304,958 |
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Other (expense), income net |
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(8,386 |
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6,846 |
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INCOME BEFORE INCOME TAX EXPENSE |
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295,303 |
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311,804 |
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Income tax expense |
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75,310 |
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65,225 |
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NET INCOME |
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$ |
219,993 |
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$ |
246,579 |
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Less: Net income attributable to noncontrolling
interest, net of tax |
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2,551 |
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2,592 |
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NET INCOME ATTRIBUTABLE TO BIOGEN IDEC INC. |
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$ |
217,442 |
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$ |
243,987 |
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BASIC EARNINGS PER SHARE |
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$ |
0.80 |
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$ |
0.85 |
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DILUTED EARNINGS PER SHARE |
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$ |
0.80 |
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$ |
0.84 |
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WEIGHTED-AVERAGE SHARES USED IN CALCULATING: |
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BASIC EARNINGS PER SHARE |
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269,922 |
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287,703 |
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DILUTED EARNINGS PER SHARE |
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272,703 |
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289,744 |
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TABLE 2
Biogen Idec Inc.
March 31, 2010
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
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March 31, |
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December |
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2010 |
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31, 2009 |
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ASSETS |
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Cash, cash equivalents and marketable securities |
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$ |
1,152,674 |
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$ |
1,263,724 |
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Accounts receivable, net |
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560,777 |
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551,208 |
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Inventory |
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280,038 |
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293,950 |
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Other current assets |
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415,523 |
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371,713 |
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Total current assets |
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2,409,012 |
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2,480,595 |
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Marketable securities |
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1,032,223 |
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1,194,080 |
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Property, plant and equipment, net |
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1,604,573 |
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1,637,083 |
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Intangible assets, net |
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1,822,133 |
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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 |
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210,761 |
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230,397 |
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TOTAL ASSETS |
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$ |
8,217,323 |
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$ |
8,551,854 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current portion of notes payable and line of credit |
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$ |
19,115 |
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$ |
19,762 |
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Other current liabilities |
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|
663,215 |
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|
695,180 |
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Long-term deferred tax liability |
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|
248,898 |
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|
240,618 |
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Notes payable |
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|
1,076,201 |
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|
1,080,207 |
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Other long-term liabilities |
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|
259,300 |
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|
|
254,205 |
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Shareholders equity |
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5,950,594 |
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|
|
6,261,882 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
8,217,323 |
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$ |
8,551,854 |
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TABLE 3
Biogen Idec Inc.
March 31, 2010
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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EARNINGS PER SHARE |
|
2010 |
|
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2009 |
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GAAP earnings per share Diluted |
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$ |
0.80 |
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$ |
0.84 |
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Adjustments to net income
attributable to Biogen Idec Inc. (as
detailed below) |
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0.28 |
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0.21 |
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Non-GAAP earnings per share Diluted |
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$ |
1.08 |
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$ |
1.05 |
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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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$ |
217.4 |
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$ |
244.0 |
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Adjustments: |
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R&D: Restructuring and severance |
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0.6 |
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1.0 |
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R&D: Stock option expense |
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1.6 |
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2.2 |
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R&D: Expenses paid by Cardiokine |
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1.8 |
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1.6 |
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SG&A: Restructuring and severance |
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4.3 |
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0.1 |
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SG&A: Stock option expense |
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10.8 |
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4.5 |
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Amortization of acquired intangible assets |
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48.9 |
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89.2 |
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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 primarily related to reconciling items |
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(27.2 |
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(35.4 |
) |
Noncontrolling interest: Expenses paid by Cardiokine |
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(1.8 |
) |
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(1.6 |
) |
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Non-GAAP net income attributable to Biogen Idec Inc. |
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$ |
296.4 |
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$ |
305.6 |
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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, 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 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 also exclude stock option expense from our non-GAAP
R&D expenses and SG&A expenses, but include 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.
March 31, 2010
Product Revenues
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
PRODUCT REVENUES |
|
|
|
|
|
|
|
|
Avonex® |
|
$ |
592,527 |
|
|
$ |
555,289 |
|
Tysabri® |
|
|
218,643 |
|
|
|
165,205 |
|
Fumaderm® |
|
|
13,050 |
|
|
|
10,585 |
|
Other |
|
|
|
|
|
|
2,330 |
|
|
|
|
|
|
|
|
Total product revenues |
|
$ |
824,220 |
|
|
$ |
733,409 |
|
|
|
|
|
|
|
|