1/16
`
`Biogen Idec Total Revenues Increased 10% to $1.4 Billion in First
`Quarter 2013
`investors.biogen.com/news-re eases/news-re ease-deta s/b ogen- dec-tota -revenues- ncreased-10-14-b on-f rst-quarter
`
`April 25, 2013 at 6:30 AM EDT
`
`-- First Quarter Non-GAAP Diluted EPS Rose 41% and GAAP Diluted EPS Up 43% --
`
`-- TECFIDERA™ (Dimethyl Fumarate) Approved and Launched in the US as a First-Line Oral Treatment
`for Relapsing Forms of Multiple Sclerosis; EU Approval Pending --
`
`-- Gained Full Strategic, Commercial and Decision-Making Rights to TYSABRI
`
`®
` --
`
`WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec Inc. (NASDAQ: BIIB) today reported first quarter
`2013 total revenues of $1.4 billion, an increase of 10% compared to the first quarter of 2012.
`Non-GAAP diluted EPS for the first quarter of 2013 were $1.97, an increase of 41% over the first
`quarter of 2012. Non-GAAP net income attributable to Biogen Idec for the first quarter 2013 was
`$469 million, an increase of 39% versus the first quarter of 2012.
`
`First quarter 2013 GAAP diluted EPS were $1.79, an increase of 43% versus the first quarter of
`2012. GAAP net income for the first quarter was $427 million, an increase of 41% versus the first
`quarter of 2012. A reconciliation of our GAAP to Non-GAAP results is attached to this press
`release.
`
`®
`Revenue gains were led by the performance of our marketed therapies: AVONEX (interferon
`beta-1a) with revenues increasing 13% year-over-year to $746 million; and TYSABRI
`(natalizumab) with revenues increasing 9% year-over-year to $312 million. RITUXAN (rituximab)
`revenues from our unconsolidated joint business arrangement were $265 million for the
`quarter, a decrease of 7% from the prior year.
`
`® ®
`
`“2013 is off to an exciting start for Biogen Idec and the patients we serve,” said George A.
`Scangos, Ph.D., Chief Executive Officer. “We achieved several milestones that expand our
`TM
`leadership in supporting people living with MS, including the launch of TECFIDERA (dimethyl
`fumarate) in the US, acquisition of full rights and control of TYSABRI and a positive phase 3 trial
`TM
`for PLEGRIDY
`(Peginterferon beta-1a) in the treatment of relapsing-remitting multiple
`sclerosis.”
`
`“We also are preparing for the potential launches in 2014 of our long-lasting clotting factor
`therapies for hemophilia, rFVIIIFc and rFIXFc,” he continued. “We believe these therapies have
`the potential to transform the standard of care for hemophilia patients around the world. Our
`entire organization is aligned behind our focused mission and executing well in every aspect of
`the business – from launching new products to advancing our deep early-stage pipeline.”
`
`Other Financial Highlights
`
`Biogen Exhibit 2134
`Mylan v. Biogen
`IPR2018-01403
`
`Page 1 of 16
`
`

`

`During the first quarter of 2013, we received updated technical guidance from the IRS
`concerning our U.S. federal manufacturing deduction related to our unconsolidated joint
`business. Based on this guidance, we reevaluated our manufacturing deduction and
`recorded a $33 million benefit, which is net of ancillary federal and state tax effects,
`related to the years 2005 through 2012, in the first quarter of 2013. We also experienced
`modest favorability due to the reinstatement of the federal R&D tax credit and the award
`of a state life science tax credit. As a result, Biogen Idec benefited from low GAAP and non-
`GAAP tax rates of 13.2% and 14.0%, respectively. These unusually low tax rates benefited
`our non-GAAP EPS by approximately $0.17 and GAAP EPS by approximately $0.16.
`Our share of RITUXAN revenues from our unconsolidated joint business was reduced by
`approximately $42 million during the first quarter of 2013 as a result of damages awarded
`against Genentech in its arbitration with Hoechst GmbH.
`®
`Revenues for FAMPYRA and FUMADERM™ totaled $38 million in the first quarter of 2013,
`compared to $28 million in the first quarter of 2012.
`Royalties were $33 million in the first quarter of 2013, an increase of 14% compared to the
`first quarter of 2012.
`Corporate partner revenues in the first quarter of 2013 were $22 million, compared to $3
`million in the first quarter of 2012.
`As of March 31, 2013, Biogen Idec had Cash, Cash Equivalents and a Reverse Repurchase
`Agreement totaling approximately $3.6 billion, of which we used $3.25 billion to fund our
`acquisition of TYSABRI rights from Elan on April 2, 2013.
`On April 17, 2013, Standard & Poor’s raised Biogen Idec’s credit rating to A- from BBB+
`reflecting the launch of TECFIDERA, greater TYSABRI revenue due to the close of the
`transaction with Elan, low leverage and strong and growing cash flow generation.
`
`2013 Financial Guidance
`
`Biogen Idec updated its full year 2013 financial guidance. This guidance consists of the following
`components:
`
`Revenue growth is expected to be approximately 16% to 18%.
`Cost of Sales is expected to be approximately 13% to 15% of total revenue.
`R&D expense is expected to be approximately 22% to 23% of total revenue.
`R&D expense includes up to $75 million earmarked for potential new business
`development deals.
`SG&A expense is expected to be approximately 24% to 26% of total revenue.
`Tax expense is expected to be approximately 22% to 23% of pretax income.
`Non-GAAP diluted EPS is expected to be between $7.80 and $7.90.
`GAAP diluted EPS is expected to be between $6.69 and $6.79.
`Capital expenditures are expected to be in the range of $250 to $270 million.
`Company anticipates an ending 2013 cash balance greater than $1 billion, of which the
`majority will be located in the U.S.
`
`2/16
`
`Page 2 of 16
`
`

`

`Biogen Idec may incur charges, realize gains or experience other events in 2013 that could cause
`actual results to vary from this guidance.
`
`“In the first quarter, we continued to drive solid performance while making substantial progress
`moving our late-stage programs towards approvals and launch,” said Paul J. Clancy, Executive
`Vice President and Chief Financial Officer. “Notably, we delivered solid EPS growth, continued to
`make disciplined R&D investments, focused on building our MS franchise, and were able to
`increase our outlook for the year. We expect to continue our strong performance throughout
`2013.”
`
`Multiple Sclerosis (MS) Franchise Highlights
`
`TECFIDERA (dimethyl fumarate)
`
`The U.S. Food and Drug Administration’s (FDA) approved TECFIDERA on March 27, 2013, as a
`new first-line oral treatment for people living with relapsing forms of MS. TECFIDERA is now
`available to MS patients across the United States.
`
`On March 22, 2013, the Committee for Medicinal Products for Human Use (CHMP) issued a
`positive opinion recommending that the European Commission (EC) provide marketing
`authorization for TECFIDERA in the European Union as a first-line oral treatment for adults with
`relapsing-remitting multiple sclerosis (RRMS). The EC decision on TECFIDERA is expected in the
`second quarter of 2013.
`
`On March 19, 2013, the U.S. Patent and Trademark Office issued a patent for the TECFIDERA
`dosing regimen of 480 mg daily. This patent, which expires in 2028, adds to the growing
`portfolio of patents covering TECFIDERA. The European Patent Office also recently determined
`that Biogen Idec’s application for a patent covering the same dosing regimen of TECFIDERA is
`allowable. Once granted, this patent would also expire in 2028.
`
`TYSABRI (natalizumab)
`
`TYSABRI revenues increased 9% year-over-year to $312 million. Global in-market sales of
`TYSABRI in the first quarter of 2013 were $456 million, an increase of 15% over the first quarter
`of 2012. The total was comprised of $257 million in U.S. sales and $199 million in sales outside
`the U.S.
`
`On April 2, 2013, Biogen Idec completed its purchase of Elan’s interest in TYSABRI and gained full
`strategic, commercial and decision-making rights to the product. Biogen Idec used its cash
`resources to make a payment of $3.25 billion to Elan. Subject to the terms of the agreement
`with Elan, the Company and Elan will continue to share TYSABRI profits equally through April 30,
`2013. Commencing May 1, 2013 and for the first twelve months thereafter, the Company will
`make future contingent payments to Elan in an amount equal to 12% of global net sales of
`TYSABRI, and thereafter, Biogen Idec will continue to make contingent payments of 18% on
`
`3/16
`
`Page 3 of 16
`
`

`

`annual global net sales of TYSABRI up to $2.0 billion and 25% on annual global net sales that
`exceed $2.0 billion. In 2014 only, the $2.0 billion threshold will be pro-rated for the portion of
`2014 remaining after the completion of the first twelve months of contingent payments.
`
`On March 18, 2013, Biogen Idec and Elan announced results from several studies of TYSABRI
`that demonstrate its efficacy compared to other MS treatments, provide additional data
`supporting anti-JC virus (JCV) antibody status stability, and suggest better outcomes when
`progressive multifocal leukoencephalopathy (PML) is detected early. These data were presented
`at the 65th Annual Meeting of the American Academy of Neurology (AAN) held in San Diego, CA
`in March 2013.
`
`®
`Based on data available to us through the TOUCH prescribing program and other third-party
`sources, as of the end of March 2013, the Company estimates that approximately 73,600
`patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively,
`approximately 115,400 patients have been treated with TYSABRI in the post-marketing setting.
`
`AVONEX (interferon beta-1a)
`
`AVONEX revenues increased 13% year-over-year to $746 million. AVONEX remains one of the
`most prescribed treatments for relapsing forms of MS worldwide and continued to gain market
`share during the first quarter within the injectable segment of the MS market place. The
`AVONEX PEN® auto-injector, a dosing innovation designed to improve the treatment experience
`for patients receiving once-a-week AVONEX, has now been commercially launched in 27
`countries.
`
`Additional Pipeline Development Highlights
`
`During the first quarter Biogen Idec achieved a number of milestones toward the development
`of its hemophilia program:
`
`In March 2013, Biogen Idec submitted a Biologics License Application (BLA) to the FDA for
`the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the
`treatment of hemophilia A. Recombinant FVIIIFc is the first hemophilia A product
`candidate in a new class of long-lasting clotting factor therapies being developed with the
`goal of reducing the burden of treatment for this condition.
`On March 4, 2013, Biogen Idec announced that the FDA accepted the Company’s BLA for
`the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the
`treatment of hemophilia B and granted the Company a standard review timeline.
`On February 8, 2013, Biogen Idec and Swedish Orphan Biovitrum (Sobi) released data at
`the 6th Annual Congress of the European Association for Haemophilia and Allied
`Disorders (EAHAD) in Warsaw, Poland. Data presented confirmed the ability of
`investigational rFVIIIFc and rFIXFc to provide long-lasting protection from bleeding with
`fewer injections than are required with the current standard of care for people with
`hemophilia.
`
`4/16
`
`Page 4 of 16
`
`

`

`On January 24, 2013, Biogen Idec announced positive, full first-year results from its two-year
`pivotal Phase 3 ADVANCE study of PLEGRIDY, the Company’s investigational candidate for RRMS.
`If approved, PLEGRIDY will be dosed once every two weeks and we believe has the potential to
`be a preferred option in the injectable class of MS treatments. We will be submitting our
`regulatory applications to the FDA and EMA by mid-2013, for potential approval in 2014.
`
`During March 16 through March 23, 2013, Biogen Idec presented more than 50 company-
`sponsored platform and poster presentations on data supporting its multiple-marketed and
`pipeline therapies for neurological diseases at the AAN Annual Meeting in San Diego. Biogen
`Idec presented notable data on several programs including: TECFIDERA, TYSABRI, AVONEX,
`PLEGRIDY, daclizumab high-yield process, and anti-LINGO.
`
`On April 4, 2013, Biogen Idec announced results from the daclizumab high-yield process (DAC
`HYP) SELECT clinical trial were published in an on-line article in The Lancet. SELECT was a Phase
`2b registrational study designed to determine the efficacy and safety of DAC HYP in patients
`with RRMS.
`
`Conference Call and Webcast
`
`The Company's earnings conference call for the first quarter will be broadcast via the internet at
`8:00 a.m. EDT on April 25, 2013, and will be accessible through the Investors section of Biogen
`Idec's homepage, www.biogenidec.com. Supplemental information in the form of a slide
`presentation will also be accessible at the same location on the internet at the time of the
`conference call and will be subsequently available on the website for one month.
`
`About Biogen Idec
`
`Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to
`patients worldwide innovative therapies for the treatment of neurodegenerative diseases,
`hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest
`independent biotechnology company. Patients worldwide benefit from its leading multiple
`sclerosis therapies, and the Company generates more than $5 billion in annual revenues. For
`product labeling, press releases and additional information about the Company, please visit
`www.biogenidec.com.
`
`About AVONEX
`
`AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX
`is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of
`physical disability and decrease the frequency of clinical exacerbations. Patients with MS in
`whom efficacy has been demonstrated include patients who have experienced a first clinical
`episode and have MRI features consistent with MS.
`
`5/16
`
`Page 5 of 16
`
`

`

`Symptoms of depression, suicidal ideation, or psychosis, and cases of suicide, have been
`reported with increased frequency with patients receiving AVONEX. Severe hepatic injury,
`including cases of hepatic failure has been reported rarely in patients. Rare cases of anaphylaxis
`have been reported. While beta interferons do not have any known direct cardiac toxicity, cases
`of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure
`have been reported in patients without known predisposition. Decreased peripheral blood
`counts have been reported from postmarketing experience. Seizures have been reported in
`patients using AVONEX, including patients with no prior history of seizure. Autoimmune
`disorders of multiple target organs have been reported. Routine periodic blood chemistry,
`hematology, liver function, and thyroid function tests are recommended. There are no adequate
`and well-controlled studies in pregnant women. AVONEX should be used during pregnancy only
`if the potential benefit justifies the potential risk to the fetus. The most common side effects
`associated with AVONEX treatment are flu-like symptoms, including chills, fever, myalgia, and
`asthenia.
`
`For additional important safety information, and the full United States prescribing information,
`please see www.AVONEX.com.
`
`About TYSABRI
`
`TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a
`monotherapy for relapsing forms of MS, generally for patients who have had an inadequate
`response to, or are unable to tolerate, an alternative MS therapy due to the risk of progressive
`multifocal leukoencephalopathy (PML). In the European Union, it is approved for highly active
`RRMS in adult patients who have failed to respond to beta interferon or have rapidly evolving,
`severe RRMS.
`
`TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the
`Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that
`after two years, TYSABRI treatment led to a 68 percent 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 percent (p<0.001).
`
`TYSABRI increases the risk of PML, an opportunistic viral infection of the brain which usually
`leads to death or severe disability. Infection by the JC virus (JCV) is required for the development
`of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML.
`Factors that increase the risk of PML are presence of anti-JCV antibodies, prior
`immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three
`risk factors have the highest risk of developing PML. 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 also been reported in the post-marketing setting. A list of adverse events can be found in
`the full TYSABRI product labeling for each country where it is approved.
`
`6/16
`
`Page 6 of 16
`
`

`

`For additional important safety information, and the full TYSABRI prescribing information,
`please see www.TYSABRI.com.
`
`About TECFIDERA
`
`TECFIDERA delayed-release capsules are indicated for the treatment of patients with relapsing
`forms of MS. TECFIDERA has been proven to reduce MS relapses, progression of disability and
`MS brain lesions. The efficacy and safety of TECFIDERA has been studied in a large, global clinical
`program with more than 3,600 MS patients, which includes an ongoing long-term extension
`study. It is believed that TECFIDERA provides a new approach to treating MS by activating the
`Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way
`for cells in the body to defend themselves against inflammation and oxidative stress caused by
`conditions like MS.
`
`The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in
`nature, and GI events (i.e., diarrhea, nausea, abdominal pain). These events are most common
`at the start of therapy and usually decrease over time.
`
`TECFIDERA may decrease lymphocyte counts. Before starting treatment with TECFIDERA, a
`recent CBC (i.e., within six months) should be available. A CBC is recommended annually and as
`clinically indicated.
`
`There are no adequate and well-controlled studies in pregnant women. TECFIDERA should be
`used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
`
`For additional important safety information, and the full TECFIDERA prescribing information,
`please see www.TECFIDERA.com.
`
`Safe Harbor
`
`This press release contains forward-looking statements, including statements about potential
`product launches, 2013 financial guidance, growth prospects, regulatory submissions and
`agency actions, and the development, commercialization and therapeutic impact of new and
`potential treatments. These forward-looking statements may be accompanied by such words as
`“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
`“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, TYSABRI and RITUXAN, the importance of TYSABRI’s sales growth,
`uncertainty of success in executing our commercial launch of TECFIDERA, uncertainty of success
`in commercializing and developing other products, product competition, 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
`
`7/16
`
`Page 7 of 16
`
`

`

`other third parties over which we may not always have full control, problems with our
`manufacturing processes and our reliance on third parties, failure to comply with government
`regulation, our ability to protect our intellectual property rights and have sufficient rights to
`market our products together with the cost of doing so, the risks of doing business
`internationally, failure to manage our growth and execute our growth initiatives, charges and
`other costs relating to our properties, fluctuations in our effective tax rate, our ability to attract
`and retain qualified personnel, product liability claims, fluctuations in our operating results, the
`market, interest and credit risks associated with our portfolio of marketable securities,
`environmental risks, change of control provisions in our 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.
`
`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.
`
`TABLE 1
`
`Biogen Idec Inc. and Subsidiaries
`
`Condensed Consolidated Statements of Income
`
`(unaudited, in thousands, except per share amounts)
`
`
`
`
`
`
`
`
`
`
`
`Revenues:
`
`
`
`Product, net
`
`
`
`Unconsolidated joint business
`
`
`
`Royalty
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` For the Three Months
`
` Ended March 31,
`
` 2013
`
`
`
`
`
`
`
`
`
` $ 1,095,779
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`264,606
`
`32,820
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2012
`
`
`
`
`
`
`
`
`
` $ 975,488
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`284,552
`
`28,800
`
`
`
`
`
`
`
`8/16
`
`Page 8 of 16
`
`

`

`Corporate partner
`
`
`
`Total revenues
`
`
`
`Cost and expenses:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`21,891
`
`
`
`1,415,096
`
`133,749
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3,174
`
`
`
`1,292,014
`
`133,197
`
`
`
`Cost of sales, excluding amortization of acquired intangible
`assets
`
`
`
`Research and development
`
`
`
`Selling, general and administrative
`
`
`
`Collaboration profit sharing
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`284,340
`
`352,598
`
`85,357
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`355,962
`
`300,089
`
`85,894
`
`
`
`
`
`
`
`
`
`Amortization of acquired intangible assets
`
`
`
`Fair value adjustment of contingent consideration
`
`
`
`Restructuring charge
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`51,301
`
`2,277
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`45,961
`
`1,258
`
`283
`
`
`
`
`
`
`
`
`
`Total cost and expenses
`
`
`
`Gain on sale of rights
`
`
`
`Income from operations
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`909,622
`
`5,051
`
`510,525
`
`922,644
`
`-
`
`369,370
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`9/16
`
`Page 9 of 16
`
`

`

`Other income (expense), net
`
`
`
`Income before income tax expense and equity in loss of
`investee, net of tax
`
`
`
`Income tax expense
`
`(14,457
`
`496,068
`
`65,508
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`15,144
`
`384,514
`
`82,148
`
`
`
`
`
`
`
`
`
`Equity in loss of investee, net of tax
`
`
`
`Net income
`
`
`
`Net income (loss) attributable to non-controlling
`interests, net of tax
`
`3,811
`
`426,749
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-
`
`302,366
`
`(295
`
`
`
`
`
`)
`
`
`
`Net income attributable to Biogen Idec Inc.
`
`
`
`
`
`Net income per share:
`
`Basic earnings per share attributable to Biogen Idec Inc.
`
`
`
`Diluted earnings per share attributable to Biogen Idec Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 426,749
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 1.80
`
`
`
`
`
` $ 1.79
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 302,661
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 1.26
`
`
`
`
`
` $ 1.25
`
`
`
`
`
`
`
`
`
`
`
`Basic earnings per share attributable to Biogen Idec Inc.
`
`
`
`Diluted earnings per share attributable to Biogen Idec Inc.
`
`
`
`TABLE 2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`236,837
`
`238,304
`
`
`
`
`
`239,754
`
`241,828
`
`
`
`
`
`10/16
`
`Page 10 of 16
`
`

`

`Biogen Idec Inc. and Subsidiaries
`
`Condensed Consolidated Balance Sheets
`
`(unaudited, in thousands)
`
`
`
`
`
`
`
`
`
`ASSETS
`
`
`
`Cash, cash equivalents, reverse repurchase
`
`agreements and marketable securities
`
`
`
`Accounts receivable, net
`
`
`
`Inventory
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` As of
`
` March 31,
`
` 2013
`
`
`
`
`
`
`
`
`
` $ 3,631,302
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`753,611
`
`506,557
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` As of
`
` December 31,
`
` 2012
`
`
`
`
`
`
`
`
`
` $ 1,705,710
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`686,848
`
`447,373
`
`404,406
`
`Other current assets
`
`
`
`Total current assets
`
`
`
`Marketable securities
`
`
`
`Property, plant and equipment, net
`
`
`
`Intangible assets, net
`
`
`
`Goodwill
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`437,368
`
`5,328,838
`
`-
`
`1,736,811
`
`1,581,511
`
`1,210,718
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3,244,337
`
`2,036,658
`
`1,742,226
`
`1,631,547
`
`1,201,296
`
`11/16
`
`Page 11 of 16
`
`

`

`
`
`Investments and other assets
`
`
`
`TOTAL ASSETS
`
`
`
`
`
`LIABILITIES AND EQUITY
`
`
`
`Current portion of notes payable and line of credit
`
`
`
`Other current liabilities
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`306,839
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`274,054
`
` $ 10,164,717
`
` $ 10,130,118
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 203,317
`
`
`
`
`
`
`
`
`
`
`
`
`
`1,078,345
`
`156,667
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 453,379
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1,204,010
`
`217,272
`
`Long-term deferred tax liability
`
`
`
`Notes payable, line of credit and other financing
`arrangements
`
`
`
`Other long-term liabilities
`
`
`
`Equity
`
`
`
`TOTAL LIABILITIES AND EQUITY
`
`
`
`
`
`TABLE 3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`711,831
`
`674,951
`
`7,339,606
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`687,396
`
`604,266
`
`6,963,795
`
` $ 10,164,717
`
` $ 10,130,118
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Biogen Idec Inc. and Subsidiaries
`
`GAAP to Non-GAAP Reconciliation: Net Income and Net Income Per Share
`
`12/16
`
`Page 12 of 16
`
`

`

`(unaudited, in millions, except per share amounts)
`
`
`
`
`
`
`
`
`
`Adjustments to net income attributable to Biogen
`Idec Inc. (as detailed below)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` For the Three Months
`Ended March 31,
`
`
`
`
`
`
`
`
`
`
`
`
`
`0.18
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`0.15
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`Adjustments:
`
`Amortization of acquired intangible assets
`
`Fair value adjustment of contingent consideration
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 426.7
`
`
`
`
`
`
`
`
`
`
`
`
`
`48.6
`
`2.3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 302.7
`
`
`
`
`
`
`
`
`
`
`
`
`
`43.3
`
`1.3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`SG&A: Stock option expense
`
`R&D: Stock option expense
`
`R&D: Restructuring and other
`
`2010 Restructuring initiatives
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1.9
`
`1.6
`
`-
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`0.4
`
`1.0
`
`1.3
`
`0.3
`
`(0.3
`
`
`
`
`
`
`
`
`
`)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Non-controlling interests
`
`Income tax effect related to reconciling items
`
`Non-GAAP net income attributable to Biogen Idec
`Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-
`
`(11.7
`
`)
`
` $ 469.4
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(11.6
`
`)
`
` $ 338.4
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2013 Full Year Guidance GAAP to non-GAAP adjustments
`
`An itemized reconciliation between projected EPS on a GAAP basis and on a non-GAAP basis is as follows:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`13/16
`
`Page 13 of 16
`
`

`

`Projected GAAP net income attributable to Biogen
`Idec Inc.
`
`Adjustments:
`
`Stock option expense
`
`Restructuring and other
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 1,608
`
`
`
`
`
`
`
`
`
`
`
`
`
`8
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`239
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 6.74
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Amortization of acquired intangible assets
`
`Fair value adjustment of contingent consideration
`
`Income tax expense: Income tax effect related to
`reconciling items
`
`Projected Non-GAAP net income attributable to
`Biogen Idec Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`314
`
`16
`
`(74
`
`
`
`
`
`)
`
` $ 1,872
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $ 7.85
`
`239
`
`
`
`Use of Non-GAAP Financial Measures
`
`We supplement our consolidated financial statements presented on a GAAP basis by providing
`additional measures which may be considered “non-GAAP” financial measures under applicable
`SEC rules. We believe that the disclosure of these non-GAAP financial measures provides
`additional insight into the ongoing economics of our business and reflects how we manage our
`business internally, set operational goals and forms the basis of our management incentive
`programs. These non-GAAP financial measures are not in accordance with generally accepted
`accounting principles in the United States and should not be viewed in isolation or as a
`substitute for reported, or GAAP, net income attributable to Biogen Idec Inc. and diluted
`earnings per share.
`
`Our “Non-GAAP net income attributable to Biogen Idec Inc.” and “Non-GAAP earnings per share
`- Diluted” financial measures exclude the following items from GAAP net income attributable to
`Biogen Idec Inc. and diluted earnings per share:
`
`1. Purchase accounting and merger-related adjustments.
`
`We exclude certain purchase accounting related items associated with the acquistion of
`businesses, assets and amounts in relation to the consolidation of variable interest entities for
`which we are the primary beneficiary. These adjustments include charges for in-process
`research and development, the amortization of certain acquired intangible assets and
`adjustments to the fair value of our contingent consideration obligations. The exclusion of these
`charges provides management and investors with a supplemental measure of performance
`which the Company believes better reflects the underlying economics of the business.
`
`2. Stock option expense recorded in accordance with the accounting standard for share-based
`payments.
`
`14/16
`
`Page 14 of 16
`
`

`

`We believe that excluding the impact of expensing stock options better reflects the recurring
`economic characteristics of our business
`
`3. Other items.
`
`We evaluate other items 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 also include an adjustment to reflect the related tax effect of all
`reconciling items within our reconciliation of our GAAP to Non-GAAP net income attributable to
`Biogen Idec Inc.
`
`Numbers may not foot due to rounding.
`
`TABLE 4
`
`Biogen Idec Inc. and Subsidiaries
`
`Product Revenues
`
`(unaudited, in thousands)
`
`
`
`
`
`
`
`
`
`
`
`PRODUCT REVENUES
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` For the Three
`Months
`
` Ended March 31,
`
`
`
`
`
`
`
`
`
`
`
`
`
`2013
`
`746,098
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2012
`
` $ 661,620
`
`AVONEX®
`
`
`
`TYSABRI®
`
`
`
`FAMPYRA®
`
`
`
`FUMADERM®
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` $
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`312,170
`
`23,203
`
`14,308
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`285,532
`
`15,040
`
`13,296
`
`15/16
`
`Page 15 of 16
`
`

`

`Total product revenues
`
`
`
`
`
`
`
` $
`
`
`
`
`
`1,095,779
`
`
`
`
`
`
`
` $ 975,488
`
`
`
`
`
`
`
`16/16
`
`Page 16 of 16
`
`