Biogen Idec Delivers Double-Digit Top & Bottom-Line Growth in Second Quarter 2013

  Biogen Idec Delivers Double-Digit Top & Bottom-Line Growth in Second Quarter
  2013

      -- Strong Start for TECFIDERA^® (Dimethyl Fumarate) in the U.S. --

          -- Three Potential Product Launches Planned for in 2014 --

               -- Company Increases 2013 Financial Guidance --

Business Wire

WESTON, Mass. -- July 25, 2013

Biogen Idec Inc. (NASDAQ: BIIB) today reported second quarter 2013 total
revenues of $1.7 billion, an increase of 21% compared to the second quarter of
2012. Non-GAAP diluted EPS for the second quarter of 2013 were $2.30, an
increase of 26% over the second quarter of 2012. Non-GAAP net income
attributable to Biogen Idec for the second quarter of 2013 was $549 million,
an increase of 25% versus the second quarter of 2012.

Second quarter of 2013 GAAP diluted EPS were $2.06, an increase of 28% versus
the second quarter of 2012. GAAP net income for the second quarter of 2013 was
$491 million, an increase of 27% versus the second 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^® revenues increased 2% year-over-year to $774 million. The total
    was comprised of $479 million in U.S. sales and $295 million in sales
    outside the U.S.
  *TYSABRI^® (natalizumab) revenues for the Company increased 38%
    year-over-year to $387 million primarily due to our acquisition of Elan’s
    rights in TYSABRI as Biogen Idec started booking 100% of TYSABRI revenues.
    Global in-market sales of TYSABRI in the second quarter of 2013 were $387
    million, a decrease of 2% over the second quarter of 2012, when compared
    to TYSABRI global in-market sales in the second quarter of 2012. The total
    was comprised of $218 million in U.S. sales and $169 million in sales
    outside the U.S.
  *TECFIDERA revenues were $192 million during the second quarter. This
    revenue includes both patient demand and wholesalers and specialty
    pharmacy inventory in anticipation of patient demand. We estimate that
    approximately $82 million of TECFIDERA revenues in the second quarter
    represent inventory in the channel while revenue generated from underlying
    patient demand was approximately $110 million.
  *RITUXAN^® (rituximab) revenues from our unconsolidated joint business
    arrangement were $289 million for the quarter, an increase of 1% compared
    to the second quarter of 2012.

“With a strong start for TECFIDERA in the U.S., as well as approvals in Canada
and Australia, we expanded our leadership position in the treatment of
multiple sclerosis,” said George A. Scangos, Ph.D., Chief Executive Officer.
“With three regulatory filings completed, three potential launches in 2014,
and data readouts expected in 2015 and 2016, we have entered a new era of
growth for the benefit of patients, clinicians and our shareholders.”

Other Financial Highlights

  *Earlier this month, we agreed in principle with the pricing committee of
    the Italian National Medicines Agency to settle all prior year claims
    related to an ongoing pricing dispute. As a result, the Company recorded a
    reduction to TYSABRI revenues outside the U.S. of approximately $20
    million for a portion of this settlement. The remaining portion of the
    settlement is expected to be recorded as an increase to TYSABRI revenue
    upon approval of the settlement by the Italian authorities.
  *Revenues for FAMPYRA^® and FUMADERM™ totaled $33 million in the second
    quarter of 2013, compared to $34 million in the second quarter of 2012.
  *Royalties were $38 million in the second quarter of 2013, compared to $37
    million in the second quarter of 2012.
  *Corporate partner revenues in the second quarter of 2013 were $11 million,
    compared to $22 million in the second quarter of 2012.
  *As of June 30, 2013, Biogen Idec had Cash, Cash Equivalents and Marketable
    Securities totaling $775 million.

2013 Financial Guidance

Biogen Idec increased its full year 2013 financial guidance. This guidance
consists of the following components:

  *Revenue growth is expected to be approximately 22% to 23%.
  *Cost of Sales is expected to be approximately 13% to 14% of total revenue.
  *R&D expense is expected to be approximately 21% to 23% of total revenue.
  *R&D expense includes up to $75 million earmarked for potential new
    business development deals and assumes up to $35 million in anticipated
    upfront and milestone payments over the balance of the year.
  *SG&A expense is expected to be approximately 24% to 26% of total revenue.
  *Tax expense is expected to be approximately 22% to 24% of pretax income.
  *Non-GAAP diluted EPS is expected to be between $8.25 and $8.50.
  *GAAP diluted EPS is expected to be between $7.28 and $7.53.
  *Capital expenditures are expected to be in the range of $250 to $270
    million.

Biogen Idec may incur charges, realize gains or experience other events in
2013 that could cause actual results to vary from this guidance.

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, and we launched in the U.S. in early April 2013.

TECFIDERA recently received product approval in Australia from the Therapeutic
Goods Administration (TGA) and approval in Canada from Health Canada.

On May 29, 2013, Biogen Idec announced it was granted a European patent that
extends until 2028 and covers the expected EU TECFIDERA label dose of 480 mg.
The Company also announced an expected delay to the launch of TECFIDERA in the
EU as it continues to work to make TECFIDERA regulatory data protection
clearer to all parties prior to approval from the European Medicines Agency
(EMA).

TYSABRI (natalizumab)

On April 2, 2013, Biogen Idec completed its acquisition of full ownership of,
and strategic, commercial and decision-making rights to, TYSABRI from Elan
Pharma International, Ltd., an affiliate of Elan Corporation.

In June 2013, Biogen Idec submitted a Biologics License Application (BLA) for
the marketing approval of TYSABRI with the Pharmaceuticals and Medical Devices
Agency (PMDA) in Japan. Based on the filing’s priority review, the Company is
planning for potential marketing and pricing approval, and anticipated
commercial launch of TYSABRI in Japan in 2014.

During the second quarter, Biogen Idec also completed enrollment of ASCEND, an
important clinical trial using TYSABRI designed to help address a critical
unmet need in secondary progressive multiple sclerosis (SPMS). SPMS represents
a significant portion of the total MS patient population and there are
currently no effective therapies. Data are expected in 2015.

Recently, the FDA and EMA approved the manufacture of TYSABRI at our
large-scale manufacturing facility in Hillerød, Demark. The site is now a
licensed manufacturing facility capable of producing TYSABRI for patients who
live outside the United States. The site will also act as a back-up to our
Research Triangle Park manufacturing facility in North Carolina for supply of
TYSABRI.

AVONEX (interferon beta-1a)

AVONEX remains one of the most prescribed treatments for relapsing forms of MS
worldwide and continued to gain market share during the second quarter within
the injectable segment of the MS market.

Additional Pipeline Development Highlights

During the second quarter, Biogen Idec achieved a number of milestones toward
the development of its research and late-stage pipeline:

  *In May 2013, Biogen Idec announced it submitted a BLA to the FDA for
    approval of PLEGRIDY™ (peginterferon beta-1a), the Company’s pegylated
    subcutaneous injectable candidate for relapsing forms of multiple
    sclerosis. In June 2013, Biogen Idec also submitted a Marketing
    Authorisation Application for PLEGRIDY to the EMA. Both filings have been
    accepted by the respective regulatory authorities and the Company
    anticipates approval and commercial launch in mid-2014.
  *In May 2013, Biogen Idec also announced that the FDA accepted the
    Company’s BLA for the marketing approval of ELOCTATE™ (recombinant factor
    VIII Fc fusion protein) for the treatment of hemophilia A. ELOCTATE is the
    first hemophilia A product candidate in a new class of long-lasting
    clotting factor therapies being developed with the goal of providing
    long-lasting protection and reducing the burden of treatment for patients
    with this chronic condition. The Company anticipates a second quarter 2014
    approval and commercial launch of ELOCTATE in the United States.
  *In June and July 2013, Biogen Idec showcased new data from a number of
    development and early-stage research programs at the XXIV International
    Society on Thrombosis and Haemostasis (ISTH) Congress. Researchers
    presented 33 abstracts and 10 presentations on clinical and pre-clinical
    research in hemophilia, the breadth of which reflects the Company’s
    commitment to innovation and the scientific advancement of hemophilia
    treatment and care. Data presented included new analyses of the phase 3
    A-LONG study of ELOCTATE and B-LONG study of ALPROLIX™, results of which
    add to the growing body of evidence supporting the potential efficacy and
    safety of these long-lasting clotting factor candidates for the treatment
    of hemophilia A and B. The ISTH Congress was held from June 29 through
    July 4 in Amsterdam, The Netherlands.

Conference Call and Webcast

The Company's earnings conference call for the second quarter will be
broadcast via the internet at 8:00 a.m. EDT on July 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.

Safe Harbor

This press release contains forward-looking statements, including statements
about 2013 financial guidance, potential product launches and timing thereof,
regulatory actions, anticipated clinical trial data readouts, and the
commercialization and impact of 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 sales from our four principal products, AVONEX,
TECFIDERA, TYSABRI and RITUXAN; failure to protect and enforce our data,
intellectual property and other proprietary rights and the diminution of our
ability to derive anticipated benefits from our products; uncertainty of
success in executing our commercial launch of TECFIDERA and 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 other third parties over which we may not always have full
control; problems with our manufacturing processes, limitation in our capacity
and our reliance on third parties; failure to comply with government
regulation; 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; uncertainty and potential liabilities relating
to product liability and intellectual property claims; the market, interest
and credit risks associated with our portfolio of marketable securities;
environmental risks; 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)
                                                                
                                                                         
                     For the Three Months              For the Six Months
                     Ended June 30,                    Ended June 30,
                     2013              2012            2013              2012
Revenues:
                                                                         
Product, net         $ 1,385,918       $ 1,076,800     $ 2,481,697       $ 2,052,288
                                                                         
Unconsolidated         288,785           284,630         553,391           569,183
joint business
                                                                         
Royalty                38,111            37,084          70,931            65,884
                                                                         
Corporate             10,659          22,437         32,550          25,611
partner
                                                                         
Total revenues        1,723,473       1,420,951      3,138,569       2,712,966
                                                                         
Cost and
expenses:
                                                                         
Cost of sales,
excluding
amortization of        230,728           139,112         364,477           272,308
acquired
intangible
assets
                                                                         
Research and           327,463           329,559         611,803           685,521
development
                                                                         
Selling, general
and                    431,012           301,767         783,610           601,856
administrative
                                                                         
Amortization of
acquired               82,225            52,282          133,526           98,243
intangible
assets
                                                                         
Collaboration          -                 78,511          85,357            164,406
profit sharing
                                                                         
(Gain) Loss on
Fair Value
Remeasurement of       (5,163    )       12,858          (2,886    )       14,117
Contingent
Consideration
                                                                         
Restructuring         -               1,139          -               1,422
charge
                                                                         
Total cost and        1,066,265       915,228        1,975,887       1,837,873
expenses
                                                                         
Gain on sale of       5,319           -              10,370          -
rights
                                                                         
Income from            662,527           505,723         1,173,052         875,093
operations
                                                                         
Other income          (10,428   )      2,950          (24,885   )      18,094
(expense), net
                                                                         
Income before
income tax
expense and            652,099           508,673         1,148,167         893,187
equity in loss
of investee, net
of tax
                                                                         
Income tax             159,140           121,021         224,648           203,169
expense
                                                                         
Equity in loss
of investee, net      2,289           511            6,100           511
of tax
                                                                         
Net income             490,670           387,141         917,419           689,507
                                                                         
Net income
attributable to
non-controlling       -               295            -               -
interests, net
of tax
                                                                         
Net income
attributable to      $ 490,670        $ 386,846       $ 917,419        $ 689,507
Biogen Idec Inc.
                                                                         
                                                                         
Net income per
share:
Basic earnings
per share            $ 2.07           $ 1.62          $ 3.87           $ 2.88
attributable to
Biogen Idec Inc.
                                                                         
Diluted earnings
per share            $ 2.06           $ 1.61          $ 3.85           $ 2.86
attributable to
Biogen Idec Inc.
                                                                         
                                                                         
Weighted-average
shares used in
calculating:
Basic earnings
per share             237,484         238,988        237,162         239,389
attributable to
Biogen Idec Inc.
                                                                         
Diluted earnings
per share             238,743         240,622        238,543         241,245
attributable to
Biogen Idec Inc.
                                                                           

TABLE 2
Biogen Idec Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(unaudited, in thousands)
                                                             
                                                 As of            As of
                                                 June 30,         December 31,
                                                 2013             2012
ASSETS
                                                                  
                                                                  
Cash, cash equivalents and marketable            $ 667,670        $ 1,705,710
securities
                                                                  
Accounts receivable, net                           861,457          686,848
                                                                  
Inventory                                          570,390          447,373
                                                                  
Other current assets                              423,704         404,406
                                                                  
Total current assets                               2,523,221        3,244,337
                                                                  
Marketable securities                              107,139          2,036,658
                                                                  
Property, plant and equipment, net                 1,787,776        1,742,226
                                                                  
Intangible assets, net                             4,678,884        1,631,547
                                                                  
Goodwill                                           1,210,718        1,201,296
                                                                  
Investments and other assets                      533,852         274,054
                                                                  
TOTAL ASSETS                                     $ 10,841,590     $ 10,130,118
                                                                  
                                                                  
LIABILITIES AND EQUITY
                                                                  
Current portion of notes payable and line of     $ 3,188          $ 453,379
credit
                                                                  
Other current liabilities                          1,300,886        1,204,010
                                                                  
Notes payable and other financing                  726,388          687,396
arrangements
                                                                  
Long-term deferred tax liability                   313,341          217,272
                                                                  
Other long-term liabilities                        595,642          604,266
                                                                  
Equity                                            7,902,145       6,963,795
                                                                  
TOTAL LIABILITIES AND EQUITY                     $ 10,841,590     $ 10,130,118
                                                                    

TABLE 3
Biogen Idec Inc. and Subsidiaries
GAAP to Non-GAAP Reconciliation: Net Income and Net Income Per Share
(unaudited, in millions, except per share amounts)
                                                            
                                                                     
                       For the Three Months           For the Six Months
                       Ended June 30,                 Ended June 30,
EARNINGS PER           2013             2012          2013           2012
SHARE
                                                                     
GAAP earnings
per share -            $  2.06          $ 1.61        $ 3.85         $ 2.86
Diluted
Adjustments to
net income
attributable to          0.24          0.21        0.42         0.36  
Biogen Idec Inc.
(as detailed
below)
Non-GAAP
earnings per           $  2.30         $ 1.82       $ 4.27        $ 3.22  
share - Diluted
                                                                     
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        $  490.7         $ 386.8       $ 917.4        $ 689.5
Biogen Idec Inc.
Adjustments:
Amortization of
acquired                  79.5            51.0          128.1          94.3
intangible
assets
(Gain) Loss on
Fair Value
Remeasurement of          (5.2   )        12.9          (2.9    )      14.1
Contingent
Consideration
SG&A: Stock               1.0             0.9           2.9            1.4
option expense
R&D: Stock                0.8             0.5           2.4            1.6
option expense
R&D:
Restructuring             -               -             -              1.3
and other
2010
Restructuring             -               1.1           -              1.4
initiatives
Non-controlling           -               0.3           -              -
interests
Income tax
effect related           (18.0  )       (14.4 )      (29.7   )     (26.1 )
to reconciling
items
Non-GAAP net
income                 $  548.8        $ 439.1      $ 1,018.2     $ 777.5 
attributable to
Biogen Idec Inc.
                                                                     
                                                                     
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:
                                                                     
                       $                Shares        Diluted EPS
Projected GAAP
net income             $  1,767           239         $ 7.40
attributable to
Biogen Idec Inc.
Adjustments:
Stock option              8
expense
Restructuring             -
and other
Amortization of
acquired                  287
intangible
assets
(Gain) Loss on
Fair Value
Remeasurement of          5
Contingent
Consideration
Income tax
expense: Income
tax effect               (67    )                   
related to
reconciling
items
Projected
Non-GAAP net
income                 $  2,000         239        $ 8.38    
attributable to
Biogen Idec Inc.
                                                                     

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
acquisition 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 fair value
remeasurements 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.

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)
                                      
                                           
                           For the Three Months
                           Ended June 30,
                           2013            2012
PRODUCT REVENUES
                                           
AVONEX®                    $ 774,416       $ 762,065
                                           
TYSABRI®                     386,741         280,423
                                           
TECFIDERA®                   192,134         -
                                           
FAMPYRA®                     16,811          19,681
                                           
FUMADERM™                    15,816          14,631
                                          
Total product revenues     $ 1,385,918     $ 1,076,800
                                           
                                           
                           For the Six Months
                           Ended June 30,
                           2013            2012
PRODUCT REVENUES
                                           
AVONEX®                    $ 1,520,514     $ 1,423,684
                                           
TYSABRI®                     698,911         565,956
                                           
TECFIDERA®                   192,134         -
                                           
FAMPYRA®                     40,014          34,721
                                           
FUMADERM™                    30,124          27,927
                                          
Total product revenues     $ 2,481,697     $ 2,052,288
                                           

Contact:

Biogen Idec Media Contact:
Biogen Idec
Daniel McIntyre, 781-464-3260
Senior Vice President, Public Affairs
or
Biogen Idec Investor Contacts:
Biogen Idec
Ben Strain, 781-464-2442
Senior Manager, Investor Relations
or
Biogen Idec
Claudine Prowse, Ph.D., 781-464-2442
Vice President, Investor Relations
 
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