Market Overview

Biogen Reports Quarterly Revenues of $3.1 Billion

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Total revenues grew 11% or 15% excluding hemophilia revenues*

GAAP diluted EPS increased 60%; Non-GAAP EPS increased 16%

Company adds new Phase 2 program in neuropsychiatry

Company invests in industry leading central nervous system antisense
oligonucleotide platform with Ionis Pharmaceuticals

Biogen Inc. (NASDAQ:BIIB) today reported first quarter 2018 financial
results, including:

  • Total revenues of $3.1 billion, an 11% increase versus the prior year
    or a 15% increase excluding hemophilia revenues*.
    • Multiple sclerosis (MS) revenues were $2.1 billion, including
      approximately $77 million in royalties on the sales of OCREVUS®.
    • Revenue growth was principally driven by SPINRAZA®,
      which contributed $364 million in global revenues, biosimilars,
      which contributed $128 million, and Other Revenues of $164 million.
  • GAAP net income and diluted earnings per share (EPS) attributable to
    Biogen Inc. of $1.2 billion and $5.54, respectively, compared to $748
    million and $3.46 in the first quarter of 2017, respectively.
    • In the first quarter of last year GAAP net income and diluted EPS
      were negatively impacted by $243 million and $1.14, net of tax,
      respectively, related to the U.S. Patent and Trademark Office
      ruling in favor of Biogen in the Company's interference proceeding
      with Forward Pharma A/S.
  • Non-GAAP net income and diluted EPS attributable to Biogen Inc. of
    $1.3 billion and $6.05, respectively, compared to $1.1 billion and
    $5.20 in the first quarter of 2017, respectively.
* In Q1 2017 Biogen completed the spin-off of its global hemophilia
business. The 15% increase in total revenues excludes all hemophilia
revenues in January 2017. Hemophilia revenues include ELOCTATE®
and ALPROLIX® product revenues as well as royalty and
contract manufacturing revenue related to Sobi.
                         
(In millions, except per share amounts)           Q1 '18 Q1 '17     Q4 '17

Q1 '18 v.
Q1 '17

Q1 '18 v.
Q4 '17

Total revenues* $ 3,131 $ 2,811 $ 3,307 11%* (5%)
 
GAAP net income# $ 1,173 $ 748 $ (297 ) 57% NMF
GAAP diluted EPS $ 5.54 $ 3.46 $ (1.40 ) 60% NMF
 
Non-GAAP net income# $ 1,282 $ 1,123 $ 1,116 14% 15%
Non-GAAP diluted EPS $ 6.05 $ 5.20 $ 5.26 16% 15%
# Net income attributable to Biogen Inc.
Note: Percent changes represented as favorable/(unfavorable)
 
  • In the fourth quarter of 2017 GAAP net income and EPS were negatively
    impacted by $1.2 billion and $5.51, respectively, due to the
    transition toll tax and re-measurement of the Company's net deferred
    tax assets related to the Tax Cuts and Jobs Act of 2017.

A reconciliation of GAAP to Non-GAAP quarterly financial results can be
found in Table 3 at the end of this press release.

"We started 2018 well with our first quarter revenues growing 11% versus
the prior year, or 15% excluding hemophilia revenues. This is in line
with our expectations," said Michel Vounatsos, Biogen's Chief Executive
Officer. "The fundamentals and resilience of our multiple sclerosis
business remained strong, while we experienced anticipated seasonality
at the beginning of the year. I believe there is significant opportunity
for the future growth of SPINRAZA worldwide as we position Biogen for
long-term leadership in spinal muscular atrophy."

"As pioneers in neuroscience, we continued to advance and expand our
portfolio of potential breakthrough treatments for areas of high unmet
need. We have added a new Phase 2 asset in our emerging growth area of
neuropsychiatry, and we meaningfully enhanced our collaboration with
Ionis to develop a new pipeline of gene-based therapies for neurological
diseases."

Revenue Highlights

(In millions)           Q1 '18     Q1 '17     Q4 '17    

Q1 '18 v.
Q1 '17

   

Q1 '18 v.
Q4 '17

Multiple Sclerosis:              
TECFIDERA® $ 987 $ 958 $ 1,076 3% (8%)
Total Interferon $ 550 $ 648 $ 645 (15%) (15%)
AVONEX® $ 451 $ 537 $ 520 (16%) (13%)
PLEGRIDY® $ 100 $ 112 $ 125 (11%) (20%)
TYSABRI® $ 462 $ 545 $ 463 (15%) (0%)
FAMPYRATM $ 24 $ 20 $ 24 19% 1%
ZINBRYTA® $ 1 $ 11 $ 12 (87%) (88%)
 
Spinal Muscular Atrophy
SPINRAZA $ 364 $ 47 $ 363 NMF 0%
 
Hemophilia*:
ELOCTATE $ $ 48

$

NMF NMF
ALPROLIX $ $ 26 $ NMF NMF
 
Other Product Revenues:
Biosimilars $ 128 $ 66 $ 122 93% 5%
FUMADERMTM $ 7 $ 10 $ 9 (28%) (21%)
                                     
Total Product Revenues: $ 2,523 $ 2,380 $ 2,712 6% (7%)
 
OCREVUS Royalties $ 77 $ $ 77 NMF (0%)
RITUXAN®/GAZYVA® Revenues $ 366 $ 341 $ 338 7% 8%
Other Revenues $ 164 $ 90 $ 180 83% (8%)
                                     
Total Revenues*           $ 3,131       $ 2,811       $ 3,307       11%*     (5%)
                                     
MS Product Revenues + OCREVUS Royalties           $ 2,101       $ 2,183       $ 2,296       (4%)     (8%)
Note: Numbers may not foot due to rounding; percent changes
represented as favorable/(unfavorable)
 
  • U.S. MS revenues in the first quarter of 2018 were negatively impacted
    by approximately $180 million due to the difference between the
    channel inventory level changes during the first quarter of 2018 and
    the fourth quarter of 2017 for TECFIDERA, AVONEX and PLEGRIDY.
  • In the first quarter of 2017 TYSABRI revenues outside the U.S.
    benefitted by approximately $45 million due to reaching an agreement
    with the Price and Reimbursement Committee of the Italian National
    Medicines Agency (AIFA) related to TYSABRI sales in prior periods.
  • In the first quarter of 2018 SPINRAZA revenues comprised $188 million
    in sales in the U.S. and $176 million in sales outside the U.S. The
    number of patients receiving SPINRAZA grew 16% in the U.S. and 56%
    outside the U.S. versus the fourth quarter of 2017. Outside the U.S.,
    SPINRAZA revenues were primarily from Germany, Japan, Italy and France.
  • Total revenues benefitted by approximately $54 million versus the
    prior year due to changes in foreign exchange rates, offset by hedging
    losses.

Expense Highlights

(In millions)           Q1 '18     Q1 '17     Q4 '17    

Q1 '18 v.
Q1 '17

   

Q1 '18 v.
Q4 '17

GAAP cost of sales           $ 446 $ 385     $ 509 (16%) 12%
Non-GAAP cost of sales $ 446 $ 385 $ 509 (16%) 12%
 
GAAP R&D $ 497 $ 423 $ 588 (17%) 15%
Non-GAAP R&D $ 497 $ 421 $ 588 (18%) 15%
 
GAAP SG&A $ 501 $ 499 $ 572 (1%) 12%
Non-GAAP SG&A $ 497 $

482

$ 554 (3%) 10%
 

Other Financial Highlights

  • For the first quarter of 2018 the Company's effective GAAP tax rate
    was 22%, and the Company's effective non-GAAP tax rate was 21%.
  • In the first quarter of 2018 Biogen repurchased approximately 0.9
    million shares of the Company's common stock for a total value of $250
    million.
  • As of March 31, 2018, Biogen had cash, cash equivalents and marketable
    securities totaling approximately $7.1 billion, and approximately $5.9
    billion in notes payable. During the first quarter of 2018 Biogen
    repatriated $3.5 billion of cash, resulting in 85% of cash, cash
    equivalents and marketable securities being held in the U.S. at the
    end of the quarter.
  • For the first quarter of 2018 the Company's weighted average diluted
    shares were 212 million.

Business Development Updates

  • In April 2018 Biogen and Ionis Pharmaceuticals Inc. (Ionis) announced
    a new ten-year exclusive collaboration agreement that leverages
    Biogen's leadership in neuroscience research and drug development with
    Ionis' leadership in antisense oligonucleotide (ASO) drug discovery to
    develop novel gene-based drug candidates for a broad range of
    neurological diseases. Under the terms of the collaboration, Biogen
    will make an upfront payment of $375 million and purchase $500 million
    of Ionis equity at a 25% cash premium, for a total expected payment of
    $1 billion. Biogen will have the option to license therapies arising
    out of this collaboration and will be responsible for their
    development and commercialization. Biogen may pay development
    milestones to Ionis of up to $125 million or $270 million, depending
    on the indication, and royalties on net sales. The transaction is
    subject to customary closing conditions, including the expiration of
    the applicable waiting period under the Hart Scott Rodino Antitrust
    Improvements Act of 1976 in the United States and is expected to close
    in the second quarter of 2018.
  • In March 2018 Biogen announced an agreement to acquire from Pfizer
    Inc. BIIB104 (formerly known as PF-04958242), and the transaction
    closed today. BIIB104 is a first-in-class, Phase 2b ready AMPA
    receptor potentiator for cognitive impairment associated with
    schizophrenia (CIAS), representing the Company's first program in
    neuropsychiatry. AMPA receptors mediate fast excitatory synaptic
    transmission in the central nervous system. BIIB104 has previously
    demonstrated an acceptable safety profile and treatment effect trends
    across key cognitive domains in Phase 1b clinical studies. The
    purchase included an upfront payment of $75 million with up to $515
    million in additional development and commercialization milestone
    payments, as well as tiered royalties in the low to mid-teen
    percentages.

Recent Events

  • This week, Biogen is presenting data from its portfolio of marketed
    treatments and clinical development programs for neurodegenerative
    diseases at the 70th annual meeting of the American Academy
    of Neurology (AAN) in Los Angeles, California. Platform and poster
    presentations are highlighting the benefits SPINRAZA provides for
    individuals with spinal muscular atrophy (SMA) across the age and
    disease spectrum, the Company's MS therapies and non-therapeutic
    research collaborations designed to elevate the care of MS and the
    Company's investigational therapies for Alzheimer's disease,
    Parkinson's disease and progressive supranuclear palsy.
  • In April 2018 Biogen's collaboration partner Applied Genetic
    Technologies Corporation announced that it has dosed the first patient
    in the Phase 1/2 clinical trial evaluating the safety and efficacy of
    an investigational AAV-based gene therapy for the treatment of
    x-linked retinitis pigmentosa.
  • In April 2018 Biogen and Samsung Bioepis announced an agreement with
    AbbVie Inc. for the commercialization of IMRALDITM, a
    biosimilar referencing HUMIRA® (adalimumab). Under terms of
    the agreement, AbbVie will grant patent licenses for the use and sale
    of IMRALDI in Europe, on a country-by-country basis. The companies
    have agreed to dismiss all pending patent litigation. Biogen expects
    to launch IMRALDI in Europe in October 2018.
  • In March 2018 Biogen initiated a Phase 1 study of BIIB095, a Nav 1.7
    inhibitor for neuropathic pain.
  • In March 2018 Biogen presented data from its portfolio of
    investigational therapies for people with neurodegenerative diseases
    at the Advances in Alzheimer's and Parkinson's Therapies (AAT-AD/PD)
    Focus Meeting in Torino, Italy. Data presented included an analysis
    from the Phase 1b PRIME study of aducanumab for early Alzheimer's
    disease demonstrating a 69% reduction from baseline in amyloid plaque
    as observed on the Centiloid Conversion scale for the 10 mg/kg
    treatment group at 54 weeks (P<0.001 versus placebo).
  • In March 2018 Biogen presented new data for SPINRAZA for the treatment
    of SMA at the Muscular Dystrophy Association (MDA) Clinical Conference
    in Arlington, Virginia. Data included new interim Phase 2 results from
    NURTURE, the ongoing open-label, single-arm study evaluating the
    efficacy and safety of SPINRAZA among pre-symptomatic infants with
    SMA. In NURTURE, all infants treated with SPINRAZA were alive, did not
    require permanent ventilation and showed improvement in motor function
    and motor milestone achievements as of July 5, 2017, compared to the
    disease's natural history. Biogen also presented a case series
    demonstrating SPINRAZA's effectiveness among teens and young adults.
  • In March 2018 Biogen and AbbVie announced the voluntary worldwide
    withdrawal of ZINBRYTA for relapsing MS. The companies believe that
    characterizing the complex and evolving benefit/risk profile of
    ZINBRYTA will not be possible going forward given the limited number
    of patients being treated.
  • In February 2018 the end of study results from CHERISH, the Phase 3
    study evaluating SPINRAZA for the treatment of individuals with
    later-onset SMA, were published in The New England Journal of
    Medicine
    . Results from CHERISH demonstrated meaningful motor
    function and upper limb improvements in individuals with later-onset
    SMA rarely seen in the natural course of the disease, which is
    typically a continued decline in motor function over time.
  • In February 2018 Biogen announced that in the Phase 2b dose-ranging
    ACTION 2 study in individuals with acute ischemic stroke (AIS),
    natalizumab did not demonstrate improvement in clinical outcomes
    compared to placebo. Both doses of natalizumab were generally
    well-tolerated and no new or important safety signals were observed.
    The results of the Phase 2b ACTION 2 study do not impact the
    benefit-risk profile of natalizumab in approved indications, including
    MS. Further development of natalizumab in AIS will not be pursued.

Conference Call and Webcast
The Company's earnings
conference call for the first quarter will be broadcast via the internet
at 8:30 a.m. ET on April 24, 2018, and will be accessible through the
Investors section of Biogen's website, www.biogen.com.
Supplemental information in the form of a slide presentation is also
accessible at the same location on the internet and will be subsequently
available on the website for at least one month.

Note about Future Earnings Releases and Calls
Starting with
the second quarter 2018 earnings release, Biogen intends to cease
publishing press releases relating to future earnings calls, earnings
releases and investor events via newswire services. The Company will
post these materials on the Investors section of Biogen's website, www.biogen.com,
and issue a statement on Twitter
(@biogen) when they become available.

About Biogen
At Biogen, our mission is clear: we are
pioneers in neuroscience. Biogen discovers, develops and delivers
worldwide innovative therapies for people living with serious
neurological and neurodegenerative diseases. One of the world's first
global biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter
Gilbert and Phillip Sharp, and today has the leading portfolio of
medicines to treat multiple sclerosis; has introduced the first and only
approved treatment for spinal muscular atrophy; and is focused on
advancing neuroscience research programs in Alzheimer's disease and
dementia, MS and neuroimmunology, movement disorders, neuromuscular
disorders, pain, ophthalmology, neuropsychiatry and acute neurology.
Biogen also manufactures and commercializes biosimilars of advanced
biologics.

We routinely post information that may be important to investors on our
website at www.biogen.com.
Follow us on social media - Twitter,
LinkedIn,
Facebook,
YouTube.

Safe Harbor
This press release contains forward-looking
statements, including statements relating to: our strategy and plans;
potential of our commercial business and pipeline programs; capital
allocation and investment strategy; clinical trials and data readouts
and presentations; regulatory filings and the timing thereof;
anticipated benefits and potential of investments, collaborations and
business development activities; and the anticipated timing to complete
certain transactions. These forward-looking statements may be
accompanied by such words as "aim," "anticipate," "believe," "could,"
"estimate," "expect," "forecast," "intend," "may," "plan," "potential,"
"possible," "will" and other words and terms of similar meaning. Drug
development and commercialization involve a high degree of risk, and
only a small number of research and development programs result in
commercialization of a product. Results in early stage clinical trials
may not be indicative of full results or results from later stage or
larger scale clinical trials and do not ensure regulatory approval. You
should not place undue reliance on these statements or the scientific
data presented.

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 principal products; failure
to compete effectively due to significant product competition in the
markets for our products; difficulties in obtaining and maintaining
adequate coverage, pricing and reimbursement for our products; the
occurrence of adverse safety events, restrictions on use with our
products or product liability claims; failure to protect and enforce our
data, intellectual property and other proprietary rights and the risks
and uncertainties relating to intellectual property claims and
challenges; uncertainty of long-term success in developing, licensing or
acquiring other product candidates or additional indications for
existing products; the risk that positive results in a clinical trial
may not be replicated in subsequent or confirmatory trials or success in
early stage clinical trials may not be predictive of results in later
stage or large scale clinical trials or trials in other potential
indications; risks associated with clinical trials, including our
ability to adequately manage clinical activities, unexpected concerns
that may arise from additional data or analysis obtained during clinical
trials, regulatory authorities may require additional information or
further studies or may fail to approve or may delay approval of our drug
candidates; risks associated with current and potential future
healthcare reforms; problems with our manufacturing processes; risks
relating to technology failures or breaches; our dependence on
collaborators and other third parties for the development, regulatory
approval and commercialization of products and other aspects of our
business, which are outside of our control; failure to successfully
execute on our growth initiatives; risks relating to management and key
personnel changes, including attracting and retaining key personnel;
risks relating to investment in and expansion of manufacturing capacity
for future clinical and commercial requirements; failure to comply with
legal and regulatory requirements; fluctuations in our effective tax
rate; the risks of doing business internationally, including currency
exchange rate fluctuations; risks related to commercialization of
biosimilars; risks related to investment in properties; the market,
interest and credit risks associated with our portfolio of marketable
securities; risks relating to stock repurchase programs; risks relating
to access to capital and credit markets; risks related to indebtedness;
environmental risks; risks relating to the sale and distribution by
third parties of counterfeit versions of our products; risks relating to
the use of social media for our business; change in control provisions
in certain of our collaboration agreements; risks relating to the
spin-off of our hemophilia business, including risks of operational
difficulties and exposure to claims and liabilities; 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 Securities and Exchange Commission.

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 INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF INCOME

(unaudited, in
millions, except per share amounts)

         

For the Three Months
Ended March 31,

2018     2017
Revenues:
Product, net $ 2,523.5 $ 2,380.1
Revenues from anti-CD20 therapeutic programs 443.2 340.6
Other 164.4   90.0  
Total revenues 3,131.1   2,810.7  
Cost and expenses:
Cost of sales, excluding amortization of acquired intangible assets 446.0 384.6
Research and development 496.7 423.4
Selling, general and administrative 501.3 498.7
Amortization of acquired intangible assets 103.9 448.5
Collaboration profit (loss) sharing 42.5 20.8
Acquired in-process research and development 10.0
Loss (gain) on fair value remeasurement of contingent consideration (5.6 ) 10.0
Restructuring charges 1.6    
Total cost and expenses 1,596.4   1,786.0  
Income from operations 1,534.7 1,024.7
Other income (expense), net (41.0 ) (38.0 )
Income before income tax expense and equity in loss of investee, net
of tax
1,493.7 986.7
Income tax expense 322.5 239.2
Equity in loss of investee, net of tax    
Net income 1,171.2 747.5
Net income (loss) attributable to noncontrolling interests, net of
tax
(1.7 ) (0.1 )
Net income attributable to Biogen Inc. $ 1,172.9   $ 747.6  
 
Net income per share:
Basic earnings per share attributable to Biogen Inc. $ 5.55   $ 3.47  
Diluted earnings per share attributable to Biogen Inc. $ 5.54   $ 3.46  
 
Weighted-average shares used in calculating:
Basic earnings per share attributable to Biogen Inc. 211.4   215.6  
Diluted earnings per share attributable to Biogen Inc. 211.7   215.9  
 
             

TABLE 2
BIOGEN INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS

(unaudited, in millions)

 
As of March 31,
2018
As of December 31,
2017
ASSETS
Cash, cash equivalents and marketable securities $ 5,916.0 $ 3,689.0
Accounts receivable, net 1,939.2 1,787.0
Inventory 890.8 902.7
Other current assets 1,449.4   1,494.6
Total current assets 10,195.4 7,873.3
Marketable securities 1,200.2 3,057.3
Property, plant and equipment, net 3,334.7 3,182.4
Intangible assets, net 3,794.5 3,879.6
Goodwill 4,907.8 4,632.5
Investments and other assets

2,657.5

 

1,027.5

TOTAL ASSETS $

26,090.1

  $

23,652.6

 
LIABILITIES AND EQUITY
Current liabilities $ 3,152.1 $ 3,368.2
Notes payable 5,929.4 5,935.0
Other long-term liabilities 2,971.1 1,751.3
Equity 14,037.5   12,598.1
TOTAL LIABILITIES AND EQUITY $ 26,090.1   $ 23,652.6
 
         

TABLE 3
BIOGEN INC. AND SUBSIDIARIES
GAAP
TO NON-GAAP RECONCILIATION:

NET INCOME ATTRIBUTABLE TO
BIOGEN INC. AND DILUTED EARNINGS PER SHARE

(unaudited,
in millions, except per share amounts)

 

An itemized reconciliation between diluted earnings per share on a
GAAP and Non-GAAP basis is as follows:

 
For the Three Months Ended
March 31, 2018     March 31, 2017     December 31, 2017
GAAP earnings per share - Diluted $ 5.54 $ 3.46     $ (1.40 )
Adjustments to GAAP net income attributable to Biogen Inc. (as
detailed below)
0.51   1.74       6.66  
Non-GAAP earnings per share - Diluted $ 6.05   $ 5.20       $ 5.26  

An itemized reconciliation between net income attributable to
Biogen Inc. on a GAAP and Non-GAAP basis is as follows:

         

 

For the Three Months Ended
March 31, 2018     March 31, 2017     December 31, 2017
GAAP net income attributable to Biogen Inc. $ 1,172.9 $ 747.6     $ (297.4 )

Adjustments:

Amortization of acquired intangible assetsA 103.9 448.5 139.8
Acquired in-process research and development 10.0
Loss (gain) on fair value remeasurement of contingent consideration (5.6 ) 10.0 1.5
Net distribution to noncontrolling interestsB 109.7
Hemophilia business separation costs 19.2
Restructuring, business transformation and other cost saving
initiatives:
2017 corporate strategy implementationC 3.8 18.5
Restructuring chargesC 1.6 0.9
Loss (gain) on equity security investments 6.4
Income tax effect related to reconciling items (11.3 ) (102.4 ) (30.5 )
Tax reformD         1,173.6  
Non-GAAP net income attributable to Biogen Inc. $ 1,281.7   $ 1,122.9       $ 1,116.1  
 
A Amortization of acquired intangible assets includes
impairment and amortization charges related to the intangible asset
associated with our U.S. and rest of world licenses to Forward
Pharma A/S' (Forward Pharma) intellectual property, including
Forward Pharma's intellectual property related to TECFIDERA. In
exchange for these licenses, we paid Forward Pharma $1.25 billion in
cash.

We have two intellectual property disputes with Forward Pharma,
one in the U.S. and one in the European Union, concerning
intellectual property related to TECFIDERA. In March 2017 the U.S.
intellectual property dispute was decided in our favor. We
evaluated the recoverability of the U.S. asset acquired from
Forward Pharma and recorded an impairment charge in the first
quarter of 2017 to adjust the carrying value of the acquired U.S.
asset to fair value reflecting the impact of the developments in
the U.S. legal dispute. In March 2018 the European Patent Office
issued its decision revoking Forward Pharma's European Patent No.
2 801 355. Based upon our assessment of these rulings, we continue
to amortize the remaining net book value of the U.S. and rest of
world intangible assets in our condensed consolidated statements
of income utilizing an economic consumption model.

B Net distribution to noncontrolling interests for the
three months ended December 31, 2017, reflects the after-tax
$150.0 million upfront payment made to Neurimmune SubOne AG
(Neurimmune) in exchange for a 15% reduction in royalty rates
payable on potential commercial sales of aducanumab. This upfront
payment is in relation to the amendment of terms of our
collaboration agreement with Neurimmune.

C 2017 corporate strategy and restructuring charges are
related to our efforts to create a leaner and simpler operating
model.

D On December 22, 2017, the Tax Cuts and Jobs Act of
2017 (the 2017 Tax Act) was signed into law and has resulted in
significant changes to the U.S. corporate income tax system. The
2017 Tax Act includes a federal statutory rate reduction from 35
percent to 21 percent, the elimination or reduction of certain
domestic deductions and credits, the transition of U.S.
international taxation from a worldwide tax system towards a
territorial tax system, limitations on the deductibility of
interest expense and executive compensation and base-erosion
prevention measures on future non-U.S. earnings of U.S. entities,
which has the effect of subjecting certain of our earnings of
foreign subsidiaries to U.S. taxation. These changes became
effective beginning in 2018.

The 2017 Tax Act also required a one-time mandatory deemed
repatriation tax on accumulated foreign subsidiaries' previously
untaxed foreign earnings (the Transition Toll Tax). Changes in tax
rates and tax laws are accounted for in the period of enactment.
Therefore, during the three months ended December 31, 2017, we
recorded a charge totaling $1,173.6 million related to our current
estimate of the provisions of the 2017 Tax Act, including a $989.6
million expense under the Transition Toll Tax. The Transition Toll
Tax must be paid over an eight-year period, starting in 2018, and
will not accrue interest.

 

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 Inc. and
diluted earnings per share.

Our "Non-GAAP net income attributable to Biogen Inc." and "Non-GAAP
earnings per share - Diluted" financial measures exclude the following
items from "GAAP net income attributable to Biogen Inc." and "GAAP
earnings per share - Diluted":

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 or deconsolidation of variable interest
entities for which we are the primary beneficiary. These adjustments
include, but are not limited to, charges for in-process research and
development, the amortization of certain acquired intangible assets, and
charges or credits from the fair value remeasurement of our contingent
consideration obligations.

2. Hemophilia business separation costs
We
have excluded costs that are directly associated with the set up and
spin-off of our hemophilia business into an independent, publicly-traded
company on February 1, 2017. These costs represent incremental third
party costs attributable solely to hemophilia separation and set up
activities.

3. Restructuring, business transformation and
other cost saving initiatives

We exclude costs associated
with the company's execution of certain strategies and initiatives to
streamline operations, achieve targeted cost reductions, rationalize
manufacturing facilities or refocus R&D activities. These costs may
include employee separation costs, retention bonuses, facility closing
and exit costs, asset impairment charges or additional depreciation when
the expected useful life of certain assets have been shortened due to
changes in anticipated usage, and other costs or credits that management
believes do not have a direct correlation to our on-going or future
business operations.

4. Loss (gain) on equity security investments
Effective
January 2018, we exclude unrealized and realized gains and losses and
discounts or premiums on our equity security investments as we do not
believe that these components of income or expense have a direct
correlation to our on-going or future business operations.

5. Other items
We evaluate other items
of income and expense 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
Inc. and diluted earnings per share.

 

TABLE 4
BIOGEN INC. AND SUBSIDIARIES
PRODUCT
REVENUES

(unaudited, in millions)

         
For the Three Months Ended
March 31, 2018     March 31, 2017     December 31, 2017
            United

States

    Rest of

World

    Total United

States

    Rest of

World

    Total     United

States

    Rest of

World

    Total
Multiple Sclerosis (MS):    
TECFIDERA $ 728.9 $ 258.0 $ 986.9 $ 751.1 $ 207.1 $ 958.2 $ 831.6 $ 244.0 $ 1,075.6
Interferon* 371.4 178.9 550.3 464.8 183.5 648.3 449.3 195.6 644.9
TYSABRI 249.7 212.4 462.1 305.5 239.5 545.0 252.1 210.6 462.7
FAMPYRA 24.4 24.4 20.5 20.5 24.2 24.2
ZINBRYTA 1.4 1.4 10.7 10.7 11.7 11.7
Spinal Muscular Atrophy:
SPINRAZA 188.0 175.9 363.9 46.4 1.0 47.4 218.2 144.3 362.5
Hemophilia:
ELOCTATE 42.2 6.2 48.4
ALPROLIX 21.0 5.0 26.0
Other Product Revenues:
FUMADERM 7.0 7.0 9.7 9.7 8.9 8.9
BENEPALI 120.9 120.9 65.3 65.3 117.6 117.6
FLIXABI   6.6   6.6     0.6   0.6         4.3   4.3
Total product revenues $ 1,538.0   $ 985.5   $ 2,523.5   $ 1,631.0   $ 749.1   $ 2,380.1       $ 1,751.2   $ 961.2   $ 2,712.4
 

*Interferon includes AVONEX and PLEGRIDY

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