Total revenues grew 3%, or 8% excluding
hemophilia revenues*
SPINRAZA launch in the U.S. off to a strong
start; Company receives positive CHMP opinion for SPINRAZA and
prepares for launch in Europe
TECFIDERA U.S. patents upheld in both IPR and
interference proceedings
Biogen Inc. (NASDAQ: BIIB) today reported first quarter 2017
financial results, including:
- Total revenues of $2.8 billion, a 3%
increase versus the prior year and an 8% increase excluding
hemophilia revenues*.
- TYSABRI® revenue grew 14% versus the
prior year. Outside the U.S., TYSABRI revenues benefited 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.
- Versus Q4 2016, Biogen estimates
TECFIDERA® U.S. revenues were negatively impacted by approximately
$50 million to $60 million due to lower inventory levels in the
channel.
- Worldwide SPINRAZA® revenues were $47
million.
- GAAP net income and diluted earnings
per share (EPS) attributable to Biogen Inc. of $748 million and
$3.46, respectively.
- GAAP net income and diluted EPS were
negatively impacted by $263 million and $1.22, net of tax,
respectively, related to the settlement and license agreement with
Forward Pharma including consideration of the U.S. Patent and
Trademark Office (USPTO) ruling in favor of Biogen in the
interference proceeding.
- Non-GAAP net income and diluted EPS
attributable to Biogen Inc. of $1.1 billion and $5.20,
respectively.
* Total Q1 2017 revenues include hemophilia revenues only for
the month of January. The 8% increase in total revenues excludes
all hemophilia revenues from Q1 2016 and 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 '17 Q4 '16 Q1 '16
Q1 '17 v. Q4 '16
Q1 '17 v. Q1 '16
Total revenues** $ 2,811 $ 2,872 $ 2,727 (2%)** 3%** GAAP
net income*** $ 748 $ 649 $ 971 15 % (23 %) GAAP diluted EPS $ 3.46
$ 2.99 $ 4.43 16 % (22 %) Non-GAAP net income*** $ 1,123 $
1,093 $ 1,049 3 % 7 % Non-GAAP diluted EPS $ 5.20 $ 5.04 $ 4.79 3 %
9 %
** Total revenues grew 4% versus Q4 2016 and 8% versus Q1 2016
excluding hemophilia.***Net income attributable to Biogen Inc.
A reconciliation of GAAP to Non-GAAP quarterly financial results
can be found in Table 3 at the end of this press release.
“I am very pleased with the results of the first quarter. We saw
continued stability in our MS business, executed a strong launch of
SPINRAZA, grew market share for our biosimilars business across
Europe, and reinforced the intellectual property for TECFIDERA,”
said Chief Executive Officer Michel Vounatsos. “Furthermore, we
continued to build our neurology pipeline with the anticipated
addition of our new Phase 2-ready anti-tau antibody.”
“We are encouraged by the progress we made launching SPINRAZA in
the U.S., and, following the positive CHMP opinion, we are ramping
up pre-launch activities in Europe. The value this therapy provides
to patients is compelling, and we are working to accelerate patient
access globally,” Vounatsos continued. “Overall, I believe we’re
building positive momentum at the company, and I look forward to
leading Biogen into a new and exciting era.”
Revenue
Highlights
(In millions) Q1 '17 Q4
'16 Q1 '16
Q1 '17 v. Q4 '16
Q1 '17 v. Q1 '16
Multiple Sclerosis: TECFIDERA $ 958 $ 1,002 $ 946 (4 %) 1 % Total
Interferon $ 648 $ 688 $ 670 (6 %) (3 %) AVONEX® $ 537 $ 564 $ 564
(5 %) (5 %) PLEGRIDY® $ 112 $ 125 $ 106 (10 %) 5 % TYSABRI $ 545 $
474 $ 477 15 % 14 % FAMPYRATM $ 20 $ 22 $ 20 (7 %) 1 % ZINBRYTA® $
11 $ 6 $ — 81 % NMF Hemophilia: ELOCTATE**** $ 48 $ 149 $
108 (68 %) (55 %) ALPROLIX**** $ 26 $ 93 $ 75 (72 %) (65 %)
Spinal Muscular Atrophy SPINRAZA $ 47 $ 5 $ — NMF NMF Other
Product Revenues: Biosimilars $ 66 $ 53 $ 2 25 % NMF FUMADERMTM $
10 $ 11 $ 11 (15 %) (15 %)
Total Product Revenues: $ 2,380
$ 2,503 $ 2,309 (5 %)
3 % Anti-CD20 Revenues $ 341 $ 318 $ 329 7 % 3
% Other Revenues**** $ 90 $ 51 $ 88 77 % 2 %
Total Revenues**
$ 2,811 $ 2,872
$ 2,727
(2%)** 3%**
Note: Numbers may not foot due to rounding; percent changes
represented as favorable & (unfavorable)**** Q1 2017 ELOCTATE
and ALPROLIX revenues reflect only the month of January, prior to
the spin-off of our hemophilia business. Other revenues include
royalty and contract manufacturing revenue related to Sobi only for
the month of January.
Expense
Highlights
(In millions) Q1 '17 Q4
'16 Q1 '16
Q1 '17 v. Q4 '16
Q1 '17 v. Q1 '16
GAAP cost of sales $ 385 $ 378 $ 313 (2 %) (23 %) Non-GAAP cost of
sales $ 385 $ 363 $ 313 (6 %) (23 %) GAAP R&D $ 423 $
534 $ 437 21 % 3 % Non-GAAP R&D $ 421 $ 531 $ 437 21 % 4 %
GAAP SG&A $ 499 $ 496 $ 497 (1 %) (0 %) Non-GAAP
SG&A $ 483 $ 484 $ 497 0 % 3 %
Note: Percent changes represented as favorable &
(unfavorable)
- Biogen also recorded GAAP-only pre-tax
charges in Q1 2017 of $354 million related to the settlement and
license agreement with Forward Pharma including consideration of
the USPTO ruling in favor of Biogen in the interference proceeding.
These charges are included in amortization of acquired intangible
assets and exceed the amounts anticipated in Biogen’s previously
announced 2017 full year GAAP financial guidance related to this
agreement.
Other Financial
Highlights
- As of March 31, 2017, Biogen had cash,
cash equivalents and marketable securities totaling approximately
$5.7 billion, and approximately $6.5 billion in notes payable and
other financing arrangements.
- For the first quarter of 2017, the
Company’s weighted average diluted shares were approximately 216
million. The Company ended the quarter with approximately 214
million basic shares outstanding.
- During the first quarter of 2017,
Biogen repurchased approximately 2 million shares of the Company’s
common stock for a total value of $584 million. Since the end of
the quarter, the Company has repurchased an additional
approximately 2 million shares for a total value of $543
million.
Business Development
Highlights
- In April 2017, Biogen announced an
agreement with Bristol-Myers Squibb to exclusively license
BMS-986168, an experimental medicine with potential in Alzheimer’s
disease and progressive supranuclear palsy (PSP), a rare condition
that affects movement, speech, vision, and cognitive function.
Biogen plans to initiate Phase 2 studies for BMS-986168 in both of
these indications. Biogen anticipates making an upfront payment of
$300 million to Bristol-Myers Squibb in the second quarter of 2017
as well as a near-term $60 million milestone payment to the former
stockholders of iPierian, Inc. upon initiation of a Phase 2 trial
for BMS-986168. These amounts exceed the estimated $100 million in
business development expense assumed in Biogen’s previously
announced 2017 full year financial guidance. This agreement 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 2017.
Other Recent Events
- At the 69th annual meeting of the
American Academy of Neurology (AAN) being held in Boston from April
22 to April 28, 2017, Biogen is presenting data from its portfolio
of treatments and investigational therapies for people with serious
neurological and neurodegenerative diseases. Platform and poster
presentations include new real-world evidence supporting TECFIDERA
and TYSABRI, underscoring the importance of early and appropriate
treatment for multiple sclerosis (MS); new data demonstrating the
clinically meaningful efficacy and favorable benefit-risk profile
of SPINRAZA for spinal muscular atrophy; and previously presented
results from the Phase 1b studies of aducanumab, an investigational
treatment for early Alzheimer’s disease.
- In April 2017, Biogen announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency adopted a positive opinion recommending
the granting of a marketing authorization in the European Union
(EU) for SPINRAZA (nusinersen) to treat patients with spinal
muscular atrophy. The CHMP reviewed SPINRAZA under an accelerated
assessment procedure, which is a regulatory mechanism to facilitate
earlier access to patients for medicines that fulfill unmet medical
needs. SPINRAZA is the first treatment for spinal muscular atrophy
to be recommended by the CHMP for approval in the EU.
- In March 2017, the USPTO ruled against
the Coalition for Affordable Drugs V LLC, an entity associated with
a hedge fund, in the inter partes review of Biogen’s U.S. Patent
No. 8,399,514 (the ‘514 patent). The ‘514 patent includes claims
covering the treatment of MS with 480 mg of dimethyl fumarate as
provided for in Biogen’s TECFIDERA label.
- In March 2017, the USPTO ruled against
Forward Pharma in the interference proceeding between Forward
Pharma’s pending U.S. Patent Application No. 11/576,871 and the
‘514 patent.
- In March 2017, Biogen presented data
from its Alzheimer’s and Parkinson’s disease programs at the 13th
International Conference on Alzheimer’s and Parkinson’s Diseases
(AD/PD™) in Vienna, Austria. The Biogen presentations included data
from research of Alzheimer’s and Parkinson’s disease biomarkers;
the investigational treatment for Alzheimer’s disease, aducanumab;
and the investigational treatment for Parkinson’s disease,
BIIB054.
- In March 2017, Roche announced that the
U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory
Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk
of rituximab/hyaluronidase for subcutaneous (under the skin)
injection was favorable for the treatment of certain blood cancers.
This new co-formulation includes the same monoclonal antibody as
intravenous RITUXAN® (rituximab) and hyaluronidase, a molecule that
helps to deliver medicine under the skin. The FDA is expected to
make a decision on approval by June 26, 2017. Roche and Biogen
collaborate on RITUXAN in the U.S.
- In March 2017, Biogen appointed Anirvan
Ghosh, Ph.D. as Senior Vice President, Research and Early
Development (RED). Dr. Ghosh will lead Biogen’s RED organization in
the discovery and development of drug candidates from idea through
proof of concept.
- In February 2017, Biogen announced the
completion of the separation of its global hemophilia business. The
new company, known as Bioverativ, is an independent, publicly
traded global biotechnology company focused on hemophilia and other
rare blood disorders. Bioverativ trades under the symbol “BIVV” on
the NASDAQ Global Select Market.
- In January 2017, Siemens Healthineers
and Biogen announced plans to jointly develop magnetic resonance
imaging (MRI) applications with the intent of quantifying key
markers of MS disease activity and progression.
- In January 2017, Biogen initiated a
Phase 1 trial of an anti-tau monoclonal antibody, BIIB076, in
healthy volunteers and participants with Alzheimer’s disease.
BIIB076 was derived from Neurimmune’s reverse translational
medicine platform.
Conference Call and WebcastThe Company's earnings
conference call for the first quarter will be broadcast via the
internet at 8:30 a.m. ET on April 25, 2017, and will be accessible
through the Investors section of Biogen’s homepage, www.biogen.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 at least one
month.
About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers innovative therapies
worldwide for people living with serious neurological and
neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in
biotechnology and today the Company has the leading portfolio of
medicines to treat multiple sclerosis, has introduced the first and
only approved treatment for spinal muscular atrophy, and is at the
forefront of neurology research for conditions including
Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral
sclerosis. Biogen also manufactures and commercializes biosimilars
of advanced biologics. For more information, please visit
www.biogen.com. Follow us on social
media - Twitter, LinkedIn, Facebook,
YouTube.
Safe HarborThis press release contains forward-looking
statements, including statements relating to: Biogen’s strategy and
plans; potential of our commercial business and pipeline programs;
clinical trials and data readouts and presentations; regulatory
filings and the timing thereof; and anticipated benefits and
potential of investments, collaborations, and business development
activities. These forward-looking statements may be accompanied by
such words as “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
“possible,” “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
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; risks associated with
current and potential future healthcare reforms; 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; 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; 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 relating to management and key personnel
changes, including attracting and retaining key personnel; problems
with our manufacturing processes; 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 the spin-off
of our hemophilia business, including risks of operational
difficulties, exposure to claims and liabilities, and the ability
to achieve some or all of the anticipated benefits; risks relating
to technology failures or breaches; failure to comply with legal
and regulatory requirements; fluctuations in our effective tax
rate; risks related to indebtedness; the risks of doing business
internationally, including currency exchange rate fluctuations;
risks relating to investment in and expansion of manufacturing
capacity for future clinical and commercial requirements; 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; 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; 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 MonthsEnded
March 31, 2017 2016
Revenues: Product, net $ 2,380.1 $ 2,309.4 Revenues from anti-CD20
therapeutic programs 340.6 329.5 Other 90.0 87.9
Total revenues 2,810.7 2,726.8 Cost and expenses:
Cost of sales, excluding amortization of acquired intangible assets
384.6 313.0 Research and development 423.4 437.3 Selling, general
and administrative 499.1 497.3 Amortization of acquired intangible
assets 448.5 88.8 Collaboration profit (loss) sharing 20.8 — (Gain)
loss on fair value remeasurement of contingent consideration 10.0
2.3 Restructuring charges — 9.7 Total cost and
expenses 1,786.4 1,348.4 Income from operations
1,024.3 1,378.4 Other income (expense), net (37.6 ) (52.8 ) Income
before income tax expense and equity in loss of investee, net of
tax 986.7 1,325.6 Income tax expense 239.2 356.4 Equity in loss of
investee, net of tax — — Net income 747.5 969.2 Net
income (loss) attributable to noncontrolling interests, net of tax
(0.1 ) (1.7 ) Net income attributable to Biogen Inc. $ 747.6
$ 970.9 Net income per share: Basic earnings per
share attributable to Biogen Inc. $ 3.47 $ 4.44
Diluted earnings per share attributable to Biogen Inc. $ 3.46
$ 4.43 Weighted-average shares used in
calculating: Basic earnings per share attributable to Biogen Inc.
215.6 218.9 Diluted earnings per share attributable
to Biogen Inc. 215.9 219.3
TABLE 2
BIOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(Unaudited) (in millions)
As of March
31,2017 As of December 31,2016
ASSETS Cash, cash equivalents and marketable securities $
2,880.2 $ 4,895.1 Accounts receivable, net 1,501.5 1,441.6
Inventory 921.6 1,001.6 Other current assets 1,556.4 1,393.9
Total current assets 6,859.7 8,732.2 Marketable securities 2,825.2
2,829.4 Property, plant and equipment, net 2,610.9 2,501.8
Intangible assets, net 4,103.9 3,808.3 Goodwill 3,611.7 3,669.3
Investments and other assets 1,184.5 1,335.8 TOTAL ASSETS $
21,195.9 $ 22,876.8
LIABILITIES AND EQUITY
Current liabilities 2,992.5 3,419.9 Notes payable and
other financing arrangements 5,952.7 6,512.7 Other long-term
liabilities 783.3 815.6 Equity 11,467.4 12,128.6 TOTAL
LIABILITIES AND EQUITY $ 21,195.9 $ 22,876.8
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, 2017 December 31, 2016
March 31, 2016 GAAP earnings per share
- Diluted $ 3.46 $ 2.99 $ 4.43 Adjustments to GAAP net income
attributable to Biogen Inc. (as detailed below) 1.74 2.05
0.36 Non-GAAP earnings per share - Diluted $ 5.20 $
5.04 $ 4.79
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,
2017 December 31, 2016
March 31, 2016 GAAP net income attributable to
Biogen Inc. $ 747.6 $ 649.2 $ 970.9 Adjustments: TECFIDERA
litigation settlement and license chargesA — 454.8 — Amortization
of acquired intangible assetsB 448.5 101.6 85.7 (Gain) loss on fair
value remeasurement of contingent consideration 10.0 (4.0 ) 2.3
(Gain) loss on deconsolidation of variable interest entities — (4.4
) — Hemophilia business separation costs 19.2 12.6 — Restructuring,
business transformation and other cost saving initiatives: —
Restructuring chargesC — 11.8 9.7 Cambridge manufacturing facility
rationalization costsD — 17.8 — Income tax effect related to
reconciling items (102.4 ) (146.2 ) (19.2 ) Non-GAAP net income
attributable to Biogen Inc. $ 1,122.9 $ 1,093.2 $
1,049.4
A In January 2017 we entered into a settlement and license
agreement among Biogen Swiss Manufacturing GmbH, Biogen
International Holding Ltd., Forward Pharma and certain related
parties, which was effective as of February 1, 2017. Pursuant to
the agreement, we obtained U.S. and rest of world licenses to
Forward Pharma's intellectual property, including Forward Pharma's
intellectual property related to TECFIDERA. In exchange, we paid
Forward Pharma $1.25 billion in cash. During the fourth
quarter of 2016, we recognized a pre-tax charge of $454.8 million
and in the first quarter of 2017 we recognized an intangible asset
of $795.2 million related to this agreement.
The pre-tax charge recognized in the fourth quarter of 2016
represented the fair value of our licenses to Forward Pharma’s
intellectual property for the period April 2014, when we started
selling TECFIDERA, through December 31, 2016. The intangible asset
represented the fair value of the U.S. and rest of world licenses
to Forward Pharma’s intellectual property related to TECFIDERA
revenues for the period January 2017, the month in which we entered
into the agreement, through December 2020, the last month before
royalty payments could first commence pursuant to the
agreement.
B Amortization of acquired intangible assets for the three
months ended March 31, 2017 includes $353.6 million of impairment
and amortization charges related to the intangible asset associated
with our U.S. and rest of world licenses to Forward Pharma’s
intellectual property related to TECFIDERA, as discussed in Note A
above. As we prevailed in the U.S. proceeding in March 2017, we
evaluated the recoverability of the U.S. asset acquired from
Forward Pharma and recorded an impairment charge 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 over
certain TECFIDERA intellectual property rights. We also continued
to amortize the remaining net book value of the U.S. and rest of
world licenses in our consolidated statements of income utilizing
an economic consumption model.
C Restructuring charges for the three months ended December 31,
2016 and March 31, 2016 include charges of $4.4 million and $9.7
million, respectively, incurred in connection with cost savings
measures primarily intended to realign our organizational structure
in anticipation of the changes in roles and workforce resulting
from our decision to spin-off our hemophilia business, and to
achieve further targeted cost reductions. Restructuring charges for
the three months ended December 31, 2016, also include severance
charges of $7.4 million related to employee separation costs as a
result of our decision to vacate and cease manufacturing in
Cambridge, MA and vacate our warehouse in Somerville, MA.
D Cambridge manufacturing facility rationalization costs reflect
additional depreciation, the write-down of excess inventory and
other direct costs associated with our decision to vacate and cease
manufacturing in Cambridge, MA and vacate our warehouse in
Somerville, MA. Additional depreciation expense, which totaled
$14.0 million for the three months ended December 31, 2016, is
included in cost of sales, excluding amortization of acquired
intangible assets in our condensed consolidated statements of
income. Also reflected in this amount for the three months ended
December 31, 2016 are charges of $1.4 million for the write-down of
excess inventory, which are included in cost of sales, excluding
amortization of acquired intangible assets in our condensed
consolidated statements of income.
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
adjustmentsWe 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
costsWe have excluded costs that are directly associated
with the set up and spin-off of our hemophilia business into an
independent, publicly-traded company. These costs represent
incremental third party costs attributable solely to hemophilia
separation and set up activities.
3. Restructuring, business transformation
and other cost saving initiativesWe 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. Other itemsWe 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, including in the fourth quarter of 2016, TECFIDERA
litigation settlement and license charges. 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.
TABLE 4
BIOGEN INC. AND SUBSIDIARIES
PRODUCT REVENUES
(Unaudited) (in millions)
For the Three Months
Ended March 31, 2017 December
31, 2016 March 31, 2016 (In
millions) United
States
Rest of
World
Total United
States
Rest of
World
Total United
States
Rest of
World
Total Multiple Sclerosis (MS):
TECFIDERA $ 751.1 $ 207.1 $ 958.2 $ 799.7 $ 202.3 $ 1,002.0 $ 744.3
$ 201.6 $ 945.9 Interferon* 464.8 183.5 648.3 488.1 200.1 688.2
467.5 202.9 670.4 TYSABRI 305.5 239.5 545.0 288.7 185.2 473.9 288.2
188.8 477.0 FAMPYRA — 20.5 20.5 — 22.0 22.0 — 20.2 20.2 ZINBRYTA —
10.7 10.7 — 5.9 5.9 — — — Hemophilia: ELOCTATE 42.2 6.2 48.4 126.2
22.8 149.0 98.7 9.0 107.7 ALPROLIX 21.0 5.0 26.0 73.7 19.5 93.2
64.6 10.4 75.0 Spinal Muscular Atrophy: SPINRAZA 46.4 1.0 47.4 4.6
— 4.6 — — — Other Product Revenues: FUMADERM — 9.7 9.7 — 11.4 11.4
— 11.4 11.4 BENEPALI — 65.3 65.3 — 52.7 52.7 — 1.8 1.8 FLIXABI —
0.6 0.6 — — — — —
— Total product revenues $ 1,631.0 $ 749.1 $
2,380.1 $ 1,781.0 $ 721.9 $ 2,502.9 $
1,663.3 $ 646.1 $ 2,309.4
*Interferon includes AVONEX and PLEGRIDY
View source
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BiogenMedia Contact:Jason Glashow,
781-464-3260orInvestor Contact:Matt Calistri,
781-464-2442
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