[July 24, 2015] |
|
Biogen Second Quarter 2015 Revenues Increase 7% to $2.6 Billion
Biogen Inc. (NASDAQ: BIIB) today reported second quarter 2015 results,
including revenues of $2.6 billion, a 7% increase compared to the second
quarter of 2014. Non-GAAP diluted earnings per share (EPS) for the
second quarter of 2015 were $4.22, an increase of 21% over the second
quarter of 2014. Non-GAAP net income attributable to Biogen for the
second quarter of 2015 was $995 million, an increase of 20% over the
second quarter of 2014.
On a reported basis, GAAP diluted EPS for the second quarter of 2015
were $3.93, an increase of 31% over the second quarter of 2014. GAAP net
income attributable to Biogen for the second quarter of 2015 was $927
million, an increase of 30% versus the same period in the prior year. (A
reconciliation of GAAP to Non-GAAP quarterly financial results can be
found in Table 3 at the end of this release).
"Biogen remains focused on improving the lives of people living with
complex diseases," said Chief Executive Officer George A. Scangos, Ph.D.
"TECFIDERA, which is now the most prescribed oral MS therapy globally,
is experiencing moderated patient growth following rapid initial uptake.
The launch of PLEGRIDY® is expanding into new markets, and
TYSABRI® continues to add new patients requiring higher
efficacy. Additionally, our hemophilia products are being adopted by an
increasing number of patients, and we are working toward the anticipated
launches of our first two biosimilar candidates in Europe next year."
"The Company also continues to invest in the science that is core to our
future," Dr. Scangos continued, "and we are continuing to advance our
pipeline in areas where patients have limited or no treatment options.
We are excited to report we are now actively recruiting for two global
Phase 3 studies of aducanumab in patients with early Alzheimer's
disease. We see aducanumab as a potentially transformational opportunity
for Biogen, and for patients with this devastating disease."
Second Quarter 2015 Financial Highlights
-
Total multiple sclerosis product sales were $2.1 billion compared to
$2.0 billion in the same quarter last year.
-
TECFIDERA revenues were $883 million compared to $700 million in the
same quarter last year. These results consisted of $721 million in
U.S. sales and $163 million in sales outside the U.S. compared to $585
million and $115 million, respectively, in the second quarter of 2014.
-
TECFIDERA revenues in the second quarter of 2015 increased 7% from
$825 million in the first quarter of 2015. In the U.S., TECFIDERA
revenues increased 11%, which was partially offset by an 8%
decrease outside the U.S. The decrease outside the U.S. was
primarily due to lower pricing in Germany, as unit volume
increased 14%.
-
Interferon revenues, including AVONEX® and PLEGRIDY, were
$690 million compared to $774 million in the same quarter last year.
These results consisted of $455 million in U.S. sales and $235 million
in sales outside the U.S. compared to $498 million and $276 million,
respectively, in the second quarter of 2014.
-
Interferon revenues in the second quarter of 2015 decreased 9%
from $755 million in the first quarter of 2015. Interferon
revenues decreased 12% in the U.S. and 1% outside the U.S. versus
the first quarter of 2015. The Company believes the majority of
the U.S. decrease is due to an inventory reduction in the
wholesale channel.
-
TYSABRI revenues were $463 million compared to $533 million in the
same quarter last year. These results consisted of $269 million in
U.S. sales and $195 million in sales outside the U.S. compared to $250
million and $284 million, respectively, in the second quarter of 2014.
TYSABRI revenues outside the U.S. decreased 31% versus the second
quarter of 2014, due primarily to the recognition of $54 million of
previously deferred revenues in Italy in the second quarter of 2014
following a pricing agreement with AIFA.
-
Net revenues relating to RITUXAN® and GAZYVA®
from our unconsolidated joint business arrangement were $338 million
compared to $303 million in the same quarter last year.
-
ELOCTATE® revenues were $74 million and ALPROLIX®
revenues were $54 million.
-
Revenues for FAMPYRA® and FUMADERM™ were $34 million
compared to $38 million in the same quarter last year.
-
Royalty revenues were $9 million compared to $40 million in the same
quarter last year. The decrease is primarily due to the cessation of
ANGIOMAX® royalty payments following the expiration of
applicable U.S. patent rights in December 2014.
-
Corporate partner revenues were $47 million compared to $22 million in
the same quarter last year.
-
Foreign exchange, offset by hedging, weakened total revenues by
approximately $79 million compared to the second quarter of 2014.
-
Non-GAAP SG&A expense was $492 million compared to $540 million in the
same quarter last year. GAAP SG&A expense was $492 million compared to
$577 million in the same quarter last year.
-
Non-GAAP R&D expense was $491 million compared to $446 million in the
same quarter last year. GAAP R&D expense was $491 million compared to
$447 million in the same quarter last year.
-
As of June 30, 2015, Biogen had cash, cash equivalents and marketable
securities totaling approximately $4.5 billion.
-
In May 2015, Biogen announced that its Board of Directors authorized a
program to repurchase up to $5 billion of the Company's common stock.
Biogen currently expects that purchases will be executed within a
period of up to five years.
2015 Financial Guidance
As previously announced, the Company plans to provide annual financial
guidance and one update per year. Biogen's mid-year update to its full
year 2015 financial guidance consists of the following components:
-
Revenue growth is expected to be approximately 6% to 8% compared to
2014, a decrease from prior guidance based largely on revised
expectations for the growth of TECFIDERA.
-
R&D expense is expected to be approximately 19% to 20% of total
revenue, unchanged from prior guidance.
-
SG&A expense is expected to be approximately 20% to 21% of total
revenue, unchanged from prior guidance.
-
GAAP diluted EPS is expected to be between $14.25 and $14.70, a
decrease from prior guidance.
-
Non-GAAP diluted EPS is expected to be between $15.50 and $15.95, a
decrease from prior guidance.
Biogen may incur charges, realize gains or experience other events in
2015 that could cause actual results to vary from this guidance.
Neurology Highlights
-
In April 2015, the U.S. Food and Drug Administration accepted for
review the Biologics License Application for ZINBRYTA™ for the
treatment of relapsing forms of multiple sclerosis. ZINBRYTA is being
jointly developed by Biogen and AbbVie.
-
In June 2015, Biogen's collaboration partner Isis Pharmaceuticals
announced additional data from two Phase 2 studies of ISIS-SMNRx
for the treatment of spinal muscular atrophy in infants and children.
Available data to date continues to support further development, and
two Phase 3 studies are active and currently enrolling patients.
-
In July 2015, Biogen and Applied Genetic Technologies Corporation
(AGTC) announced a broad collaboration and license agreement to
develop gene therapies for multiple ophthalmic diseases. The
collaboration will focus on the development of a portfolio of AGTC's
therapeutic programs, including both a clinical stage candidate and a
pre-clinical candidate for orphan diseases of the retina that can lead
to blindness in children and adults.
-
In July 2015, Biogen presented new data from the Phase 1b PRIME study
of aducanumab at the Alzheimer's Association International Conference®.
Consistent with previously reported results, the one-year data from
the 6 mg/kg arm demonstrated a statistically significant reduction of
beta amyloid in the brain. In exploratory analyses, the 6 mg/kg dose
showed an improvement in the slowing of clinical decline, as measured
by the Mini Mental State Examination (MMSE) and Clinical Dementia
Rating sum of boxes (CDR-SB) scales, which was not statistically
significant. In a pre-specified analysis across placebo and all doses
of aducanumab, the slowing of clinical decline was shown to be
dose-dependent, and this dose-dependence achieved statistical
significance for both scales. In this analysis, aducanumab
demonstrated acceptable safety and tolerability.
-
Biogen recently initiated clinical sites for two global Phase 3
studies, EMERGE and ENGAGE, for aducanumab in Alzheimer's disease.
EMERGE and ENGAGE are each planned to enroll 1,350 patients with early
Alzheimer's disease.
-
Plans are underway to continue the development of TYSABRI
(natalizumab) for acute ischemic stroke following the Company's Phase
2 study. While the Phase 2 results did not demonstrate an impact on
change in infarct volume, the primary endpoint, secondary and
exploratory clinical endpoints suggest that TYSABRI did have a
beneficial impact on patient functional deficits.
-
Biogen has ceased development of Neublastin in moderate to severe
sciatica after Phase 2 study results failed to meet the Company's
targeted product profile.
Hemophilia Highlights
-
In June 2015, Biogen presented 23 Company-sponsored platform and
poster presentations at the International Society on Thrombosis and
Haemostasis 2015 Congress. The data presented included full results
from the Kids B-LONG study of ALPROLIX in children with hemophilia B
as well as interim results on the long-term safety and efficacy of
ELOCTATE in hemophilia A from the ASPIRE extension study.
-
In June 2015, Biogen and Swedish Orphan Biovitrum AB (Sobi) announced
that the European Medicines Agency accepted the Marketing
Authorization Application of ALPROLIX for the treatment of hemophilia
B. In July 2015, Sobi exercised its opt-in right to assume final
development and commercialization responsibilities for ALPROLIX for
the territory composed of Europe, North Africa, Russia and certain
Middle Eastern markets.
Other Events
-
In June 2015, Biogen and Samsung Bioepis Co., Ltd presented results
from their anti-TNF biosimilar portfolio at the European League
Against Rheumatism Annual Congress (EULAR 2015).
-
In June 2015, Biogen announced that it has achieved carbon neutrality,
a milestone reached through a multi-year initiative to reduce its own
emissions and by investing in environmental projects to offset the
remaining carbon associated with its business.
-
In June 2015, Biogen announced that it intends to build a new, next
generation manufacturing facility in Solothurn, Switzerland to support
its emerging pipeline. Biogen also recently entered into a definitive
agreement with Eisai Co., Ltd. to transfer ownership of Eisai's
Research Triangle Park manufacturing campus to Biogen.
-
In July 2015, Biogen announced that Douglas Williams, Ph.D., Executive
Vice President of Research & Development, will leave the Company at
the end of July to become chief executive officer of a start-up
biotechnology company.
Conference Call and Webcast
The Company's earnings conference call for the second quarter will be
broadcast via the internet at 8:30 a.m. EDT on July 24, 2015, 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 Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers to patients worldwide innovative therapies for the
treatment of neurodegenerative diseases, hematologic conditions and
autoimmune disorders. Founded in 1978, Biogen is one of the world's
oldest independent biotechnology companies and patients worldwide
benefit from its leading multiple sclerosis and innovative hemophilia
therapies. For product labeling, press releases and additional
information about the Company, please visit www.biogen.com.
Safe Harbor
This press release contains forward-looking statements, including
statements relating to: product growth prospects; pipeline potential and
progress; planned enrollment of clinical trials; anticipated benefits
and potential of investments, collaborations and business development
activities; timing and execution of stock repurchases; and 2015 guidance
and other financial matters. 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 principal products; failure
to compete effectively due to significant product competition in the
markets for our products; failure to protect and enforce our data,
intellectual property and other proprietary rights and the risks and
uncertainties relating to intellectual property claims; difficulties in
obtaining adequate coverage or changes in pricing or the availability of
reimbursement for our products; the occurrence of adverse safety events,
restrictions on use with our products or product liability claims;
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;
our dependence on collaborators and other third parties for the
development and commercialization of products and other aspects of our
business, which are outside of our control; failure to manage our growth
and execute our growth initiatives; problems with our manufacturing
processes; risks relating to investment in and expansion of
manufacturing capacity for future clinical and commercial requirements;
failure to comply with legal and regulatory requirements; the risks of
doing business internationally, including currency exchange rate
fluctuations; charges and other costs relating to our properties;
fluctuations in our effective tax rate; the market, interest and credit
risks associated with our portfolio of marketable securities; risks
relating to our ability to repurchase stock, including at favorable
prices; 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 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,
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product, net
|
|
|
|
$
|
2,198,566
|
|
|
|
|
$
|
2,056,292
|
|
|
|
$
|
4,370,888
|
|
|
|
|
$
|
3,799,057
|
|
Unconsolidated joint business
|
|
|
|
|
337,510
|
|
|
|
|
|
303,296
|
|
|
|
|
668,121
|
|
|
|
|
|
600,181
|
|
Royalty
|
|
|
|
|
8,583
|
|
|
|
|
|
40,344
|
|
|
|
|
28,397
|
|
|
|
|
|
78,200
|
|
Corporate partner
|
|
|
|
|
46,983
|
|
|
|
|
|
21,520
|
|
|
|
|
79,199
|
|
|
|
|
|
73,765
|
|
Total revenues
|
|
|
|
|
2,591,642
|
|
|
|
|
|
2,421,452
|
|
|
|
|
5,146,605
|
|
|
|
|
|
4,551,203
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, excluding amortization of acquired intangible assets
|
|
|
|
|
286,120
|
|
|
|
|
|
291,887
|
|
|
|
|
598,551
|
|
|
|
|
|
571,132
|
|
Research and development
|
|
|
|
|
490,728
|
|
|
|
|
|
447,273
|
|
|
|
|
951,277
|
|
|
|
|
|
976,157
|
|
Selling, general and administrative
|
|
|
|
|
491,895
|
|
|
|
|
|
576,622
|
|
|
|
|
1,052,256
|
|
|
|
|
|
1,088,296
|
|
Amortization of acquired intangible assets
|
|
|
|
|
92,004
|
|
|
|
|
|
116,826
|
|
|
|
|
187,907
|
|
|
|
|
|
260,084
|
|
(Gain) loss on fair value remeasurement of contingent consideration
|
|
|
|
|
(2,201
|
)
|
|
|
|
|
4,019
|
|
|
|
|
5,643
|
|
|
|
|
|
3,220
|
|
Total cost and expenses
|
|
|
|
|
1,358,546
|
|
|
|
|
|
1,436,627
|
|
|
|
|
2,795,634
|
|
|
|
|
|
2,898,889
|
|
Gain on sale of rights
|
|
|
|
|
-
|
|
|
|
|
|
3,900
|
|
|
|
|
-
|
|
|
|
|
|
7,759
|
|
Income from operations
|
|
|
|
|
1,233,096
|
|
|
|
|
|
988,725
|
|
|
|
|
2,350,971
|
|
|
|
|
|
1,660,073
|
|
Other income (expense), net
|
|
|
|
|
(10,889
|
)
|
|
|
|
|
4,861
|
|
|
|
|
(25,875
|
)
|
|
|
|
|
(740
|
)
|
Income before income tax expense and equity in loss of investee, net
of tax
|
|
|
|
|
1,222,207
|
|
|
|
|
|
993,586
|
|
|
|
|
2,325,096
|
|
|
|
|
|
1,659,333
|
|
Income tax expense
|
|
|
|
|
292,501
|
|
|
|
|
|
268,521
|
|
|
|
|
574,382
|
|
|
|
|
|
446,935
|
|
Equity in loss of investee, net of tax
|
|
|
|
|
4,881
|
|
|
|
|
|
1,933
|
|
|
|
|
5,715
|
|
|
|
|
|
9,538
|
|
Net income
|
|
|
|
|
924,825
|
|
|
|
|
|
723,132
|
|
|
|
|
1,744,999
|
|
|
|
|
|
1,202,860
|
|
Net income (loss) attributable to noncontrolling interests, net of
tax
|
|
|
|
|
(2,451
|
)
|
|
|
|
|
8,626
|
|
|
|
|
(4,818
|
)
|
|
|
|
|
8,398
|
|
Net income attributable to Biogen Inc.
|
|
|
|
$
|
927,276
|
|
|
|
|
$
|
714,506
|
|
|
|
$
|
1,749,817
|
|
|
|
|
$
|
1,194,462
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share attributable to Biogen Inc.
|
|
|
|
$
|
3.94
|
|
|
|
|
$
|
3.02
|
|
|
|
$
|
7.44
|
|
|
|
|
$
|
5.05
|
|
Diluted earnings per share attributable to Biogen Inc.
|
|
|
|
$
|
3.93
|
|
|
|
|
$
|
3.01
|
|
|
|
$
|
7.42
|
|
|
|
|
$
|
5.03
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in calculating:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share attributable to Biogen Inc.
|
|
|
|
|
235,286
|
|
|
|
|
|
236,661
|
|
|
|
|
235,122
|
|
|
|
|
|
236,729
|
|
Diluted earnings per share attributable to Biogen Inc.
|
|
|
|
|
235,718
|
|
|
|
|
|
237,401
|
|
|
|
|
235,671
|
|
|
|
|
|
237,634
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TABLE 2
|
|
BIOGEN INC. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
As of
|
|
|
|
|
June 30, 2015
|
|
|
|
December 31, 2014
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
|
|
$
|
2,368,673
|
|
|
|
$
|
1,845,384
|
Accounts receivable, net
|
|
|
|
|
1,310,821
|
|
|
|
|
1,292,445
|
Inventory
|
|
|
|
|
865,738
|
|
|
|
|
804,022
|
Other current assets
|
|
|
|
|
1,073,753
|
|
|
|
|
730,822
|
Total current assets
|
|
|
|
|
5,618,985
|
|
|
|
|
4,672,673
|
Marketable securities
|
|
|
|
|
2,101,796
|
|
|
|
|
1,470,652
|
Property, plant and equipment, net
|
|
|
|
|
1,837,670
|
|
|
|
|
1,765,683
|
Intangible assets, net
|
|
|
|
|
4,294,791
|
|
|
|
|
4,028,507
|
Goodwill
|
|
|
|
|
2,154,341
|
|
|
|
|
1,760,249
|
Investments and other assets
|
|
|
|
|
751,588
|
|
|
|
|
618,795
|
TOTAL ASSETS
|
|
|
|
$
|
16,759,171
|
|
|
|
$
|
14,316,559
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of notes payable
|
|
|
|
$
|
3,262
|
|
|
|
$
|
3,136
|
Other current liabilities
|
|
|
|
|
2,552,570
|
|
|
|
|
2,216,570
|
Notes payable
|
|
|
|
|
576,207
|
|
|
|
|
582,061
|
Long-term deferred tax liability
|
|
|
|
|
138,403
|
|
|
|
|
50,656
|
Other long-term liabilities
|
|
|
|
|
915,731
|
|
|
|
|
650,096
|
Equity
|
|
|
|
|
12,572,998
|
|
|
|
|
10,814,040
|
TOTAL LIABILITIES AND EQUITY
|
|
|
|
$
|
16,759,171
|
|
|
|
$
|
14,316,559
|
|
|
|
|
|
|
|
|
|
|
|
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 basis and on a non-GAAP basis is as follows:
|
|
|
|
|
|
|
For the Three Months
|
|
|
|
For the Six Months
|
|
|
|
|
Ended June 30,
|
|
|
|
Ended June 30,
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP earnings per share - Diluted
|
|
|
|
$
|
3.93
|
|
|
|
|
$
|
3.01
|
|
|
|
|
$
|
7.42
|
|
|
|
|
$
|
5.03
|
|
Adjustments to GAAP net income attributable to Biogen Inc. (as
detailed below)
|
|
|
|
|
0.29
|
|
|
|
|
|
0.48
|
|
|
|
|
|
0.62
|
|
|
|
|
|
0.93
|
|
Non-GAAP earnings per share - Diluted
|
|
|
|
$
|
4.22
|
|
|
|
|
$
|
3.49
|
|
|
|
|
$
|
8.04
|
|
|
|
|
$
|
5.96
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
An itemized reconciliation between net income attributable to Biogen
Inc. on a GAAP basis and on a non-GAAP basis is as follows:
|
|
|
|
|
|
|
For the Three Months
|
|
|
|
For the Six Months
|
|
|
|
|
Ended June 30,
|
|
|
|
Ended June 30,
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income attributable to Biogen Inc.
|
|
|
|
$
|
927.3
|
|
|
|
|
$
|
714.5
|
|
|
|
|
$
|
1,749.8
|
|
|
|
|
$
|
1,194.5
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
|
|
|
86.8
|
|
|
|
|
|
113.0
|
|
|
|
|
|
179.3
|
|
|
|
|
|
252.8
|
|
(Gain) loss on fair value remeasurement of contingent consideration
|
|
|
|
|
(2.2
|
)
|
|
|
|
|
4.0
|
|
|
|
|
|
5.6
|
|
|
|
|
|
3.2
|
|
SG&A: Stock option expense
|
|
|
|
|
-
|
|
|
|
|
|
1.5
|
|
|
|
|
|
-
|
|
|
|
|
|
4.0
|
|
R&D: Stock option expense
|
|
|
|
|
-
|
|
|
|
|
|
1.2
|
|
|
|
|
|
-
|
|
|
|
|
|
3.5
|
|
Donation to Biogen Foundation
|
|
|
|
|
-
|
|
|
|
|
|
35.0
|
|
|
|
|
|
-
|
|
|
|
|
|
35.0
|
|
Income tax effect related to reconciling items
|
|
|
|
|
(17.1
|
)
|
|
|
|
|
(40.1
|
)
|
|
|
|
|
(39.7
|
)
|
|
|
|
|
(77.1
|
)
|
Non-GAAP net income attributable to Biogen Inc.
|
|
|
|
$
|
994.8
|
|
|
|
|
$
|
829.1
|
|
|
|
|
$
|
1,895.0
|
|
|
|
|
$
|
1,415.9
|
|
|
|
2015 Full Year Guidance: GAAP to Non-GAAP Reconciliation
|
|
|
|
An itemized reconciliation between projected net income attributable
to Biogen Inc. and diluted earnings per share on a GAAP basis and on
a non-GAAP basis is as follows:
|
|
|
|
|
|
|
|
$
|
|
|
|
|
Shares
|
|
|
|
Diluted EPS
|
|
Projected GAAP net income attributable to Biogen Inc.
|
|
|
|
$
|
3,411.6
|
|
|
|
|
|
235.7
|
|
|
|
|
$
|
14.48
|
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
|
|
|
|
358.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss on fair value remeasurement of contingent consideration
|
|
|
|
|
15.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax effect related to reconciling items
|
|
|
|
|
(80.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected Non-GAAP net income attributable to Biogen Inc.
|
|
|
|
$
|
3,705.7
|
|
|
|
|
|
235.7
|
|
|
|
|
$
|
15.73
|
|
|
|
|
|
|
|
Numbers may not foot due to rounding.
|
|
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 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 remeasurement of our contingent consideration obligations.
2. Stock option expense recorded in accordance
with the accounting standard for share-based payments.
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
Inc.
|
TABLE 4
|
|
BIOGEN INC. AND SUBSIDIARIES
|
PRODUCT REVENUES
|
(unaudited, in millions)
|
|
|
|
|
|
|
|
|
|
For the Three Months
|
|
|
For the Six Months
|
|
|
|
|
Ended June 30,
|
|
|
Ended June 30,
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
PRODUCT REVENUES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Multiple Sclerosis (MS):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TECFIDERA
|
|
|
|
$
|
883.3
|
|
|
$
|
700.4
|
|
|
$
|
1,708.2
|
|
|
$
|
1,206.1
|
AVONEX
|
|
|
|
|
615.2
|
|
|
|
773.8
|
|
|
|
1,307.9
|
|
|
|
1,535.3
|
PLEGRIDY
|
|
|
|
|
74.5
|
|
|
|
-
|
|
|
|
136.3
|
|
|
|
-
|
TYSABRI
|
|
|
|
|
463.1
|
|
|
|
533.4
|
|
|
|
925.7
|
|
|
|
974.4
|
FAMPYRA
|
|
|
|
|
21.1
|
|
|
|
22.3
|
|
|
|
41.1
|
|
|
|
41.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hemophilia:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALPROLIX
|
|
|
|
|
54.4
|
|
|
|
10.4
|
|
|
|
97.5
|
|
|
|
10.4
|
ELOCTATE
|
|
|
|
|
74.3
|
|
|
|
-
|
|
|
|
127.9
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other product revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FUMADERM
|
|
|
|
|
12.7
|
|
|
|
16.0
|
|
|
|
26.3
|
|
|
|
31.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues, net
|
|
|
|
$
|
2,198.6
|
|
|
$
|
2,056.3
|
|
|
$
|
4,370.9
|
|
|
$
|
3,799.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20150724005075/en/
[ Back To TMCnet.com's Homepage ]
|