1. No category

First Quarter 2015 Financial Results
and Business Update
April 24, 2015
1
Forward-Looking Statements
This presentation contains forward-looking statements, including statements about the prospects of our product portfolio, the potential
and progress of our pipeline and business development activities, and anticipated clinical trials and data readouts. These forwardlooking 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 success in developing, licensing or acquiring other product candidates or additional indications for existing
products, including the risk that unexpected concerns 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;
results 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 or capacity; failure to comply with legal and regulatory requirements; the risks of doing business
internationally, including exchange rate fluctuations; charges and other costs relating to our properties; currency fluctuations;
fluctuations in our effective tax rate; 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 presentation. We do not
undertake any obligation to publicly update any forward-looking statements.
Note regarding trademarks: ALPROLIX®, AVONEX®, ELOCTATM, ELOCTATE®, FUMADERMTM, PLEGRIDY®, RITUXAN®,
TECFIDERA® and TYSABRI®, as used in this presentation, are trademarks or registered trademarks of Biogen or its subsidiaries.
FAMPYRA® is a registered trademark of Acorda Therapeutics, Inc. GAZYVA® is a registered trademark of Genentech, Inc.
2
Q1 2015 Earnings Call Agenda
Introduction
Ben Strain
Investor Relations
Overview
George Scangos, Ph.D.
Chief Executive Officer
R&D Update
Doug Williams, Ph.D.
EVP, Research & Development
Commercial Update
Tony Kingsley
EVP, Global Commercial Operations
Financial Update
Paul Clancy
EVP, Chief Financial Officer
Closing Remarks
George Scangos, Ph.D.
Chief Executive Officer
3
Overview
George Scangos, Ph.D.
Chief Executive Officer
4
Q1 2015 Financial Performance
Revenues ($M)
+20%
Diluted EPS ($)
+25%
+55%
+73%
$3.49
$3.82
$2,555
$2,130
$2,172
$2.47
Q1-15
Q1-14
$2.02
$1,743
Q1-14
Q1-15
Total
Q1-14
Product
Q1-15
Non-GAAP
Q1-14
Q1-15
GAAP
*A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentation
5
Recent Highlights
Financial Performance
R&D Progress
• 20% growth in revenues and 55% growth in nonGAAP diluted EPS year-over-year
• Compelling Phase 1b interim data for aducanumab
(BIIB037) presented at AD/PD conference
• 3% decrease in revenues and 7% decline in nonGAAP diluted EPS versus prior quarter
• 73 presentations at AAN highlighting marketed MS
therapies, anti-LINGO-1, and aducanumab
• Plan to initiate two aducanumab Phase 3 studies in
2015
Product Performance
• MS franchise continued to gain share, though at
moderating pace
• Slowing patient uptake of TECFIDERA in the US
and Germany
• Solid PLEGRIDY launch continues in US and EU
• TYSABRI continued to add patients as physicians
choose this therapy for patients requiring high
efficacy
• ALPROLIX for hemophilia B and ELOCTATE for
hemophilia A continuing to gain share in the US
• Recently initiated Phase 3 trial of TECFIDERA in
secondary progressive MS (SPMS)
• Progressed biosimilar programs through Samsung
Bioepis JV; etanercept and infliximab filed in the EU
• Upcoming potential value drivers:
– Phase 3 for TYSABRI in SPMS
(H2 2015)
– Phase 2 for TYSABRI in acute ischemic stroke
(mid 2015)
– Phase 2 for Neublastin in neuropathic pain
(mid 2015)
A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentation
6
2015 American Academy of Neurology Annual Meeting
Highlights
Data underscore commitment to
advancing patient care in neurology
TECFIDERA (dimethyl fumarate)
ZINBRYTA (daclizumab high-yield process)*


Data demonstrate strong and sustained efficacy
across a broad range of MS patients as well as
Data demonstrate superior efficacy to IFN beta-1a and
acceptable safety and tolerability in the DECIDE study
favorable long-term safety profile
Anti-LINGO-1 (BIIB033)
TYSABRI (natalizumab)


Data reinforce TYSABRI’s high efficacy, including for
Data provide clinical evidence in humans demonstrating
that anti-LINGO is able to remyelinate damaged neurons
patients switching from fingolimod
Aducanumab (BIIB037)*
PLEGRIDY (peginterferon beta-1a)


Additional Phase 1b data demonstrate aducanumab
New data from the ATTAIN study demonstrate the
resulted in a consistent impact on amyloid PET in ApoE4
long-term safety and efficacy over three years in
carriers vs. non-carriers, as well as in prodromal vs. mild
people with RRMS
AD patient subgroups.
* Collaboration programs.
7
Biosimilar Joint Venture
Highlights

Etanercept and infliximab biosimilar candidates
have been accepted for review by the EMA

Biogen has commercialization rights for anti-TNF
biosimilar product candidates in Europe and in the
case of one anti-TNF biosimilar, Japan

Biogen contributing expertise in protein engineering
and biologics manufacturing, world-class
development and analytical capabilities
PHASE I
PHASE II
PHASE III
FILED
Etanercept biosimilar
Infliximab biosimilar
Adalimumab biosimilar
8
R&D Update
Doug Williams, Ph.D.
EVP, Research & Development
9
AD/PD 2015* Highlights
Pre-specified interim analysis of
PRIME, the Phase 1b study of
aducanumab (BIIB037)
demonstrated:

BIIB037 Reduced Amyloid at One Year**
Treatment with aducanumab produced a
dose- and time-dependent reduction of
amyloid plaque

Dose-dependent, statistically significant
effect of slowing clinical decline was
Baseline
Week 54
observed on the MMSE and CDR scales

Aducanumab demonstrated an acceptable
safety and tolerability profile, ARIA observed
•
•
*The 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders
**Representative study data.
10
Aducanumab Clinical Development Highlights
Phase 1b Updates
Phase 3 Plan Updates
•
Study remains ongoing
•
•
1 year clinical results for the 6mg/kg study
cohort planned for 2015 AAIC meeting
•
Final regulatory feedback expected in coming
months
•
Expect to initiate two Phase 3 registrational
studies in the 2H 2015
Titration dosing results coming later
•
Anticipate two 18 month clinical studies, each in
~ 1,350 subjects with early Alzheimer’s disease
11
TECFIDERA Phase 3 Study in Secondary Progressive MS
Goal: Evaluate whether Tecfidera slows the
Rationale: Based on both biological and clinical
accumulation of disability in patients with secondary
evidence
progressive MS
Preclinical data demonstrate that Tecfidera has
cytoprotective and anti-inflammatory properties that
Study: INSPIRE, a phase 3, multicenter, international,
randomized, double-blind, placebo-controlled study in
1,170 patients
may address the lymphocytic infiltrates and
neurodegeneration known to occur in SPMS patients
Clinical data from the Tecfidera phase 3 studies also
demonstrated reduced disability progression in
subjects with higher levels of disability even when
Primary Endpoint: Time to confirmed progression,
they had not experienced recent relapses
based on a composite endpoint including EDSS, a timed
25 foot walk test and the 9 hole peg test
12
Deep Pipeline
Late-stage
PHASE I
ZINBRYTA*
PHASE III
Secondary Progressive Multiple Sclerosis
GAZYVA*
Diffuse Large B-Cell Lymphoma
GAZYVA*
Indolent Non-Hodgkin’s Lymphoma (Refractory & Frontline)
TECFIDERA
Secondary Progressive Multiple Sclerosis
ISIS-SMNRx*
Spinal Muscular Atrophy
Anti-LINGO
Anti-TWEAK
Alzheimer's Disease
Optic Neuritis; Multiple Sclerosis
Lupus Nephritis
BAN2401*
Alzheimer's Disease
Neublastin
Neuropathic Pain
CNV1014802
STX-100
TYSABRI
E2609*
Dapirolizumab pegol (Anti-CD40L)*
BIIB061
ISIS-DMPKRx*
Anti-BDCA2
FILED
Multiple Sclerosis
TYSABRI
Aducanumab ( BIIB037)*†
Early-stage
PHASE II
Trigeminal Neuralgia
Idiopathic Pulmonary Fibrosis
Acute Ischemic Stroke
Alzheimer’s Disease
SLE§
Multiple Sclerosis
Myotonic Dystrophy
SLE§
* Collaboration programs
†Phase 3 planning underway
§Systematic Lupus Erthematosus
13
Commercial Update
Tony Kingsley
EVP, Global Commercial Operations
14
Global MS Franchise Performance
MS Franchise Sales ($M)
+19%
$2,195
$2,030
$2,054
$700
$787
$2,062
$1,727
$916
$825
$506
$441
$533
#
$501
$484
$463
$3
$41
$62
$761
$774
$742
$736
$693
$19
$22
$20
$19
$20
Q1-14
Q2-14
Q3-14
Q4-14
Q1-15
FAMPYRA
AVONEX*
PLEGRIDY
TYSABRI*
TECFIDERA*
Note: Numbers may not foot due to rounding.
* In the US, TECFIDERA and AVONEX had 14 shipping weeks in Q4’14 and 13 in all other quarters shown. In the US, TYSABRI had 13 shipping weeks in Q1’15
versus 12 in Q1’14, 13 in Q2’14, 14 in Q3’14, and 13 in Q4’14.
# Q2’14 TYSABRI sales outside the U.S. included $54 million of previously deferred revenue from February 2013 through March 31, 2014, which was recognized
during Q2’14 following an agreement with AIFA. Beginning in the second quarter of 2014, we recorded TYSABRI revenues in Italy at the full reimbursed price.
15
Global TECFIDERA Performance
TECFIDERA Revenue ($M)
Q1 2015 Highlights
• Revenue vs. Q4 2014 & Q1 2014
$916
$787
$700
$173
WW
US
ROW
$825
$177
$149
+ 63%
+ 41%
+ 285%
• Continued to add patients globally, but at slower rate
$115
• In US, 14 shipping weeks in Q4 2014 and 13 in all other
quarters shown. Extra week in Q4 ~$50 million
$506
$46
$585
$638
$743
ROW
$648
US
$460
Q1-14
- 10% and
- 13% and
+ 2% and
Q2-14
Q3-14
Q4-14
Q1-15
• Q1 2015 discounts and allowances ~400 basis points
higher than estimated run rate for remainder of the year
• Recent US performance impacted by:
– Decline in overall market growth rate and switch rate
– PML case in October 2014
– PLEGRIDY launch
• Started booking revenues in Germany at a lower price in
mid-February 2015
• Approximately 2.5 weeks of inventory in the wholesale
channel, a similar level to last quarter
Note: Numbers may not foot due to rounding
• FX, offset by hedging, weakened TECFIDERA revenue by
approximately $8 million for Q1 2015 versus prior quarter
and strengthened revenue by approximately $2 million
versus Q1 2014
16
Global Interferon Performance
Interferon Revenues ($M)
Q1 2015 Highlights
• Total Interferon Revenue vs. Q4 2014 & Q1 2014
$761
$774
$745
$3
$285
$276
$260
$777
$13
WW
US
ROW
$755
$22
$235
$214
$28
$40
$498
$482
$501
$479
Q1-14
Q2-14
Q3-14
Q4-14
Q1-15
and
and
and
-1%
+9%
-17%
• In US, 14 shipping weeks in Q4 2014 and 13 in all
other quarters shown
PLEG ROW
$476
-3%
-2%
-5%
AVX ROW
• AVONEX + PLEGRIDY combined gained share
versus prior quarter amongst interferons
PLEG US
• PLEGRIDY continues to source patients broadly
AVX US
• FX, offset by hedging, weakened interferon revenue
by approximately $12 million in Q1 2015 versus prior
quarter and by approximately $25 million versus Q1
2014
Note: Numbers may not foot due to rounding
17
Global TYSABRI Performance
4th Consecutive Quarter of
Positive Net New Patient Adds
TYSABRI Revenue ($M)
Q1 2015 Highlights
• Revenue vs. Q4 2014 & Q1 2014
$533
$501
$484
$441
1
$284
$226
$207
$218
WW
US
ROW
$463
$190
$250
$275
Q1-14
Q2-14
Q3-14
$266
$273
US
Q4-14
and
and
and
+5%
+16%
-8%
• In the US, there were 13 shipping weeks in Q1 2015
versus 12 in Q1 2014, 13 in Q2 2014, 14 in Q3 2014,
and 13 in Q4 2014
ROW
$234
-4%
+3%
-13%
Q1-15
• Physicians continue to choose this therapy for patients
requiring high efficacy
• FX, offset by hedging, weakened TYSABRI revenue
by approximately $12 million for Q1 2015 versus prior
quarter and by approximately $20 million versus Q1
2014
1 Q2’14
TYSABRI sales outside the U.S. included $54 million of previously deferred
revenue from February 2013 through March 31, 2014, which was recognized during
Q2’14 following an agreement with AIFA. Beginning in the second quarter of 2014, we
recorded TYSABRI revenues in Italy at the full reimbursed price.
Note: Numbers may not foot due to rounding
18
ALPROLIX Performance
ALPROLIX Revenue ($M)
Q1 2015 Highlights
• Continued to gain new patients
$40
$43
$2
• ROW revenues primarily from Japan
$4
• Anticipate filing MAA for ALPROLIX in the EU during
the 2H15
$25
$0.2
$37
$10
$41
ROW
• Positive pediatric Kids B-LONG study readout
February, 2015; PUPs* study currently enrolling
US
$25
$10
Q2-14
Q3-14
Q4-14
Q1-15
Note: Numbers may not foot due to rounding
* Previously untreated patients
19
ELOCTATE Performance
ELOCTATE Revenue ($M)
Q1 2015 Highlights
$54
• Continued to gain new patients
$0.4
• Launched in Japan
• ELOCTA (trade name in the EU) filed for marketing
authorization in EU
$37
ROW
$53
$22
$37
• Data presented at 8th European Association for
Haemophilia and Allied Disorders Conference
$22
Q3-14
Q4-14
US
• Positive pediatric Kids A-LONG study readout April,
2014; PUPs* study currently enrolling
Q1-15
– Interim data from ASPIRE, an open label
extension from the pivotal A-LONG study, help
show maintenance of a low ABR with extended
prophylactic dosing intervals in patients with
severe hemophilia A, and help demonstrate the
safety and efficacy of rFVIIIFc treatment was
consistent with the A-Long study.
Note: Numbers may not foot due to rounding
* Previously untreated patients
20
Financial Update
Paul Clancy
EVP, Chief Financial Officer
21
Q1 2015 GAAP to Non-GAAP Reconciliation
Q1 2015
GAAP Diluted EPS
$3.49
GAAP Net Income Attributable to Biogen Inc. ($M)
$822.5
Amortization of Acquired Intangibles ($M)
92.5
Contingent Consideration ($M)
7.8
Tax Impact ($M)
Total Adjustments ($M)
(22.6)
77.7
Non-GAAP Net Income Attributable to Biogen Inc. ($M)
$900.2
Non-GAAP Diluted EPS
$3.82
Numbers may not foot due to rounding
22
Q1 2015 Financial Results Summary: Revenues 1 of 2
Q1 2014
Q4 2014
Q1 2015
 Q/Q
 Y/Y
TECFIDERA US
$460
$743
$648
(13%)
41%
TECFIDERA ROW
$46
$173
$177
2%
285%
Total TECFIDERA Sales1
$506
$916
$825
(10%)
63%
AVONEX US
$476
$501
$479
(4%)
1%
AVONEX ROW
$285
$235
$214
(9%)
(25%)
Total AVONEX Sales1
$761
$736
$693
(6%)
(9%)
PLEGRIDY US
$0
$28
$40
42%
NMF
PLEGRIDY ROW
$0
$13
$22
68%
NMF
Total PLEGRIDY Sales
$0
$41
$62
50%
NMF
Total Interferon Sales
$761
$777
$755
(3%)
(1%)
TYSABRI US
$234
$266
$273
3%
16%
TYSABRI ROW
$207
$218
$190
(13%)
(8%)
Total TYSABRI Sales1
$441
$484
$463
(4%)
5%
FAMPYRA
$19
$19
$20
8%
6%
$1,727
$2,195
$2,062
(6%)
19%
$ in Millions
Total MS Sales
Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).
For all periods, there were no adjustments between GAAP and non-GAAP revenues
1 Net of Hedge
23
Q1 2015 Financial Results Summary: Revenues 2 of 2
Q1 2014
Q4 2014
Q1 2015
 Q/Q
 Y/Y
ALPROLIX US
$0
$37
$41
12%
NMF
ALPROLIX ROW
$0
$4
$2
(45%)
NMF
Total ALPROLIX Sales
$0
$40
$43
7%
NMF
ELOCTATE US
$0
$37
$53
44%
NMF
ELOCTATE ROW
$0
$0
$0.4
NMF
NMF
Total ELOCTATE Sales
$0
$37
$54
45%
NMF
Total Hemophilia Sales
$0
$77
$97
25%
NMF
FUMADERM Sales
$16
$14
$14
(6%)
(13%)
Total Product Sales
$1,743
$2,287
$2,172
(5%)
25%
RITUXAN/GAZYVA US Profit Share1
$275
$286
$310
8%
13%
RITUXAN ROW Royalty
$22
$19
$21
14%
(5%)
Unconsolidated Joint Business Revenue
(RITUXAN & GAZYVA)
$297
$305
$331
9%
11%
Corporate Partner Revenues
$52
$18
$32
81%
(38%)
Royalties
$38
$31
$20
(37%)
(48%)
$2,130
$2,641
$2,555
(3%)
20%
$ in Millions
Total Revenue
Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).
For all periods, there were no adjustments between GAAP and non-GAAP revenues
1 US Profit Share = US Profit Share + Expense Reimbursement
24
RITUXAN and GAZYVA Performance
RITUXAN and GAZYVA Results ($M)
$917
$891
$876
$285 $303
$275 $297
$22
Q1-14
Q2-14
1,2
ROW Royalty
$21
$19
Q3-14
BIIB US Profit Share
$310 $331
$286 $305
$271 $291
$20
$18
$956
$872
Q4-14
BIIB Revenue
2
Q1-15
US Net Sales
Q1 2015 Highlights
• Revenue vs. Q4 2014 and Q1 2014
US Net Sales
US Profit Share1,2
ROW Royalty
BIIB Revenue2
+10%
+8%
+14%
+9%
and
and
and
and
+9%
+13%
-5%
+11%
• Positive results for GAZYVA Ph. 3 GADOLIN trial in refractory
iNHL in February, 2015
• Ongoing Ph. 3 trials for GAZYVA in DLBCL and first-line iNHL
Note: In collaboration with Roche and Genentech. Numbers may not foot due to rounding.
1 BIIB US Profit Share = US Profit Share + Expense Reimbursement
2 US profit share and BIIB revenue were reduced by approximately $21 million in Q3’14 due to expense related to the Branded Prescription Drug Fee.
Note: Numbers may not foot due to rounding
25
Q1 2015 Financial Results Summary
Q1 2014
Q4 2014
Q1 2015

Q/Q

Y/Y
$279
$297
$312
(5%)
(12%)
13%
11%
12%
$527
$499
$461
8%
13%
25%
19%
18%
$509
$573
$560
2%
(10%)
24%
22%
22%
Amortization of Acquired
Intangibles4
$3
$6
$3
42%
NMF
Gain on Sale of Rights
(BENLYSTA)
$4
$5
$0
(100%)
(100%)
$ in Millions
Cost of Sales1
% of Total Revenues
Non-GAAP R&D Expenses2
% of Total Revenues
Non-GAAP SG&A Expenses3
% of Total Revenues
Note: Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).
1 For all periods there were no adjustments between GAAP and non-GAAP cost of sales.
2 For Q1’14 GAAP R&D expense was $529 million and 25% of Total Revenues, non-GAAP R&D expense excludes $2 million in stock option expense. For
Q4‘14 GAAP R&D expense was $500 million and 19% of Total Revenues, non-GAAP R&D expense excludes $1 million in stock option expense. For Q1‘15
there were no adjustments between GAAP and non-GAAP R&D expense.
3 For Q1'14 GAAP SG&A expense was $512 million and 24% of Total Revenues, non-GAAP SG&A expense excludes $3 million in stock option expense. For
Q4’14 GAAP SG&A expense was $574 million and 22% of Total Revenues, non-GAAP SG&A expense excludes $1 million in stock option expense. For Q1’15
there were no adjustments between GAAP and non-GAAP SG&A expense.
4 For Q1’14 GAAP Amortization was $143 million, non-GAAP Amortization excludes $140 million of amortization related to acquired intangible assets. For
Q4’14 GAAP Amortization was $107 million, non-GAAP Amortization excludes $101 million of amortization related to acquired intangible assets. For Q1’15
GAAP Amortization was $96 million, non-GAAP Amortization excludes $92 million of amortization related to acquired intangible assets.
26
Q1 2015 Financial Results Summary
$ in Millions except EPS
Shares in millions
Q1 2014
Q4 2014
Q1 2015
 Q/Q
 Y/Y
Other income (expense), net1
($6)
($9)
($15)
(71%)
(168%)
Non-GAAP Tax Rate2
27%
24%
25%
Equity in Loss of Investee, net of tax3
$8
$0
$1
NMF
89%
Net Income (Loss) Attributable to Non Controlling Interest
$0
($1)
($2)
NMF
NMF
Non-GAAP Net Income attributable to Biogen4
$587
$966
$900
(7%)
53%
Weighted average diluted shares used in calculating
diluted EPS
238
236
236
0%
1%
$2.47
$4.09
$3.82
(7%)
55%
Non-GAAP EPS4
Note: Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).
1 For all periods other income (expense), net there were no adjustments between GAAP and non-GAAP.
2 GAAP tax rates were 27%, 23%, and 26% for Q1’14, Q4'14, and Q1’15, respectively. The difference between the GAAP and non-GAAP tax rate for all periods is a
result of the cumulative effects of the reconciliation that can be found at the end of this presentation and the footnotes to the prior slide of this presentation.
3 Represents our share of the results of operations related to our investment in Samsung Bioepis.
4 GAAP diluted EPS were $2.02, $3.74, and $3.49 in Q1’14, Q4'14, and Q1’15, respectively. GAAP net income attributable to Biogen Inc. was $480 million, $883
million and $823 million in Q1’14, Q4'14, and Q1’15, respectively. Please refer to the end of this presentation for the most directly comparable GAAP net income
attributable to Biogen Inc. and diluted GAAP EPS, with a reconciliation to the non-GAAP net income attributable to Biogen Inc. and diluted non-GAAP EPS.
27
Closing Remarks
George Scangos, Ph.D.
Chief Executive Officer
28
Biogen: Focused on Execution
•
Continued focus on MS portfolio
•
Initiating multiple Phase 3 trials in Alzheimer's disease and
SPMS
•
Multiple upcoming potential value drivers expected
– Phase 3 for TYSABRI in secondary progressive MS (H2 2015)
– Phase 2 for TYSABRI in acute ischemic stroke (mid 2015)
– Phase 2 for Neublastin for neuropathic pain (mid 2015)
29
Questions & Answers
30
Biogen
Appendix
31
Neurology Late Stage Programs
Molecule
ISIS-SMNRx1
ISIS-SMNRx1
TYSABRI
ZINBRYTA2
Trial Name
ENDEAR
CHERISH
ASCEND
DECIDE
OPERA I
OPERA II
ORATORIO
Phase
Phase III
Phase III
Phase IIIb
Phase III
Phase III
Phase III
Phase III
Indication
Infantile-onset
Spinal
Muscular
Atrophy (SMA)
Later-onset
Spinal Muscular
Atrophy (SMA)
SPMS
RMS
RMS
RMS
PPMS
Administration
Intrathecal
injection
Intrathecal
injection
IV/Infusion
SC Injection
IV/Infusion
IV/Infusion
IV/Infusion
Target
Enrollment
110
120
850
1,800
800
800
630
12mg intrathecal
injection versus
sham procedure
1.Placebo
2.300 mcg IV every
4 wks
Active
comparator
trial versus Ifn
β 1-A
Active
comparator
trial vs. Ifn β 1A (Rebif)
Active
comparator trial
vs. Ifn β 1-A
(Rebif)
Placebo
comparator
Time to death
or permanent
ventilation
Hammersmith
Functional
Motor ScaleExpanded
(HFMSE)
Proportion of
subjects
experiencing
confirmed
progression of
disability as
measured by a
composite endpoint
ARR at 2-3
years
ARR at 96
Weeks
ARR at 96
Weeks
Time to
sustained
disability
progression
Currently
enrolling
Currently
enrolling
Data readout
expected H2 2015
Filed in EU
Enrollment
completed Q1
2013
Enrollment
completed Q1
2013
Enrollment
completed Q1
2013
12mg
intrathecal
injection
versus sham
procedure
Design
Primary
Endpoint
Status
OCRELIZUMAB2
1
Collaboration with Isis Pharmaceuticals.
Collaboration with AbbVie Biotherapeutics.
3 Genentech has responsibility for, and is funding 100% of, the further development of ocrelizumab in multiple sclerosis and will be responsible for commercialization.
2
32
Hemophilia Late Stage Programs
Molecule
ALPROLIX
ELOCTATE
Trial Name
B-LONG
KIDS B-LONG
A-LONG
KIDS A-LONG
Phase
Phase III
Phase III
Phase III
Phase III
Indication
Hemophilia B
Hemophilia B
Hemophilia A
Hemophilia A
Administration
IV Infusion
IV Infusion
IV Infusion
IV Infusion
Target Enrollment
123
~20
~150
~50
Prophylaxis Regimen
Individualized
Prophylaxis
Weekly Prophylaxis
On-demand Treatment
Perioperative
Management
Prophylaxis Regimen
Design
Weekly Prophylaxis
Individualized Interval
Prophylaxis
On-demand Treatment
Perioperative
Management
Key Endpoints
Inhibitor Incidence
Annualized Bleeding Rate
Response to Treatment
Inhibitor Incidence
Annualized Bleeding Rate
Response to Treatment
Inhibitor Incidence
Annualized Bleeding Rate
Response to Treatment
Inhibitor Incidence
Annualized Bleeding Rate
Response to Treatment
Status
Study Complete
FDA Approved
Approved in Japan
Study Complete
Data Released February
2015
Study Complete
FDA Approved
ELOCTA filed in EU
Approved in Japan
Study Complete
Data Released April 2014
33
Anti-CD20 Late Stage Programs
Molecule
GAZYVA
Trial Name
GOYA
GADOLIN
GALLIUM
Phase
Phase III
Phase III
Phase III
Indication
Front-line Diffuse Large
B-cell lymphoma
(DLBCL)
Rituxan-refractory
indolent Non Hodgkin’s
Lymphoma (iNHL)
w/maintenance
Front-line iNHL
w/maintenance
Administration
IV Infusion
IV Infusion
IV Infusion
Target Enrollment
1,418
411
1,401
Design
Arm A: GAZYVA plus
CHOP
Arm B: RITUXAN plus
CHOP
Arm A: GAZYVA plus
Bendamustine followed
by GAZYVA maintenance
Arm B: Bendamustine
Arm A: GAZYVA plus
chemotherapy followed
by GAZYVA maintenance
Arm B: RITUXAN plus
chemotherapy followed
by RITUXAN
maintenance
Primary Endpoint
Progression-free survival
Progression-free survival
Progression-free survival
Recruitment completed
Q2 2014
Trial stopped at interim
for efficacy Q1 2015
Trial continues after
interim analysis in 2015
Data to be presented at
ASCO 2015
Final data expected in
2016
Expect global filing in
2015
Status
Recruitment completed
Expect data in 2017
Note: In collaboration with, and operationalized by, Roche.
34
Q1 2015 Impact of Foreign Exchange
Compared with the Same Quarter of Last Year
FX / Hedge Impact
Favorable / (Unfavorable)
Q1 2015
Total Revenue
$2,555
$(49)*
(2)%
Cost of Sales
$312
$6
2%
Non-GAAP R&D Expenses
$461
$7
1%
Non-GAAP SG&A Expenses
$560
$20
4%
Note: Amounts are in ($) Millions. See end of this presentation for a reconciliation of our GAAP to non-GAAP R&D and SG&A expenses
*Total revenue excluding the $40 million gain from hedging was lower by $89 million in the current period versus a year ago due to foreign exchange rates.
Numbers may not foot due to rounding.
35
Q1 2015 Impact of Foreign Exchange
Compared with Prior Quarter
FX / Hedge Impact
Favorable / (Unfavorable)
Q1 2015
Total Revenue
$2,555
$(34)*
(1)%
Cost of Sales
$312
$1
0%
Non-GAAP R&D Expenses
$461
$5
1%
Non-GAAP SG&A Expenses
$560
$12
2%
Note: Amounts are in ($) Millions. See end of this presentation for a reconciliation of our GAAP to non-GAAP R&D and SG&A expenses
*Total revenue excluding the $21 million gain from hedging was lower by $55 million in the current period versus prior quarter due to foreign exchange rates.
Numbers may not foot due to rounding.
36
GAAP to non-GAAP reconciliation
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
Ended March 31,
2015
GAAP earnings per share - Diluted
Adjustments to GAAP net income attributable to Biogen Inc. (as detailed below)
Non-GAAP earnings per share - Diluted
$
$
3.49
0.33
3.82
2014
$
2.02
0.45
2.47
$
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
Ended March 31,
2015
GAAP net income attributable to Biogen Inc.
Adjustments:
Amortization of acquired intangible assets
(Gain) loss on fair value remeasurement of contingent consideration
SG&A: Stock option expense
R&D: Stock option expense
Income tax effect related to reconciling items
Non-GAAP net income attributable to Biogen Inc.
$
822.5
$
92.5
7.8
(22.6)
900.2
2014
$
480.0
$
139.8
(0.8)
2.6
2.3
(37.0)
586.9
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 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
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.
37