RBC On BIIB 0617
RBC On BIIB 0617
RBC On BIIB 0617
Adnan Butt
(Analyst)
(415) 633-8588
adnan.butt@rbccm.com
Sector: Biotechnology
Key points:
Clinicaltrials.gov changed the Phase III Tysabri SPMS estimated study
completion date to June 2015, so data could be released this summer
vs. expectations for later this year and old status suggesting Fall '15.
This is consistent with the enrollment completed in July 2013, so twoyear treatment protocol implies that all patients are done by next month.
Bottom line is expectations are very low on Tysabri and we see a 3035%
probability of success (vs. buyside consensus 2025% or lower), which
would lead to up to $12B revenue upside and $4 or more of EPS accretion
(royalty is also paid out to PRGO). Thus, $4 accretion x 20 P/E multiple
implies up to $80 or 20% upside to the stock value over time, which
isn't unreasonable given a new growth driver for this pipeline stock. We
see some modest 15%+ chance of a "mixed" result, e.g., a big subset of
"responders" gets great benefit and BIIB might still try to file with FDA
given the unmet medical need. We see 50% probability there's not enough
signal to file but minimal downside given it's not in Street estimates
because it's viewed as a high-risk study. Bottom line is we like BIIB also
for upcoming Alzheimer's data in July as well as more pipeline catalysts
coming including LINGO in early 2016.
Outperform
NASDAQ: BIIB; USD 388.28
Price Target USD 525.00
WHAT'S INSIDE
Rating/Risk Change
In-Depth Report
Est. Change
Preview
News Analysis
Scenario Analysis*
Downside
Scenario
Current
Price
Price
Target
Upside
Scenario
314.00
19%
388.28
525.00
35%
565.00
46%
Key Statistics
Shares O/S (MM):
Dividend:
235.6
0.00
91,479
0.0%
1,274,706
RBC Estimates
FY Dec
EPS, Ops Diluted
P/E
Revenue
EPS, Ops Diluted
2014
2015
Revenue
2014
2015
2014A
2015E
2016E
2017E
13.83
16.65
19.30
22.07
28.1x
23.3x
20.1x
17.6x
9,703.0 10,997.0 12,060.0 12,904.0
Q1
2.47A
3.82A
Q2
3.49A
4.06E
Q3
3.80A
4.36E
Q4
4.09A
4.43E
Priced as of prior trading day's market close, EST (unless otherwise noted).
Biotechnology
Biogen Idec Inc.
Target/Upside/Downside Scenarios
Investment summary
23JAN13 - 16JUN15
UPSIDE
TARGET
CURRENT
540
440
390
340
565.00
525.00
388.28
DOWNSIDE 314.00
290
240
190
140
20m
15m
10m
5m
2013
2014
2015
J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J
BIIB
Jun 2016
MA 40 weeks
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
Phase III, multicenter, international, randomized, double-blind, placeboThe proportion of subjects experiencing confirmed progression of
disability as measured by a composite endpoint (Expanded Disability
Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test
(9HPT)
SPMS 2 years with EDSS 3.0 to 6.5 (inclusive)
RRMS & PPMS
June 2015
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
2.
In a retrospective analysis of two Phase I and II clinical trials of Tysabri in SPMS patients,
an improvement in walking was observed as assessed by the timed 25-foot walk
(T25FW) test. Even though this ad-hoc analysis is limited by the small sample size and
short duration of therapy, if these observations play out in the Phase III study, it would
increase the chance of hitting the primary endpoint as it is a composite endpoint that
includes the T25FW test.
3.
KOLs indicate that Tysabri is used widely off-label for SPMS already. Based on our
discussion with various KOLs, up to 15% of Tysabri use is for SPMS patients, as this is the
best option they have so far. In order to get around the reimbursement hurdle, docs
mentioned that these patients are diagnosed as RRMS so that reimbursement can be
approved. In terms of the Phase III ASCEND study, physicians generally agreed that there
is good chance for it to hit on the T25W endpoint.
4.
Mild EDSS entry criteria may also increase chance of Tysabri showing a benefit. One of
the key inclusion criteria for the ASCEND study is the EDSS score of 3.0 to 6.5. Baseline
data indicate that approximately one-third of enrolled patients have EDSS score
between 3.0 and 5.5. These patients are generally milder SPMS patients who do not
require assistance for walking. KOLs believed that these milder patients are more likely
to have inflammatory lesions, which is the mechanism that Tysabri targets. Thus, we
believe Tysabri is more likely to benefit these milder patients and potentially show a
meaningful difference in the T25FW or EDSS endpoint.
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
The ability of T lymphocytes to migrate across the blood-brain barrier and infiltrate the
brain is dependent on the interplay between very late antigen-4 (VLA-4) and vascular cell
adhesion molecule-1 (VCAM-1) on endothelial cells. Therefore, agents that modify VLA-4
function may have an effect in treating acute ischemic stroke. Tysabri (natalizumab), a
humanized monoclonal antibody used in treating multiple sclerosis and Crohnss disease, can
block VLA-4, and thus it may also be effective at treating acute ischemic stroke. However,
there are contradictory animal studies on the effectiveness of treating stroke through
inhibiting T cell migration across the blood-brain barrier.
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
Valuation
Our $525 price target is based on a 26.6x P/E our 2016E EPS. This is also possible based on
DCF analysis that values the base business ($314/share) including Tecfidera and hemophilia
programs. For various pipeline programs, we add probability adjusted value of $211/sh total
for Tysabri SPMS, ANTI-LINGO, BIIB037 (5060% POS), $SMNrx, IPF, and ANTI-TWEAK.
Company description
Biogen Idec is one of the world's leading biotech companies, with a focus on neurology,
oncology, and autoimmune diseases. The company's key products include Rituxan for nonHodgkin's lymphoma, Avonex for multiple sclerosis, and Tysabri for multiple sclerosis. Biogen
has significant manufacturing capabilities and an extensive worldwide sales and marketing
infrastructure.
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
FYA
2012
Avonex + Plegridy
Tecfidera
Rituxan + Gazyva
Tysabri - US Transfer revenue
Tysabri - US revenue
Tysabri - Ex-US sales
Fampyra - Ex-US sales
Eloctate
Alprolix
Oral fumarate (Psoriasis)
2,913
FYA
2013
1QA
Mar-14
2QA
Jun-14
3QA
Sep-14
4QA
Dec-14
FYA
2014
1QA
Mar-15
60
78
186
6,932
858
1,323
1,273
318
85
3,469
4,104
1,318
1,282
1,291
1,375
5,266
1,337
1,461
1,486
1,543
5,827
6,312
6,613
Operating Income
2,091
2,845
808
1,143
1,224
1,271
4,447
1,218
1,284
1,344
1,333
5,179
5,766
6,314
36
67
2,511
303
18
31
2,641
297
128
177
9,703
1,171
1,440
527
446
416
499
1,707
509
540
569
573
FYE
2017
44
169
5,516
545
2,090
22
40
2,421
292
FYE
2016
60
Pretax Income
52
38
2,130
279
FYE
2015
1,138
388
748
57
-
(1)
3,058
2,909
1,195
1,025
935
80
58
76
62
4QE
Dec-15
761
506
297
234
207
19
-
777
916
305
266
218
19
37
40
14
3QE
Sep-15
3,005
876
1,127
113
701
713
74
-
745
787
291
275
226
20
22
25
17
755
825
331
273
190
20
54
16
774
700
303
250
283
22
10
16
2QE
Jun-15
(8)
2,837
(6)
803
5
1,148
(16)
1,208
(9)
1,262
14
769
907
342
285
245
22
70
48
15
766
978
343
290
235
24
80
53
18
752
1,035
359
285
220
24
85
55
18
3,041
3,745
1,374
1,133
890
90
289
199
65
3,080
4,301
1,424
1,201
985
98
400
225
76
3,150
4,749
1,514
1,261
1,050
105
475
250
80
32
20
2,555
312
20
20
2,742
334
20
20
2,827
338
20
20
2,873
334
92
80
10,997
1,318
80
190
12,060
1,416
80
190
12,904
1,504
1,888
461
521
537
603
2,122
2,352
2,516
2,191
560
603
608
603
2,375
2,533
2,581
(26)
4,421
(17)
1,201
(3)
1,281
(3)
1,341
(3)
1,330
(25)
(10)
5,154
5,756
5
6,319
524
694
215
309
304
297
1,125
304
333
335
319
1,292
1,381
1,428
Net Income
1,566
2,136
587
838
899
965
3,288
897
948
1,006
1,011
3,863
4,374
4,891
1,566
2,136
587
829
900
966
3,281
900
948
1,006
1,011
3,863
4,374
4,891
$6.58
$9.01
$2.48
$3.50
$3.81
$4.10
$13.91
$3.82
$4.08
$4.38
$4.45
$16.71
$19.38
$22.20
$6.53
$8.96
$2.47
$3.49
$3.80
$4.09
$13.83
$3.82
$4.06
$4.36
$4.43
$16.65
$19.30
$22.07
238.0
236.9
236.8
236.7
236.2
235.5
236.4
235.0
232.4
229.8
227.3
231.1
225.7
220.3
239.7
238.3
237.8
237.4
237.0
236.3
237.2
235.6
233.4
230.8
228.3
232.0
226.7
221.6
FYA
FYA
1QA
2QA
3QA
4QA
FYA
1QA
2QE
3QE
4QE
FYE
FYE
FYE
2012
2013
Mar-14
Jun-14
Sep-14
Dec-14
2014
Mar-15
Jun-15
Sep-15
Dec-15
2015
2016
2017
Avonex
US
1,794
1,902
476
498
482
501
1,957
479
484
469
446
1,878
1,600
RoW
1,119
1,104
285
276
260
235
1,056
214
208
203
199
824
880
800
2,913
3,006
761
774
745
777
3,057
755
769
766
752
3,042
3,080
3,150
866
460
585
638
743
2,426
648
712
760
800
4,392
3,270
3,532
10
46
115
149
173
483
177
195
218
235
921
1,031
1,217
876
506
700
787
916
2,909
825
907
978
1,035
5,313
4,301
4,749
US
885
958
234
250
275
266
1,025
273
285
290
285
1,133
1,201
1,261
RoW
745
715
207
284
226
218
935
190
245
235
240
910
985
1,050
1,630
1,673
441
534
501
484
1,960
463
530
525
525
2,043
2,186
2,311
Worldwide Sales
1,500
Tecfidera
US
RoW
Worldwide Sales
Tysabri
Worldwide Sales
2012
2013
Mar-14
Jun-14
Sep-14
Dec-14
2014
Mar-15
Jun-15
Sep-15
Dec-15
2015
2016
9%
26%
50%
40%
37%
34%
40%
20%
13%
13%
9%
13%
10%
2017
7%
11%
37%
25%
52%
61%
74%
54%
55%
16%
15%
8%
20%
16%
14%
Note: Sales summary for Tysabri is reported sales; Biogen books US transfer revenues in income statement above which differs from actual reported sales
Source: Company reports and RBC Capital Markets estimates.
Michael J. Yee,
Biotechnology
Biogen Idec Inc.
Required disclosures
Conflicts disclosures
The analyst(s) responsible for preparing this research report received compensation that is based upon various factors, including
total revenues of the member companies of RBC Capital Markets and its affiliates, a portion of which are or have been generated
by investment banking activities of the member companies of RBC Capital Markets and its affiliates.
Please note that current conflicts disclosures may differ from those as of the publication date on, and as set forth in,
this report. To access current conflicts disclosures, clients should refer to https://www.rbccm.com/GLDisclosure/PublicWeb/
DisclosureLookup.aspx?entityId=1 or send a request to RBC CM Research Publishing, P.O. Box 50, 200 Bay Street, Royal Bank Plaza,
29th Floor, South Tower, Toronto, Ontario M5J 2W7.
RBC Capital Markets, LLC makes a market in the securities of Biogen Idec Inc..
RBC Capital Markets is currently providing Biogen Idec Inc. with non-securities services.
Distribution of ratings
For the purpose of ratings distributions, regulatory rules require member firms to assign ratings to one of three rating categories
- Buy, Hold/Neutral, or Sell - regardless of a firm's own rating categories. Although RBC Capital Markets' ratings of Top Pick(TP)/
Outperform (O), Sector Perform (SP), and Underperform (U) most closely correspond to Buy, Hold/Neutral and Sell, respectively,
the meanings are not the same because our ratings are determined on a relative basis (as described below).
Distribution of ratings
RBC Capital Markets, Equity Research
As of 31-Mar-2015
Investment Banking
Serv./Past 12 Mos.
Rating
BUY [Top Pick & Outperform]
HOLD [Sector Perform]
SELL [Underperform]
Count
Percent
Count
Percent
909
713
115
52.33
41.05
6.62
280
125
5
30.80
17.53
4.35
Michael J. Yee,
10
Biotechnology
Biogen Idec Inc.
References to a Recommended List in the recommendation history chart may include one or more recommended lists or model
portfolios maintained by RBC Wealth Management or one of its affiliates. RBC Wealth Management recommended lists include
the Guided Portfolio: Prime Income (RL 6), the Guided Portfolio: Large Cap (RL 7), the Guided Portfolio: Dividend Growth (RL 8),
the Guided Portfolio: Midcap 111 (RL 9), the Guided Portfolio: ADR (RL 10), and the Guided Portfolio: Global Equity (U.S.) (RL 11).
RBC Capital Markets recommended lists include the Strategy Focus List and the Fundamental Equity Weightings (FEW) portfolios.
The abbreviation 'RL On' means the date a security was placed on a Recommended List. The abbreviation 'RL Off' means the date
a security was removed from a Recommended List.
Conflicts policy
RBC Capital Markets Policy for Managing Conflicts of Interest in Relation to Investment Research is available from us on request.
To access our current policy, clients should refer to
https://www.rbccm.com/global/file-414164.pdf
or send a request to RBC Capital Markets Research Publishing, P.O. Box 50, 200 Bay Street, Royal Bank Plaza, 29th Floor, South
Tower, Toronto, Ontario M5J 2W7. We reserve the right to amend or supplement this policy at any time.
Michael J. Yee,
11
Biotechnology
Biogen Idec Inc.
'Sector Perform' or even an 'Underperform' might present a short-term buying opportunity as a result of temporary selling pressure
in the market; conversely, a subject company's common equity rated a long-term 'Outperform' could be considered susceptible
to a short-term downward price correction. Short-term trade ideas are not ratings, nor are they part of any ratings system, and
the firm generally does not intend, nor undertakes any obligation, to maintain or update short-term trade ideas. Short-term trade
ideas may not be suitable for all investors and have not been tailored to individual investor circumstances and objectives, and
investors should make their own independent decisions regarding any securities or strategies discussed herein. Please contact
your investment advisor or institutional salesperson for more information regarding RBC Capital Markets' research.
Analyst certification
All of the views expressed in this report accurately reflect the personal views of the responsible analyst(s) about any and all of
the subject securities or issuers. No part of the compensation of the responsible analyst(s) named herein is, or will be, directly or
indirectly, related to the specific recommendations or views expressed by the responsible analyst(s) in this report.
The Global Industry Classification Standard (GICS) was developed by and is the exclusive property and a service mark of MSCI Inc. (MSCI) and Standard & Poors Financial Services
LLC (S&P) and is licensed for use by RBC. Neither MSCI, S&P, nor any other party involved in making or compiling the GICS or any GICS classifications makes any express or implied
warranties or representations with respect to such standard or classification (or the results to be obtained by the use thereof), and all such parties hereby expressly disclaim all warranties
of originality, accuracy, completeness, merchantability and fitness for a particular purpose with respect to any of such standard or classification. Without limiting any of the foregoing,
in no event shall MSCI, S&P, any of their affiliates or any third party involved in making or compiling the GICS or any GICS classifications have any liability for any direct, indirect, special,
punitive, consequential or any other damages (including lost profits) even if notified of the possibility of such damages.
Disclaimer
RBC Capital Markets is the business name used by certain branches and subsidiaries of the Royal Bank of Canada, including RBC Dominion Securities Inc., RBC
Capital Markets, LLC, RBC Europe Limited, RBC Capital Markets (Hong Kong) Limited, Royal Bank of Canada, Hong Kong Branch and Royal Bank of Canada, Sydney
Branch. The information contained in this report has been compiled by RBC Capital Markets from sources believed to be reliable, but no representation or warranty,
express or implied, is made by Royal Bank of Canada, RBC Capital Markets, its affiliates or any other person as to its accuracy, completeness or correctness. All
opinions and estimates contained in this report constitute RBC Capital Markets' judgement as of the date of this report, are subject to change without notice and
are provided in good faith but without legal responsibility. Nothing in this report constitutes legal, accounting or tax advice or individually tailored investment
advice. This material is prepared for general circulation to clients and has been prepared without regard to the individual financial circumstances and objectives of
persons who receive it. The investments or services contained in this report may not be suitable for you and it is recommended that you consult an independent
investment advisor if you are in doubt about the suitability of such investments or services. This report is not an offer to sell or a solicitation of an offer to buy
any securities. Past performance is not a guide to future performance, future returns are not guaranteed, and a loss of original capital may occur. RBC Capital
Markets research analyst compensation is based in part on the overall profitability of RBC Capital Markets, which includes profits attributable to investment banking
revenues. Every province in Canada, state in the U.S., and most countries throughout the world have their own laws regulating the types of securities and other
investment products which may be offered to their residents, as well as the process for doing so. As a result, the securities discussed in this report may not be
eligible for sale in some jurisdictions. RBC Capital Markets may be restricted from publishing research reports, from time to time, due to regulatory restrictions and/
or internal compliance policies. If this is the case, the latest published research reports available to clients may not reflect recent material changes in the applicable
industry and/or applicable subject companies. RBC Capital Markets research reports are current only as of the date set forth on the research reports. This report is
not, and under no circumstances should be construed as, a solicitation to act as securities broker or dealer in any jurisdiction by any person or company that is not
legally permitted to carry on the business of a securities broker or dealer in that jurisdiction. To the full extent permitted by law neither RBC Capital Markets nor
any of its affiliates, nor any other person, accepts any liability whatsoever for any direct or consequential loss arising from any use of this report or the information
contained herein. No matter contained in this document may be reproduced or copied by any means without the prior consent of RBC Capital Markets.
Additional information is available on request.
To U.S. Residents:
This publication has been approved by RBC Capital Markets, LLC (member FINRA, NYSE, SIPC), which is a U.S. registered broker-dealer and which accepts
responsibility for this report and its dissemination in the United States. Any U.S. recipient of this report that is not a registered broker-dealer or a bank acting in
a broker or dealer capacity and that wishes further information regarding, or to effect any transaction in, any of the securities discussed in this report, should
contact and place orders with RBC Capital Markets, LLC.
To Canadian Residents:
This publication has been approved by RBC Dominion Securities Inc.(member IIROC). Any Canadian recipient of this report that is not a Designated Institution in
Ontario, an Accredited Investor in British Columbia or Alberta or a Sophisticated Purchaser in Quebec (or similar permitted purchaser in any other province) and
that wishes further information regarding, or to effect any transaction in, any of the securities discussed in this report should contact and place orders with RBC
Dominion Securities Inc., which, without in any way limiting the foregoing, accepts responsibility for this report and its dissemination in Canada.
To U.K. Residents:
This publication has been approved by RBC Europe Limited ('RBCEL') which is authorized by the Prudential Regulation Authority and regulated by the Financial
Conduct Authority ('FCA') and the Prudential Regulation Authority, in connection with its distribution in the United Kingdom. This material is not for general
distribution in the United Kingdom to retail clients, as defined under the rules of the FCA. However, targeted distribution may be made to selected retail clients of
RBC and its affiliates. RBCEL accepts responsibility for this report and its dissemination in the United Kingdom.
To Persons Receiving This Advice in Australia:
This material has been distributed in Australia by Royal Bank of Canada - Sydney Branch (ABN 86 076 940 880, AFSL No. 246521). This material has been prepared
for general circulation and does not take into account the objectives, financial situation or needs of any recipient. Accordingly, any recipient should, before acting on
this material, consider the appropriateness of this material having regard to their objectives, financial situation and needs. If this material relates to the acquisition
Michael J. Yee,
12
Biotechnology
Biogen Idec Inc.
or possible acquisition of a particular financial product, a recipient in Australia should obtain any relevant disclosure document prepared in respect of that product
and consider that document before making any decision about whether to acquire the product. This research report is not for retail investors as defined in section
761G of the Corporations Act.
To Hong Kong Residents:
This publication is distributed in Hong Kong by RBC Capital Markets (Hong Kong) Limited and Royal Bank of Canada, Hong Kong Branch (both entities which are
regulated by the Hong Kong Monetary Authority ('HKMA') and the Securities and Futures Commission ('SFC')). Financial Services provided to Australia: Financial
services may be provided in Australia in accordance with applicable law. Financial services provided by the Royal Bank of Canada, Hong Kong Branch are provided
pursuant to the Royal Bank of Canada's Australian Financial Services Licence ('AFSL') (No. 246521). RBC Capital Markets (Hong Kong) Limited is exempt from the
requirement to hold an AFSL under the Corporations Act 2001 in respect of the provision of such financial services. RBC Capital Markets (Hong Kong) Limited is
regulated by the HKMA and the SFC under the laws of Hong Kong, which differ from Australian laws.
To Singapore Residents:
This publication is distributed in Singapore by the Royal Bank of Canada, Singapore Branch, a registered entity granted offshore bank licence by the Monetary
Authority of Singapore. This material has been prepared for general circulation and does not take into account the objectives, financial situation, or needs of any
recipient. You are advised to seek independent advice from a financial adviser before purchasing any product. If you do not obtain independent advice, you should
consider whether the product is suitable for you. Past performance is not indicative of future performance. If you have any questions related to this publication,
please contact the Royal Bank of Canada, Singapore Branch. Royal Bank of Canada, Singapore Branch accepts responsibility for this report and its dissemination
in Singapore.
To Japanese Residents:
Unless otherwise exempted by Japanese law, this publication is distributed in Japan by or through RBC Capital Markets (Japan) Ltd., a registered type one financial
instruments firm and/or Royal Bank of Canada, Tokyo Branch, a licensed foreign bank.
. Registered trademark of Royal Bank of Canada. RBC Capital Markets is a trademark of Royal Bank of Canada. Used under license.
Copyright RBC Capital Markets, LLC 2015 - Member SIPC
Copyright RBC Dominion Securities Inc. 2015 - Member CIPF
Copyright RBC Europe Limited 2015
Copyright Royal Bank of Canada 2015
All rights reserved
Michael J. Yee,
13