2. Introductions and Objective
Webinar Moderator: Stacy Mecham
Senior Vice President,
Oncology Franchise,
AlphaImpactRx
Objective
• To share our unique perspective on the dynamics of today’s oncology marketplace.
• To advance your understanding of the unprecedented changes emerging across
promotion, treatment and testing - and to provide a view into how 2016 is shaping
up.
2
Featured Presenter: Mark Purcell
Managing Director
and Head of Global
Pharmaceutical
Equity Research
Coverage, Barclays
3. Our Agenda
3
• A snapshot of the current Oncology Promotional Landscape
• The I/O Battlefield
NSCLC
Melanoma
PD-L1 Testing
• Preparing for ASH and San Antonio Breast Cancer Conferences
Breast Cancer
CLL
• Q&A
4. …and once earned, you need
to make the most of it.
The battle to earn the Oncologist’s
attention is becoming more challenging...
4
5. Novartis is emerging as the leader within a crowded oncology
promotional landscape.
n=Total sales representative product details BrandImpact Oncology panel had ~ 450 physicians in October 2015
ShareofDetails
Source: BrandImpact
0%
2%
4%
6%
8%
10%
12%
14%
2010 2011 2012 2013 2014 2015 (Jan-Oct)
Novartis GSK Genentech BMS Merck Celgene
Pfizer Boehringer Ing. Lilly Bayer Janssen Amgen
Eisai Pharmacyclics Medivation Millennium Sanofi Teva
Onyx Incyte AstraZeneca
n=35,979 n=33,970 n=34,408 n=31,103 n=30,028 n=28,498
Share of Attention – Company Level Detailing - Oncology (2010-2015)
March ‘15: Novartis
acquires Oncology
franchise from GSK
5
6. Is access to the Oncologist opening up?
6
After a decline through the end of
2013, the surge in new launches
and new indications starting 2014
may have required an increase in
time allocated to seeing reps…
…and, the average time allocated to each
detail has also increased.
20
40
60
80
100
120
140
160
180
Q1
2012
Q2
2012
Q3
2012
Q4
2012
Q1
2013
Q2
2013
Q3
2013
Q4
2013
Q1
2014
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
5
6
7
8
9
10
Source: BrandImpact
Average Minutes Allotted to Detailing per Quarter (Oncologists)
Source: BrandImpact
7. Source: BrandImpact
7
2,894
1,842
1,305
1,034 942 893
643 574 572
414
0
400
800
1,200
1,600
2,000
2,400
2,800
3,200
Lung Cancer Breast Cancer CLL Colorectal
Cancer
Multiple
Myeloma
Renal Cell CML Mantle Cell
Lymphoma
Melanoma Gastric Cancer
Details by Indication (YTD October 2015)
Indication-level details reported most often
reflect the influx of new brands, the number
of players in certain tumor markets, and the
competitive nature of these market segments.
n=number of details reported by indication for the time period
NSCLC is the most frequently-
detailed tumor type so far in
2015, overtaking breast cancer.
Indication 2015 Rank
(YTD Oct)
2014 2013
NSCLC 1 2 3
Breast Cancer 2 1 1
CLL 3 4 11
Colorectal Cancer 4 5 2
Multiple Myeloma 5 3 4
Renal Cell 6 9 7
CML 7 7 5
Mantle Cell Lymphoma 8 11 13
Melanoma 9 8 8
Gastric Cancer 10 35 36
Understanding detailing at the indication level is critical.
8. Source: BrandImpact
8
Measuring details at the brand level is no longer enough.
Top 10 Detailed
Brands
2015 Rank
(YTD Oct)
Opdivo 1
Afinitor 2
Imbruvica 3
Keytruda 4
Avastin 5
Cyramza 6
Ibrance 7
Revlimid 8
Xtandi 9
Neulasta 10
Top 10 Detailed
Brands by Ind
Indication 2015 Rank
(YTD Oct)
Opdivo NSCLC 1
Afinitor Breast Cancer 3
Ibrance Breast Cancer 3
Imbruvica CLL 4
Keytruda Melanoma 5
Xtandi Prostate Cancer 6
Neulasta Neutropenia 7
Gazyva CLL 8
Cyramza NSCLC 9
Kyprolis Multiple Myeloma 10
9. Barclays Capital Inc. and/or one of its affiliates does and seeks to do business with companies covered in its research reports. As a result, investors should be
aware that the firm may have a conflict of interest that could affect the objectivity of this report.
Investors should consider this report as only a single factor in making their investment decision.
This research report has been prepared in whole or in part by equity research analysts based outside the US who are not registered/qualified as research analysts
with FINRA.
PLEASE SEE ANALYST CERTIFICATIONS AND IMPORTANT DISCLOSURES BEGINNING ON PAGE 52.
Equity Research
Barclays Global Pharmaceuticals
Mark Purcell
Barclays, UK
+44 203 1347189
mark.purcell@barclays.com
Thinking ahead in oncology
An analyst’s perspective
1 December 2015
10. • Introduction
• Lung cancer – Opdivo versus the competition
• Key questions / perspectives in an increasingly crowded indication; 1L data in 2016
• Melanoma battleground
• Opdivo vs Keytruda; Immunotherapy versus targeted treatments; emerging combos
• Breast cancer
• Ibrance launch perspectives in HER2-ve patients
• Perjeta perspectives –a race against time
• Chronic Lymphocytic Leukemia
• Where next for Imbruvica?
Thinking ahead in oncology
Overview
December 1, 201510
Source: Barclays Research
12. The role of a stock market analyst
An overview of my role and what I do
Source: Barclays Research
December 1, 201512
Financial
analysis
Therapeutic
analysis
Industry analysisReports/presentations
Breadth of analysis… …requires a team approach
Stock recommendations
Investment ideas
US pharma
US biotech
US medtech
etc
Japan pharma
India pharma
etc
Global
research
US biopharma Asia biopharma
Distribution
EU pharma
EU generics
EU medtech
etc
EU biopharma
GibsonPurcell Capra Ak’sola KlebanLeuchten
13. December 1, 201513
Therapeutic market analysis
• Prescription data
• IMS Smart Solutions (US), MIDAS (global), NPA (US)
• AlphaImpactRx (US)
• Customer perspectives
• KOL calls/surveys; conference feedback
• PBM/managed care (US); NICE/IQWIG assessment (EU)
• Company reports and meetings
• Quarterly earnings releases and conference calls
• Analyst meetings; company field trips
Market data
Physician /
payor feedback
Company
perspective
Which data sources do we use?
Source: Barclays Research
15. December 1, 201515
Common questions with immunoncology
• PD-(L)-1 treatment benefits 25-65% of refractory non-
squamous NSCLC relative to standard chemotherapy
• Will patient triaging based on an imperfect diagnostic enrichment
approach take off? Who has the best approach?
• Will chemotherapy be squeezed or be used in combo?
• Payors have targeted therapeutic areas such as respiratory
and diabetes – how about oncology?
• Will payors start using exclusions in oncology eg CML?
• Will payors restrict use based on diagnostic enrichment?
• Oncology is clearly a crowded pipeline area
• Speed of uptake for immunoncology approaches?
• Are refractory patient shares representative of potential front line
patient shares?
• Will third/fourth to market use price to gain market share?
• How will costs be divided in combination approaches?
Patient triaging
Payor influence
Competition
Will patients be triaged? Can payors influence prescribing? Will competition act rationally?
Source: Barclays Research
16. Comparative Testing Rates for PD-L1 and Established
Biomarkers in mNSCLC and mM
Source: Barclays Research; BrandImpact / BrandImpactDx
;
December 1, 201516
17. December 1, 201517
PD-L1 Testing Rates for mNSCLC and mM Among PD-L1
Testers and Percent of Their Patients Tested
Source: Barclays Research , BrandImpact/BrandImpactDx
PD-L1 testing is more common in NSCLC patients (48% oncologists) versus melanoma (25%)
19. December 1, 201519
Key questions / perspectives in lung cancer
• Pivotal data H2 2016; 60% of patients; diverse strategies
• BMY and MRK PD-L1+ve mono initially; chemo combo
studies now started
• ROG main focus chemo combos; AZN treme / EGFRi /
chemo combos
• PD-L1 biomarker debate in non-squamous (76% of patients)
• PD-L1 enrichment suggests relative benefit for 68% (ROG),
36% (BMY), 23% (MRK) non-squamous patients vs chemo
• BMY all comers approach – lack of reimbursement concerns
• Treat all-comers (better tolerability than chemo) or
diagnostically enrich for PD-L1 responders?
• Are all diagnostic approaches equal (ROG IC/TC approach)
• Duration of therapy an issue – median number doses just 6?
• Q3W preferred versus Q2W dosing? % of patients
contraindicated with autoimmune conditions?
Front-line
NSCLC
Refractory
NSCLC
Triaging/
duration
Most intense and potentially crowded battleground for i/o therapies
Source: Barclays Research
20. NSCLC Market Shares Based on PD-L1 Status (squamous)
December 1, 201520
Opdivo treated patients – 46% untested, 33% PD-L1 –ve, 20% PD-L1 +ve
Keytruda – approved for PD-L1 +ve patients only
Only 20% of PD-L1 testing occurs in the 2L+ setting
PD-L1 Positive: R6M May-Oct 2015
n=217
dr=28
PD-L1 Negative/Other: R6M May-Oct 2015
n=517
dr=70
Untested Patients: R6M May-Oct 2015
n=757
dr=99
PD-L1 Tested Patients Untested Patients
Keytruda,
1%
Tarceva,
1%
Cyramza,
1%
Opdivo,
49%
Abraxane,
10%
Other
Chemo,
35%
Untreated,
4%
Tarceva,
1% Cyramza,
2%
Opdivo,
32%
Abraxane,
13%
Other
Chemo,
39%
Untreated,
11%
Tarceva,
2% Cyramza,
1%
Opdivo,
34%
Abraxane,
15%
Other
Chemo,
39%
Untreated,
9%
Overall mNSCLC Shares (R6M Through October 2015)
Source: Barclays Research , AlphaImpactRx
Report Definition: (n = number of Patient Visits diagnosed and receiving systemic therapy; dr = number of physicians
reporting,
based on a sample of 170 oncologists, of whom 81(43%) have tested for PD-L1 in some patients).
“Other Chemo’ includes Gemzar, Navelbine, Taxol, and Taxotere. Results may vary from 100% due to rounding.
“PD-L1 Negative/Other” includes patients where the results are negative, pending or inconclusive.
Overall shares include all patients, treated and untreated, and excludes patients on maintenance therapy.
21. Anti-PD-1 US revenue progression – NSCLC inflection?
December 1, 201521
NCCN support and FDA approval in squamous and then non-squamous NSCLC has
driven an acceleration in anti-PD-1 revenues in the US
Source: Barclays Research
NCCN
supports 1L
melanoma
Opdivo FDA
approval sq
NSCLC
0
20
40
60
80
100
120
140
160
$m
Keytruda Opdivo Total
FDA approval
Keytruda
NSCLC 2 Oct;
Opdivo non-sq
NSCLC 9 Oct
$m Q3'14 Q4'14 Q1'15 Q2'15 Q3'15
Keytruda IMS estimated 7 47 72 89 109
Keytruda reported 44 66 86 109
Opdivo IMS estimated - 0 19 112 239
Opdivo reported 1 38 107 268
Opdivo non-sq
NSCLC data
at ASCO
22. December 1, 201522
What next?
• How strong will the OS benefit be in KN-010 trial? (920pts, PD-
L1+ve vs Taxotere; Opdivo has set all-comer OS benchmark:
HR of 0.62 in sq and 0.73 in non-sq 2L+NSCLC vs Taxotere)
• Will Keytruda launch first in PD-L1+ve 1L NSCLC and be
reimbursed for all vs just PS>50% pts (KN-024 June’16)?
• Can Roche file atezo with FDA based on BIRCH/FIR data?
• How strong will the OS benefit be in the OAK trial mid’16
(1225pts, all comers vs Taxotere; Opdivo the benchmark)
• Front-line data from Impower trials 2017
• Can AZN file durva based on 3L+ PD-L1+ ATLANTIC trial?
Keytruda
(Merck)
atezolizumab
(Roche)
durvalumab
(AstraZeneca)
Data pending for refractory NSCLC ahead of front-line data H2’16
Source: Barclays Research
• Front-line data in PDL-1+ve (PS>1%) from Checkmate-024
trial expected August’16
Opdivo
(BMY)
23. December 1, 201523
Overall mNSCLC Market Shares (Non-Squamous Histology)
Opdivo penetration has expanded to 13% in non-squamous NSCLC following FDA
approval 9 October, taking share from chemotherapy and capturing untreated patients;
targeted therapies for patients expressing EGFR / ALK mutations broadly stable
Source: Barclays Research, AlphaImpactRx
24. December 1, 201524
1st Line mNSCLC Market Shares (Non-Squamous)
Alimta-containing regimens have the largest share in 1st line therapy. Opdivo currently
has 2% penetration off-label in this segment
Source: Barclays Research, AlphaImpactRx
25. December 1, 201525
2nd Line+ mNSCLC Market Shares (Non-Squamous)
Opdivo catapulted to first place in refractory non-squamous patients, largely at the
expense of cytotoxic agents. Keytruda 4% share in first month post-approval.
Source: Barclays Research, AlphaImpactRx
26. December 1, 201526
Overall mNSCLC Market Shares (Squamous Cell Histology)
Opdivo has surpassed chemotherapy regimens to become the leading treatment for
patients with squamous cell NSCLC
Source: Barclays Research, AlphaImpactRx
27. December 1, 201527
1st Line mNSCLC Market Shares (Squamous Cell Histology)
Cytotoxic chemotherapy remains the standard approach in 1st line therapy. Abraxane is
currently used in over a quarter of patients. Opdivo has a modest presence to date .
Source: Barclays Research, AlphaImpactRx
28. December 1, 201528
2nd Line+ mNSCLC Market Shares (Squamous Cell Histology)
Opdivo has quickly become the preferred treatment option in 2nd line+ squamous NSCLC
with a 75% market penetration, taking share from chemotherapy and Abraxane.
Keytruda 7% share in first month post-approval
Source: Barclays Research, AlphaImpactRx
30. December 1, 201530
Key questions / perspectives in melanoma
• Opdivo monotherapy PDUFA 27 Nov; Keytruda monotherapy
PDUFA 19 Dec
• Opdivo and Keytruda both beat Yervoy monotherapy in CM-
066 and KN-066, respectively
• Opdivo+Yervoy superior to Opdivo alone based on PFS but
with a tolerability penalty (30% discontinuation due to AEs)
• Keytruda launched first and has maintained leading share
• Opdivo/Keytruda monotherapy data look comparable
• Is Q3W dosing an advantage for Keytruda?
• In CM-067, one third PD-L1>5% and two thirds PD-L1<5%.
Opdivo comparable mPFS to Opdivo+Yervoy (14.0m) in pts
PD-L1>5% patients – if replicated in OS data, will combo be
reserved for PD-L1<5%
• BRAF+MEKi trial COMBI-d shows 25.1m median OS in V600E
mutation positive patients – with a lower 13% discontinuation
rate, can BRAF+MEKi hold onto (PD-L1-ve) market share?
Front-line
melanoma
Refractory
melanoma
Triaging
Straight Opdivo versus Keytruda battle; how much share will BRAF/MEKi combos retain?
Source: Barclays Research
31. Melanoma Market Shares Based on PD-L1 Status
December 1, 201531
Opdivo treated patients – 50% untested, 27% PD-L1 –ve, 23% PD-L1 +ve
Keytruda treated patients – 52% untested, 26% PD-L1 –ve, 23% PD-L1 +ve
Source: Barclays Research , AlphaImpactRx AlphaImpact
32. December 1, 201532
What next?
• 1L PDUFA 19 Dec; Yervoy-refractory PDUFA 24 Dec
• Phase 3 “go decision” taken on Keytruda + Incyte’s IDO
inhibitor epacadostat based on 53% ORR in 19 patients (c.79%
PD-L1+ve)
• 1L monotherapy PDUFA 27 Nov based on CM-066 trial
• 76% ORR and 20.9m DOR in combination with Zelboraf in 1L
BRAFV600 mutant patients; awaiting data from phase 1b trial of
atezo+Zelboraf+Cotellic data before assessing next steps
Keytruda
(Merck)
atezolizumab
(Roche)
Following additional monotherapy approvals, focus shifts to future combinations
Source: Barclays Research
Opdivo
(BMY)
33. December 1, 201533
Overall Metastatic Melanoma Shares
Keytruda has surpassed Yervoy as the leader metastatic melanoma treatment, but is facing
increasing competition from Mekinist/Tafinlar, Opdivo and the Opdivo/Yervoy combination
Source: Barclays Research, AlphaImpactRx
34. December 1, 201534
1st Line Metastatic Melanoma Shares
Keytruda and Mekinist/Tafinlar were essentially tied for the lead position in the frontline
setting. Use of single agent Opdivo has declined and Yervoy monotherapy shares have
plummeted, in part because these two brands are increasingly being used in combination
Source: Barclays Research, AlphaImpactRx
35. December 1, 201535
2nd Line+ Metastatic Melanoma Shares
Keytruda remained the most frequently prescribed treatment in this segment, albeit with a
drop in share to 35% as Opdivo and the Opdivo/Yervoy combination gained share
Source: Barclays Research, AlphaImpactRx
36. December 1, 201536
1st Line Metastatic Melanoma Shares (BRAF Mutation+)
Led by the Mekinist/Tafinlar combination, BRAF-mutation targeted agents have
continued to make share gains supported by the COMBI-d and coBRIM pivotal data
(25.1 month and 22.3 month median overall survival, respectively)
Source: Barclays Research, AlphaImpactRx
37. December 1, 201537
2nd Line+ Metastatic Melanoma Shares (BRAF Mutation+)
The Mekinist/Tafinlar combination and Keytruda were tied for the top spot among
patients expressing BRAF V600 mutations who have received prior therapy
Source: Barclays Research, AlphaImpactRx
39. December 1, 201539
Key perspectives for Ibrance in HER2-ve breast cancer
• Ibrance Q3 2015 US revenues $229m following first-line
accelerated approval – where next?
• Positive 2L+ PALOMA-3 data (ASCO) and PALOMA-2 data
(Q4’15E) should further support the launch
• Using Afinitor as a proxy: 55% sales in breast cancer =>
c.$120m US sales per quarter from 11% share. Implied
Ibrance quarterly sales circa $270m (circa $229m currently)
• PENELOPE-B trial in neo-adjuvant breast cancer data 2020
• Trials outside breast cancer – eg lung cancer
• Afinitor generics 2019 onwards could drive pricing pressure
• LLY abemaciclib – MONARCH 2 data in breast cancer H1’17,
JUNIPER 2L+ lung data H2’16; monotherapy activity,
continuous dosing, brain penetration advantages?
• NOVN ribociclib (LEE011) – MONALEESA-2 and -7 data in
breast cancer H2’17 / H1’18
Ibrance in
context
Opportunities
Threats
Off to a strong start, but what is the revenue and competitive outlook?
Source: Barclays Research
40. December 1, 201540
Overall HR+/HER2- mBC Shares (Post-Menopausal)
Ibrance has assumed the second position in the overall ER+/HER2- mBC market ,
having overtaken AI monotherapy, Faslodex and Afinitor
Source: Barclays Research, AlphaImpactRx
41. December 1, 201541
1st Line HR+/HER2- mBC Shares (Post-Menopausal)
Ibrance is closing in on AI monotherapy for the lead in the 1st line setting, with a share of
nearly 30% in October
Source: Barclays Research, AlphaImpactRx
42. December 1, 201542
1st Line HR+/HER2- mBC Shares - New Starts (Post-Menopausal)
Ibrance also leads in the share of new prescriptions for 1st line therapy, having captured
37% of NWRXs in October.
Source: Barclays Research, AlphaImpactRx
43. December 1, 201543
2nd / 3rd Line HR+/HER2- mBC Shares (Post-Menopausal)
Ibrance use has also steadily increased in the 2nd line setting, where it is now in the third
position, ahead of Afinitor. Pre-treated patients on 3rd line therapy or greater tend to
receive cytotoxic therapy
Source: Barclays Research, AlphaImpactRx Source: Barclays Research, AlphaImpactRx
• 2nd Line HR+/ HER2- Post-Menopausal mBC Patients
(Through October 2015)
• 3rd Line+ HR+/ HER2- Post-Menopausal mBC Patients
(Through October 2015)
45. December 1, 201545
Protecting Roche’s breast cancer franchise – Perjeta update
• Perjeta and Kadcyla have accelerated revenue growth of
Roche’s HER2 franchise to 19% - however Herceptin remains
68% US / 78% ex-US franchise by value:
• Perjeta penetration >50% on-label (>70% neo-adjuvant)
• Subcutaneous Herceptin >30% conversion
• Kadcyla+Perjeta 1L trial MARIANNE failed
• Perjeta driving Herceptin duration of use
• Perjeta 2L+ PHEREXA trial 2015/16
• Perjeta APHINITY trial H1 2016 (55% of Herceptin use)
• The race against time – Herceptin biosimilars!
• Herceptin COMP 2014 EU (2ndry patents?), 2019 US
• Samsung bioepsis (Jan’16; NA); Amgen ABP-980 (Mar’16;
NA); Celltrion (Dec’16; NA), Pfizer (Oct’16; 1L / Dec’16 NA)
Perjeta in
context
Opportunities
Threats
Off to a strong start, but what is the revenue and competitive outlook?
Source: Barclays Research
46. December 1, 201546
Neoadjuvant / Adjuvant HER2+ Breast Cancer Shares
• The Perjeta/Herceptin combination now dominates the neoadjuvant HER2+ space
• In the adjuvant setting Herceptin remains the most widely used option- APHINITY
data are needed to tap this key (55% Herceptin revenues) opportunity
Source: Barclays Research, AlphaImpactRx
47. December 1, 201547
1st Line HER2+/HR- mBC Shares
The Perjeta/Herceptin combination has become the dominant regimen in frontline
treatment of HER2+/HR- mBC; the MARIANNE data precludes Keytruda moving into this
setting; other Herceptin-based regimens gained share in October
Source: Barclays Research, AlphaImpactRx
48. December 1, 201548
1st Line HER2+/HR+ mBC Shares
The Perjeta/Herceptin combination has a commanding 60% share in 1st line treatment
among HER2+ mBC patients who are also HR+
Source: Barclays Research, AlphaImpactRx
49. December 1, 201549
2nd Line+ HER2+/HR- mBC Shares
Kadcyla is being used in a majority of the patients on 2nd line+ therapy for HER2+/HR-
mBC on the back of the EMILIA trial; Perjeta 2L+ PHEREXA trial reports 2015/16 and
could boost penetration
Source: Barclays Research, AlphaImpactRx
50. December 1, 201550
2nd Line+ HER2+/HR+ mBC Shares
Other treatment options come into play in 2nd line+ therapy for patients who are
HER2+/HR+. Herceptin is still widely used, particularly in combination with HT or Perjeta
Source: Barclays Research, AlphaImpactRx
52. December 1, 201552
Imbruvica label expansion in focus post ABBV+PCYC deal
• ABBV acquired PCYC for Imbruvica =>1bn revenues in 2015E,
>$7bn peak sales guidance (implied >$10bn globally) ahead of
LOE end 2026:
• Rapid penetration in refractory CLL and p17 del 1L CLL
• Competition from GILD’s Zydelig
• Expanded indications: 1L CLL (RESONATE-2; H2’15;
ECOG1912 H1’17; 1L CLL >35% larger in terms of patient
numbers than 2L/3L); non-GCB NHL (PHOENIX; mid’18); 1L
MCL (SHINE; mid’18); FL (DAWN H2’15, SELENE HE’17)
• Duration of use - >>14 months in 1L CLL? 94% 2yr DFS!!
• Combination trials with ABBV assets ABT-199 (bcl-2 inhibitor)
and duvelisib (PI3K δ,γ inhibitor like Zydelig)
• GILD – in-licensed BTK inhibitor ONO-4059 end 2014
• BTK inhibitors with improved selectivity – Acerta Pharma,
Beigene, Eternity Biosciences etc
Imbruvica in
context
Opportunities
Threats
Imbruvica standard of care in refractory CLL – so where next?
Source: Barclays Research
53. December 1, 201553
CLL Patients by 17p Deletion Status
Most patients with CLL are being tested and 20% express the 17p deletion [higher than
the 5-10% expected, possibly as the CLL panel represents patients treated with systemic
therapy (as opposed to “watchful waiting”)]
Source: Barclays Research, AlphaImpactRx
54. December 1, 201554
Overall CLL Market Shares
Imbruvica has become the leading therapeutic option within the overall CLL space,
followed in turn by Treanda and Rituxan
Source: Barclays Research, AlphaImpactRx
55. December 1, 201555
CLL Market Shares (1st Line)
Treanda-based treatment held onto the lead position in October, but Imbruvica penetration
continues to rise at the expense of Rituxan-based treatments ahead of RESONATE-2
Source: Barclays Research, AlphaImpactRx
56. December 1, 201556
CLL Market Shares (2nd Line and 3rd line)
Imbruvica has far and away become the leading therapeutic option for previously treated
patients with CLL and far surpasses the performance of Zydelig in these settings
Source: Barclays Research, AlphaImpactRx Source: Barclays Research, AlphaImpactRx
57. December 1, 201557
CLL Market Shares (17p del+ / 1st Line)
Imbruvica has come to dominate treatment among patients who express the 17p deletion
Source: Barclays Research, AlphaImpactRx
58. December 1, 201558
CLL Market Shares 17p del+ (1st Line)
Imbruvica continues to own the 1st line therapy space for 17p del+ CLL and is now being
used in nearly 3 out of 4 patients
Source: Barclays Research, AlphaImpactRx
59. December 1, 201559
CLL Market Shares in 17p del+ Patients (2nd Line and 3rd Line+)
Imbruvica is likewise the market leader among previously treated patients who are 17d
del+, particularly in the 2nd line setting. Other treatment options saw a spike in October
Source: Barclays Research, AlphaImpactRx Source: Barclays Research, AlphaImpactRx
60. December 1, 201560
Analyst Certifications and Important Disclosures
Analyst(s) Certification(s):
I, Mark Purcell, hereby certify (1) that the views expressed in this research report accurately reflect my personal views about any or all of the subject securities or
issuers referred to in this research report and (2) no part of my compensation was, is or will be directly or indirectly related to the specific recommendations or
views expressed in this research report.
Important Disclosures:
Barclays Capital Inc. and/or one of its affiliates does and seeks to do business with companies covered in its research reports. As a result, investors should be
aware that the firm may have a conflict of interest that could affect the objectivity of this report.
Investors should consider this report as only a single factor in making their investment decision.
The analysts responsible for preparing this research report have received compensation based upon various factors including the firm's total revenues, a portion
of which is generated by investment banking activities.
This research report has been prepared in whole or in part by equity research analysts based outside the US who are not registered/qualified as research
analysts with FINRA.
Research analysts employed outside the US by affiliates of Barclays Capital Inc. are not registered/qualified as research analysts with FINRA. These analysts
may not be associated persons of the member firm and therefore may not be subject to NASD Rule 2711 and incorporated NYSE Rule 472 restrictions on
communications with a subject company, public appearances and trading securities held by a research analyst’s account.
Analysts regularly conduct site visits to view the material operations of covered companies, but Barclays policy prohibits them from accepting payment or
reimbursement by any covered company of their travel expenses for such visits.
Barclays Research is a part of the Investment Bank of Barclays Bank PLC and its affiliates (collectively and each individually, "Barclays"). Where any companies
are the subject of this research report, for current important disclosures regarding those companies please send a written request to: Barclays Compliance
Department, 745 Seventh Avenue, 13th Floor, New York, NY 10019 or refer to http://publicresearch.barclays.com or call 212-526-1072.
In order to access Barclays Statement regarding Research Dissemination Policies and Procedures, please refer to
https://live.barcap.com/publiccp/RSR/nyfipubs/disclaimer/disclaimer-research-dissemination.html. In order to access Barclays Research Conflict Management
Policy Statement, please refer to: https://live.barcap.com/publiccp/RSR/nyfipubs/disclaimer/disclaimer-conflict-management.html.
The Investment Bank's Research Department produces various types of research including, but not limited to, fundamental analysis, equity-linked analysis,
quantitative analysis, and trade ideas. Recommendations contained in one type of research product may differ from recommendations contained in other types of
research, whether as a result of differing time horizons, methodologies, or otherwise.
61. December 1, 201561
Important Disclosures (continued)
Risk Disclosure(s)
Master limited partnerships (MLPs) are pass-through entities structured as publicly listed partnerships. For tax purposes, distributions to MLP unit holders may
be treated as a return of principal. Investors should consult their own tax advisors before investing in MLP units.
Mentioned Stocks (Ticker, Date, Price)
AbbVie Inc. (ABBV, 25-Nov-2015, USD 60.29), Overweight/Neutral, A/C/D/J/K/L/M/O
AstraZeneca (AZN.L, 26-Nov-2015, GBP 45.20), Underweight/Neutral, C/D/J/K/L/M/N
Bristol-Myers Squibb (BMY, 25-Nov-2015, USD 68.08), Equal Weight/Neutral, A/C/D/J/K/L/M/N
Johnson & Johnson (JNJ, 25-Nov-2015, USD 101.96), Equal Weight/Neutral, C/J/K/M/N
Merck & Co. (MRK, 25-Nov-2015, USD 53.72), Equal Weight/Neutral, C/D/J/K/L/M/N/O
Merck KGaA (MRCG.DE, 26-Nov-2015, EUR 96.46), Equal Weight/Neutral, A/D/E/J/K/L/M/N
Pfizer Inc. (PFE, 25-Nov-2015, USD 32.87), Equal Weight/Neutral, C/D/J/K/L/M/O
Roche (ROG.VX, 26-Nov-2015, CHF 274.00), Overweight/Neutral, A/D/E/J/K/L/M/N
Other Material Conflicts: Barclays Bank and or its affiliate is advising GeneWEAVE BioSciences Inc in relation to their potential acquisition by Roche (SIX:ROG.)
The ratings, price targets and estimates on Roche (SIX:ROG) do not incorporate this transaction.
62. December 1, 201562
Important Disclosures (continued)
Disclosure Legend:
A: Barclays Bank PLC and/or an affiliate has been lead manager or co-lead manager of a publicly disclosed offer of securities of the issuer in the previous 12
months.
B: An employee of Barclays Bank PLC and/or an affiliate is a director of this issuer.
C: Barclays Bank PLC and/or an affiliate is a market-maker in equity securities issued by this issuer.
D: Barclays Bank PLC and/or an affiliate has received compensation for investment banking services from this issuer in the past 12 months.
E: Barclays Bank PLC and/or an affiliate expects to receive or intends to seek compensation for investment banking services from this issuer within the next 3
months.
F: Barclays Bank PLC and/or an affiliate beneficially owned 1% or more of a class of equity securities of the issuer as of the end of the month prior to the
research report's issuance.
G: One of the analysts on the coverage team (or a member of his or her household) owns shares of the common stock of this issuer.
H: This issuer beneficially owns 5% or more of any class of common equity securities of Barclays PLC.
I: Barclays Bank PLC and/or an affiliate has a significant financial interest in the securities of this issuer.
J: Barclays Bank PLC and/or an affiliate is a liquidity provider and/or trades regularly in the securities of this issuer and/or in any related derivatives.
K: Barclays Bank PLC and/or an affiliate has received non-investment banking related compensation (including compensation for brokerage services, if
applicable) from this issuer within the past 12 months.
L: This issuer is, or during the past 12 months has been, an investment banking client of Barclays Bank PLC and/or an affiliate.
M: This issuer is, or during the past 12 months has been, a non-investment banking client (securities related services) of Barclays Bank PLC and/or an affiliate.
N: This issuer is, or during the past 12 months has been, a non-investment banking client (non-securities related services) of Barclays Bank PLC and/or an
affiliate.
O: Barclays Capital Inc., through Barclays Market Makers, is a Designated Market Maker in this issuer's stock, which is listed on the New York Stock Exchange.
At any given time, its associated Designated Market Maker may have "long" or "short" inventory position in the stock; and its associated Designated Market
Maker may be on the opposite side of orders executed on the floor of the New York Stock Exchange in the stock.
P: A partner, director or officer of Barclays Capital Canada Inc. has, during the preceding 12 months, provided services to the subject company for remuneration,
other than normal course investment advisory or trade execution services.
Q: Barclays Bank PLC and/or an affiliate is a Corporate Broker to this issuer.
R: Barclays Capital Canada Inc. and/or an affiliate has received compensation for investment banking services from this issuer in the past 12 months.
S: Barclays Capital Canada Inc. is a market-maker in an equity or equity related security issued by this issuer.
T: Barclays Bank PLC and/or an affiliate is providing equity advisory services to this issuer.
U: The equity securities of this Canadian issuer include subordinate voting restricted shares.
V: The equity securities of this Canadian issuer include non-voting restricted shares.
W: Barclays Bank PLC and/or an affiliate should be assumed to be an actual beneficial owner of 1% or more of all the securities (including debt securities) of this
issuer as of the end of the month prior to the research report's issuance.
63. December 1, 201563
Important Disclosures (continued)
Guide to the Barclays Fundamental Equity Research Rating System:
Our coverage analysts use a relative rating system in which they rate stocks as Overweight, Equal Weight or Underweight (see definitions below) relative to
other companies covered by the analyst or a team of analysts that are deemed to be in the same industry (“the industry coverage universe”). To see a list of
companies that comprise a particular industry coverage universe, please go to http://publicresearch.barclays.com.
In addition to the stock rating, we provide industry views which rate the outlook for the industry coverage universe as Positive, Neutral or Negative (see
definitions below). A rating system using terms such as buy, hold and sell is not the equivalent of our rating system. Investors should carefully read the entire
research report including the definitions of all ratings and not infer its contents from ratings alone.
Stock Rating
Overweight - The stock is expected to outperform the unweighted expected total return of the industry coverage universe over a 12-month investment horizon.
Equal Weight - The stock is expected to perform in line with the unweighted expected total return of the industry coverage universe over a 12-month investment
horizon.
Underweight - The stock is expected to underperform the unweighted expected total return of the industry coverage universe over a 12-month investment
horizon.
Rating Suspended - The rating and target price have been suspended temporarily due to market events that made coverage impracticable or to comply with
applicable regulations and/or firm policies in certain circumstances including where the Investment Bank of Barclays Bank PLC is acting in an advisory capacity
in a merger or strategic transaction involving the company.
Industry View
Positive - industry coverage universe fundamentals/valuations are improving.
Neutral - industry coverage universe fundamentals/valuations are steady, neither improving nor deteriorating.
Negative - industry coverage universe fundamentals/valuations are deteriorating.
Distribution of Ratings:
Barclays Equity Research has 2787 companies under coverage.
42% have been assigned an Overweight rating which, for purposes of mandatory regulatory disclosures, is classified as a Buy rating; 51% of companies with this
rating are investment banking clients of the Firm.
40% have been assigned an Equal Weight rating which, for purposes of mandatory regulatory disclosures, is classified as a Hold rating; 43% of companies with
this rating are investment banking clients of the Firm.
15% have been assigned an Underweight rating which, for purposes of mandatory regulatory disclosures, is classified as a Sell rating; 39% of companies with
this rating are investment banking clients of the Firm.
Guide to the Barclays Research Price Target:
Each analyst has a single price target on the stocks that they cover. The price target represents that analyst's expectation of where the stock will trade in the next
12 months. Upside/downside scenarios, where provided, represent potential upside/potential downside to each analyst's price target over the same 12-month
period.
64. December 1, 201564
Important Disclosures (continued)
Top Picks:
Barclays Equity Research's "Top Picks" represent the single best alpha-generating investment idea within each industry (as defined by the relevant "industry
coverage universe"), taken from among the Overweight-rated stocks within that industry. Barclays Equity Research publishes global and regional "Top Picks"
reports every quarter and analysts may also publish intra-quarter changes to their Top Picks, as necessary. While analysts may highlight other Overweight-rated
stocks in their published research in addition to their Top Pick, there can only be one "Top Pick" for each industry. To view the current list of Top Picks, go to the
Top Picks page on Barclays Live (https://live.barcap.com/go/keyword/TopPicksGlobal).
To see a list of companies that comprise a particular industry coverage universe, please go to http://publicresearch.barclays.com.
Barclays legal entities involved in publishing research:
Barclays Bank PLC (Barclays, UK)
Barclays Capital Inc. (BCI, US)
Barclays Securities Japan Limited (BSJL, Japan)
Barclays Bank PLC, Tokyo branch (Barclays Bank, Japan)
Barclays Bank PLC, Hong Kong branch (Barclays Bank, Hong Kong)
Barclays Capital Canada Inc. (BCCI, Canada)
Absa Bank Limited (Absa, South Africa)
Barclays Bank Mexico, S.A. (BBMX, Mexico)
Barclays Capital Securities Taiwan Limited (BCSTW, Taiwan)
Barclays Capital Securities Limited (BCSL, South Korea)
Barclays Securities (India) Private Limited (BSIPL, India)
Barclays Bank PLC, India branch (Barclays Bank, India)
Barclays Bank PLC, Singapore branch (Barclays Bank, Singapore)
Barclays Bank PLC, Australia branch (Barclays Bank, Australia)
65. December 1, 201565
Disclaimer
Disclaimer:
This publication has been produced by the Investment Bank of Barclays Bank PLC and/or one or more of its affiliates (collectively and each individually,
"Barclays"). It has been distributed by one or more Barclays legal entities that are a part of the Investment Bank as provided below. It is provided to our clients for
information purposes only, and Barclays makes no express or implied warranties, and expressly disclaims all warranties of merchantability or fitness for a
particular purpose or use with respect to any data included in this publication. Barclays will not treat unauthorized recipients of this report as its clients and
accepts no liability for use by them of the contents which may not be suitable for their personal use. Prices shown are indicative and Barclays is not offering to
buy or sell or soliciting offers to buy or sell any financial instrument.
Without limiting any of the foregoing and to the extent permitted by law, in no event shall Barclays, nor any affiliate, nor any of their respective officers, directors,
partners, or employees have any liability for (a) any special, punitive, indirect, or consequential damages; or (b) any lost profits, lost revenue, loss of anticipated
savings or loss of opportunity or other financial loss, even if notified of the possibility of such damages, arising from any use of this publication or its contents.
Other than disclosures relating to Barclays, the information contained in this publication has been obtained from sources that Barclays Research believes to be
reliable, but Barclays does not represent or warrant that it is accurate or complete. Barclays is not responsible for, and makes no warranties whatsoever as to,
the content of any third-party web site accessed via a hyperlink in this publication and such information is not incorporated by reference.
The views in this publication are those of the author(s) and are subject to change, and Barclays has no obligation to update its opinions or the information in this
publication. If this publication contains recommendations, those recommendations reflect solely and exclusively those of the authoring analyst(s), and such
opinions were prepared independently of any other interests, including those of Barclays and/or its affiliates. This publication does not constitute personal
investment advice or take into account the individual financial circumstances or objectives of the clients who receive it. The securities discussed herein may not
be suitable for all investors. Barclays recommends that investors independently evaluate each issuer, security or instrument discussed herein and consult any
independent advisors they believe necessary. The value of and income from any investment may fluctuate from day to day as a result of changes in relevant
economic markets (including changes in market liquidity). The information herein is not intended to predict actual results, which may differ substantially from
those reflected. Past performance is not necessarily indicative of future results.
This document is being distributed (1) only by or with the approval of an authorised person (Barclays Bank PLC) or (2) to, and is directed at (a) persons in the
United Kingdom having professional experience in matters relating to investments and who fall within the definition of "investment professionals" in Article 19(5)
of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (b) high net worth companies, unincorporated associations
and partnerships and trustees of high value trusts as described in Article 49(2) of the Order; or (c) other persons to whom it may otherwise lawfully be
communicated (all such persons being ''Relevant Persons''). Any investment or investment activity to which this communication relates is only available to and
will only be engaged in with Relevant Persons. Any other persons who receive this communication should not rely on or act upon it. Barclays Bank PLC is
authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority and is a member of
the London Stock Exchange.
The Investment Bank of Barclays Bank PLC undertakes U.S. securities business in the name of its wholly owned subsidiary Barclays Capital Inc., a FINRA and
SIPC member. Barclays Capital Inc., a U.S. registered broker/dealer, is distributing this material in the United States and, in connection therewith accepts
responsibility for its contents. Any U.S. person wishing to effect a transaction in any security discussed herein should do so only by contacting a representative of
Barclays Capital Inc. in the U.S. at 745 Seventh Avenue, New York, New York 10019.
Non-U.S. persons should contact and execute transactions through a Barclays Bank PLC branch or affiliate in their home jurisdiction unless local regulations
permit otherwise.
66. December 1, 201566
Disclaimer (continued)
Barclays Bank PLC, Paris Branch (registered in France under Paris RCS number 381 066 281) is regulated by the Autorité des marchés financiers and the
Autorité de contrôle prudentiel. Registered office 34/36 Avenue de Friedland 75008 Paris.
This material is distributed in Canada by Barclays Capital Canada Inc., a registered investment dealer, a Dealer Member of IIROC (www.iiroc.ca), and a Member
of the Canadian Investor Protection Fund (CIPF).
Subject to the conditions of this publication as set out above, the Corporate & Investment Banking Division of Absa Bank Limited, an authorised financial
services provider (Registration No.: 1986/004794/06. Registered Credit Provider Reg No NCRCP7), is distributing this material in South Africa. Absa Bank
Limited is regulated by the South African Reserve Bank. This publication is not, nor is it intended to be, advice as defined and/or contemplated in the (South
African) Financial Advisory and Intermediary Services Act, 37 of 2002, or any other financial, investment, trading, tax, legal, accounting, retirement, actuarial or
other professional advice or service whatsoever. Any South African person or entity wishing to effect a transaction in any security discussed herein should do so
only by contacting a representative of the Corporate & Investment Banking Division of Absa Bank Limited in South Africa, 15 Alice Lane, Sandton,
Johannesburg, Gauteng 2196. Absa Bank Limited is a member of the Barclays group.
In Japan, foreign exchange research reports are prepared and distributed by Barclays Bank PLC Tokyo Branch. Other research reports are distributed to
institutional investors in Japan by Barclays Securities Japan Limited. Barclays Securities Japan Limited is a joint-stock company incorporated in Japan with
registered office of 6-10-1 Roppongi, Minato-ku, Tokyo 106-6131, Japan. It is a subsidiary of Barclays Bank PLC and a registered financial instruments firm
regulated by the Financial Services Agency of Japan. Registered Number: Kanto Zaimukyokucho (kinsho) No. 143.
Barclays Bank PLC, Hong Kong Branch is distributing this material in Hong Kong as an authorised institution regulated by the Hong Kong Monetary Authority.
Registered Office: 41/F, Cheung Kong Center, 2 Queen's Road Central, Hong Kong.
Information on securities/instruments that trade in Taiwan or written by a Taiwan-based research analyst is distributed by Barclays Capital Securities Taiwan
Limited to its clients. The material on securities/instruments not traded in Taiwan is not to be construed as 'recommendation' in Taiwan. Barclays Capital
Securities Taiwan Limited does not accept orders from clients to trade in such securities. This material may not be distributed to the public media or used by the
public media without prior written consent of Barclays.
This material is distributed in South Korea by Barclays Capital Securities Limited, Seoul Branch.
All Indian securities-related research and other equity research produced by the Investment Bank are distributed in India by Barclays Securities (India) Private
Limited (BSIPL). BSIPL is a company incorporated under the Companies Act, 1956 having CIN U67120MH2006PTC161063. BSIPL is registered and regulated
by the Securities and Exchange Board of India (SEBI) as a Research Analyst: INH000001519; Portfolio Manager INP000002585; Stock Broker/Trading and
Clearing Member: National Stock Exchange of India Limited (NSE) Capital Market INB231292732, NSE Futures & Options INF231292732, NSE Currency
derivatives INE231450334, Bombay Stock Exchange Limited (BSE) Capital Market INB011292738, BSE Futures & Options INF011292738; Merchant
Banker: INM000011195; Depository Participant (DP) with the National Securities & Depositories Limited (NSDL): DP ID: IN-DP-NSDL-299-2008;
Investment Adviser: INA000000391. The registered office of BSIPL is at 208, Ceejay House, Shivsagar Estate, Dr. A. Besant Road, Worli, Mumbai – 400 018,
India. Telephone No: +91 2267196000. Fax number: +91 22 67196100. Any other reports produced by the Investment Bank are distributed in India by Barclays
Bank PLC, India Branch, an associate of BSIPL in India that is registered with Reserve Bank of India (RBI) as a Banking Company under the provisions of The
Banking Regulation Act, 1949 (Regn No BOM43) and registered with SEBI as Merchant Banker (Regn No INM000002129) and also as Banker to the Issue
(Regn No INBI00000950). Barclays Investments and Loans (India) Limited, registered with RBI as Non Banking Financial Company (Regn No RBI CoR-07-
00258), and Barclays Wealth Trustees (India) Private Limited, registered with Registrar of Companies (CIN U93000MH2008PTC188438), are associates of
BSIPL in India that are not authorised to distribute any reports produced by the Investment Bank.
Barclays Bank PLC Frankfurt Branch distributes this material in Germany under the supervision of Bundesanstalt für Finanzdienstleistungsaufsicht (BaFin).
68. Our Agenda
68
• A snapshot of the current Oncology Promotional Landscape
• The I/O Battlefield
NSCLC
Melanoma
PD-L1 Testing
• Preparing for ASH and San Antonio Breast Cancer Conferences
Breast Cancer
CLL
• Q&A
