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Q1 2016 Conference Call
April 28, 2016p ,
Attendees
Bob Hugin, Executive Chairman
Mark Alles, Chief Executive Officer
Peter Kellogg Chief Financial OfficerPeter Kellogg, Chief Financial Officer
Jackie Fouse, President & Chief Operating Officer
Scott Smith, President, Global I&I
2
Q&A
Forward Looking Statements and Adjusted Financial Information
This presentation contains forward-looking statements, which are generally statements that are not historical facts. Forward-lookingstatements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similarexpressions Forward-looking statements are based on management’s current plans estimates assumptions and projections and speakexpressions. Forward-looking statements are based on management s current plans, estimates, assumptions and projections, and speakonly as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information orfuture events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which aredifficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report onForm 10-K and our other reports filed with the Securities and Exchange Commission.
In addition to unaudited financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted financialmeasures that we believe provide investors and management with supplemental information relating to operating performance and trendsthat facilitate comparisons between periods and with respect to projected information These adjusted measures are non GAAP andthat facilitate comparisons between periods and with respect to projected information. These adjusted measures are non-GAAP andshould be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typicallyexclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition ofunusual or non-recurring items. Other companies may define these measures in different ways. Further information relevant to theinterpretation of adjusted financial measures, and reconciliations of these adjusted financial measures to the most comparable GAAPmeasures, may be found on our website at www.Celgene.com in the “Investor Relations” section.
3
Mark Alles
Q1 2016: An Exceptional Start to the Year
– Net product sales 21% Y/Y growth; Adjusted diluted EPS 23% Y/Y growth
Maximizing the Potential of Our Commercial Portfolio Maximizing the Potential of Our Commercial Portfolio
– Growth driven by strong volume and market dynamics
Continuing to Generate Industry Leading GrowthContinuing to Generate Industry Leading Growth– 2016: Raising the lower ranges of net product sales and adjusted diluted EPS guidance – 2017: Targeting 18% Y/Y net product sales and 22% Y/Y adjusted diluted EPS growth; long-term
targets on-track
g y gg y g
– Entered two-year period with data expected from 18 Ph III trialsAd i l th i t d th li i I d i ibilit i t l d id t
Advancing Our Robust, Innovative PipelineAdvancing Our Robust, Innovative Pipeline
5
– Advancing novel therapies toward the clinic; Increased visibility into our early- and mid-stage programs
Peter Kellogg
Strong Q1 Operating Results
Q1:16 year-over-year product sales grew 21% and adjusted diluted EPS grew 23% Adjusted operating margins improved by 160 bps
Financial HighlightsFinancial Highlights
Strong product growth across all franchisesInvestments in R&D while achieving meaningful SG&A leverage
Excellent Performance on Operating MetricsExcellent Performance on Operating Metrics
$1 4B in shares repurchased in Q1:16
Adding Value with Financial DriversAdding Value with Financial Drivers
Investments in R&D while achieving meaningful SG&A leverage
$1.4B in shares repurchased in Q1:16 Strong financial flexibility
2016 Guidance and Long-term Targets Updated2016 Guidance and Long-term Targets Updated
7
2016 adjusted diluted EPS -- bottom-end of the range raised from $5.50-$5.70 to $5.60-$5.70 2017 targets updated; 2020 targets on-track
Total Net Product Sales(Growth Rates = Growth vs. Prior Year Period)
$2,495
$1,708
$2,055
$2,495
illio
ns$
M
↑19% ↑20% ↑21%↑19% ↑20% ↑21%
Q1:14 Q1:15 Q1:16
8
Volume Drove Q1 2016 Net Product Sales Growth
Contribution to Q1:16 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
$2 000
$2,500↑21.4%↓1.5%↑19.2% ↑3.7%
$
$1,500
$2,000
Mill
ions
$500
$1,000
$0Q1:15 Volume Price Fx / Hedge Q1:16
9
Adjusted Diluted Earnings Per Share(Growth Rate = Growth vs. Prior Year Period)
$1.32
$0.83
$1.07
Shar
e
↑22% ↑29%Dol
lars
Per
S
↑23%↑ % ↑ %D ↑ %
Q1:14 Q1:15 Q1:16
10
Footnote: Adjusted EPS is split-adjusted for Q1:14
Key P&L Line Items (Adjusted)
Q1:16 ∆ vs.Q1:15
∆ vs.Q4:15
Product Gross Margin 96.1% ↑80 bps ↓10 bps
R&D expenses% of revenue
$591M23.5% ↑280 bps ↓180 bps
SG&A expenses% of revenue
$468M18.6% ↓370 bps ↓220 bps
Operating Margin 54.0% ↑160 bps ↑390 bps
Effective Tax Rate 16.6% ↑90 bps ↑170 bps
11
Q1 2016 Adjusted Diluted EPS Growth Driven by Increased Operating Income
$1.32$0.27$1.07 ($0.01) $0.04
Contribution to Q1:16 Adjusted Diluted EPS
($0.05)
ear
s Pe
r Sha
reD
olla
Q1:15 Operating Income
Financial Income / Expense
Tax Rate Share Count Q1:16
12
Cash and Marketable Securities
(in Billions) 3/31/16 12/31/15
Cash and Marketable Securities $5.71 $6.55
• Cash flow from operations was approximately $975M during Q1:16• In Q1:16, purchased $1.4B of shares
• $2 5B remaining under existing stock repurchase program• $2.5B remaining under existing stock repurchase program
13
Updating 2016 Guidance
Previous 2016 Guidance Updated 2016 Guidance
REVLIMID® $6 6B $6 7B $6 7BREVLIMID® $6.6B - $6.7B $6.7B
POMALYST® $1B+ $1B+
ABRAXANE® $1B+ $950M-$1BABRAXANE $1B+ $950M-$1B
OTEZLA® $1B+ $1B+
Total Net Product Sales $10.5B - $11.0B $10.75B - $11.0B
Adjusted Operating Margin ~53.5% ~53.5%
Adjusted Diluted EPS $5.50 - $5.70 $5.60 - $5.70
14
Note: Updated 2016 guidance assumes weighted average diluted share count of 811M
Sustained High-Growth Momentum Expected
2016 Updated Guidance
2017 Updated Targets
2020 TargetsUpdated Guidance
Y/Y GrowthUpdated Targets
Y/Y GrowthTargets
CAGR (’15-’20)
Total Net Prod ct Sales 19% 18% 18%Total Net Product Sales 19% 18% 18%
Adjusted Diluted EPS 20% 22% 23%Adjusted Diluted EPS 20% 22% 23%
15
Note: At current currency exchange ratesGrowth calculations at the mid-point of the range
Updated 2017 Financial Targets
Updated 2016 Guidance
Updated 2017 Targets ∆ vs. 20161
REVLIMID® $6 7B ~$8B +19%REVLIMID® $6.7B ~$8B +19%
ABRAXANE® $950M-$1B ~$1B +3%
Total Net Product Sales $10.75B - $11.0B $12.7B - $13.0B +18%
Adjusted Diluted EPS $5.60 - $5.70 $6.75 - $7.00 +22%
Weighted Avg. Diluted Shares 811M 825M2
16
1. Calculated using the mid-point of the range2. Reflects accounting standard change effective 1/1/2017 which eliminates a favorable adjustment currently provided in diluted share count under existing accounting guidance.Note: At current currency exchange rates
2020 Targets On-Track at Current F/X Rates
Net Product Sales($B)
Adjusted EPS($)
>$21 >$13.0023%18%CAGR
>$2123%CAGR
$23%CAGR
$9.2 $4.71
2015 2020E 2015 2020E
17
Note: At current currency exchange rates
Jackie Fouse
Q1 2016 Hematology & Oncology Franchise Results
– Q1:16 net sales growth of +15% Y/Y, +17% excluding negative F/XLeading myeloma portfolio globally
Strong Net Product Sales and Franchise Operating MomentumStrong Net Product Sales and Franchise Operating Momentum
– Leading myeloma portfolio globally– NDMM launch continues in Europe and Japan
2016 Product Growth Drivers On-Track2016 Product Growth Drivers On-Track
– Duration and market share trends continue to grow– Adoption of clinical data supporting the backbone role of REVLIMID® and POMALYST® in MM– Global NDMM reimbursement plan on-track
– FUSIONTM program advancing; partnered programs with luspatercept, AG-221 and AG-120 enrolling– Building CAR-T portfolio through Juno opt-in on CD19 and bluebird bio opt-in on BCMA
Long-term Growth Drivers Advanced in Q1Long-term Growth Drivers Advanced in Q1
19
Building CAR T portfolio through Juno opt in on CD19 and bluebird bio opt in on BCMA– ABRAXANE® apact® trial completed enrollment
Expanding Leadership in Multiple Myeloma
C l D
Building on the IMiD® Backbone Across All Lines of Multiple Myeloma
NDMM
CELMoDs®: CC 122
Celgene Drugs in Development SCT
Induction SCT
Maintenance NSCT2L 3L+
CC-122CC-220
I/O Combos:DurvalumabBCMA CART
Anti-CD47NK Cells
High Risk / Aggressive
Disease
RVd+/- Mab
RVdRd + Mab
R + Ixa, R + Dara
PdPd + PI
P Triplets
R TripletsNK Cells
Next-Gen HDACs:Ricolinostat
Next-Gen PI’s:Marizomib
Standard Disease
Aggression
Pd + MabRVdRd + Mab
RRd RVd Rd + Mab
P Triplets
20Note: Reflects currently approval and combinations under investigation
U.S. and EU-5 Overall Multiple Myeloma Market Share
Significant growth opportunities exist in the multiple myeloma market• Significant growth opportunities exist in the multiple myeloma market– Triplet combinations and continuous therapy / maintenance will drive increases in duration– Share gains with new patient segment approvals (NDMM and post-ASCT maintenance)– Epidemiology grows with aging population and new therapies expanding the prevalent pool
3%67%
% 52%
Overall MM Market Share
53%35% 44%
11%
16%8%
12%
51% 52%44%
35% 32%
IMiD PI* IMiD PI*EU-5U.S.
Notes: * PI = Proteasome Inhibitors Other (non-IMid & non-PI) are not shown.Market shares sum to greater than 100% due to combination therapiesU.S. based on March 2016 PSL audit; R6M; EU-5 based on FY 2015 internal share calculation
REVLIMID®
POMALYST®
THALOMID®
bortezomibcarfilzomib
21
Q1 2016 REVLIMID® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q1:16 sales $1,574M; +17% Y/Y (+19% excluding negative F/X)
Sales ($M)
$1 343
$1,574
• U.S. NDMM new patient market share has grown 9% since approval; EU uptake in early launch countries continues to be strong
• 2016 growth drivers on-track $532
$577
$1,003$1,144
$1,343
NDMM Launch in Japan beginning Duration trends continue to grow globally
• Future growth drivers advancing– Top-line data from REMARC data expected in mid-2016
$811$997
$435 $502
– AUGMENT® on-track to complete enrollment by YE– RELEVANCE® data in H1:17 $568 $642
$811
Q1 13 Q1 14 Q1 15 Q1 16
22
Q1:13 Q1:14 Q1:15 Q1:16
US ROW
Momentum in the U.S. MM Market for REVLIMID® Continues to Grow
Vd control arms from Vd control arms from ASH 2015 and SWOG ASH 2015 and SWOG Updated mSMART & Updated mSMART & ENDEAVOR/PANORAMAENDEAVOR/PANORAMA
Q1 - 2015 Q2 - 2015 Q3 - 2015 Q4 - 2015 Q1 - 2016 Q2 - 2016 Q3 - 2016 Q4 - 2016
data releasedata releasepNCCN GuidelinespNCCN Guidelines
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016
Rd approval in ndMM
Rd approval in ndMM
Ph III Rd+X readouts and FDA approvals
Ph III Rd+X readouts and FDA approvals
Rd+X clinical experience, later line market i REVLIMID® h ll
Rd+X clinical experience, later line market i REVLIMID® h llndMMndMM FDA approvalsFDA approvals expansion REVLIMID® re-challengeexpansion REVLIMID® re-challenge
23
EMEA REVLIMID® NDMM Performance Market Share
®®Strong REVLIMID® NDMM launch across early launch countries Expecting new markets and momentum to continue through 2016Strong REVLIMID® NDMM launch across early launch countries
Expecting new markets and momentum to continue through 2016
24% 16%
Dyn
amic
MS
(%)
Dyn
amic
MS
(%)Germany Spain
10%
19% 20% 21%
5%
8%
11%
16%
D D
Q1:15 Q2:15 Q3:15 Q4:15 Q1:16 Q1:15 Q2:15 Q3:15 Q4:15 Q1:16
24%26%
Dyn
amic
MS
(%)
Dyn
amic
MS
(%)Austria
Nordics
7%
14%
20%
24%
8%
14%
21%
D D
Reimbursement securedSource: Celgene Market Research; * Preliminary market share
1%
Q1:15 Q2:15 Q3:15 Q4:15 Q1:16*
1%
Q1:15 Q2:15 Q3:15 Q4:14 Q1:16*
24
Q1 2016 POMALYST®/IMNOVID® Sales Summary
$274Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q1 2016 sales $274M; +38% Y/Y• Successful global launch of POMALYST®/IMNOVID®
ti
Sales ($M)
$70
$103
$136
$199continues
– Global demand continues to grow from market share and duration
– U.S. POMALYST® continues to have strong market share in 3rd line+
$129$171
$47
$29
$136– EU IMNOVID® has leading market share in 3rd line+– POMALYST® market share in Japan is 35% in 3rd line+
• 2016 growth drivers First full year of launch in Japan
D ti t d ti t i
$22
$89$129
$7
Q1:13 Q1:14 Q1:15 Q1:16
$29 Duration trends continue to increase• Future growth drivers
POMALYST®/IMNOVID® combinations with other novel agents advancingRenal impairment data and label update in U S
25
Q1:13 Q1:14 Q1:15 Q1:16
US ROW
Renal impairment data and label update in U.S. expected in Q1:17
Q1 2016 ABRAXANE® Sales Summary
$185
$223 $225Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q1:16 sales $225M; +1% Y/Y• Q1 Sales Performance Impacts
Sales ($M)
$43
$64 $81
$123
$185 ABRAXANE® continues to be the standard of care in
the U.S. for pancreatic cancer; continues to gain share in Europe
Impact in U.S. from buying patternsC titi l d i b t d l i
$142 $159 $144
$29 Competitive landscape in breast and lung remains very
challenging due to entry of novel agents• Future Growth Drivers
apact® trial enrollment complete; data expected in 2017Advancing I/O strategy in NSCLC TNBC
$94
Q1:13 Q1:14 Q1:15 Q1:16
Advancing I/O strategy in NSCLC, TNBC Significant Ph III data flow expected beginning in 2017
and continuing into 2018 and beyond with I/O combinations
26
Q1:13 Q1:14 Q1:15 Q1:16
US ROW
Strong Start to 2016
REVLIMID® and POMALYST® expanding role as backbone therapies in MMREVLIMID® net product sales guidance for 2016 now $6 7B; 2017 target now $8B
Robust Results from Key Products
REVLIMID® net product sales guidance for 2016 now $6.7B; 2017 target now ~$8B ABRAXANE® I/O data expected in 2017; 2016 guidance revised to $950M-$1B; 2017 target now ~$1B
On-Track with Key Regulatory Decisions and Clinical Data in 2016
REVLIMID® maintenance after SCT in U.S. and EU POMALYST®/IMNOVID® label update with renal impairment data in U.S. and EU Data from REMARC and CONTINUUM®
Meta-analysis of OS in post-ASCT MM patients Combinations with REVLIMID® and POMALYST® in RRMM
Over 100 Abstracts Expected at ASCO and EHAOver 100 Abstracts Expected at ASCO and EHA
Data from ABRAXANE® in TNBC
27
Scott Smith
Q1 2016 I&I Franchise Updates
– Revenue continued to accelerate through Q1:16– Strong results across performance indicators (e.g., TRx, market share, persistence)
Accelerating U.S. Performance and Momentum for OTEZLA®Accelerating U.S. Performance and Momentum for OTEZLA®
g p ( g p )– Data presented at major medical meetings continue to enhance the profile
Expanding OTEZLA®’s Global FootprintExpanding OTEZLA®’s Global Footprint– Uptake accelerating in the early launch markets of Europe and in Canada– Accelerated reimbursement approvals in EMEA; reimbursement available in 14 countries– Filed Japan NDA in Q1:16
– Executing registration program for GED-0301 in Crohn’s disease
Advancing Development of I&I PipelineAdvancing Development of I&I Pipeline
29
– Ozanimod Ph II MS 72-week and phase II UC histologic data presented at medical congresses– Ozanimod Ph II MS study results published in Lancet Neurology
Q1 2016 OTEZLA® Sales Summary
$16
$183$196Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q1:16 net sales $196M; +224% Y/YSales ($M)
$21
$10$90
$139• Increasing OTEZLA® adoption in the U.S. despite market TRx contraction (-1.2% Q/Q)
$129
$167 $175 $1
$5 $60• Performance indicators predictive of
continued strong growth
Geographic expansion advancing$59
$85
Q1:15 Q2:15 Q3:15 Q4:15 Q1:16
• Geographic expansion advancing
• New data enhancing clinical profile
30
Q1:15 Q2:15 Q3:15 Q4:15 Q1:16
US ROW
Market Dynamics Supporting Positive U.S. Launch Performance
• Repeat leader in new-to-brand share for both PsA and psoriasis; reaching 38% in PsA and 42% in psoriasis• Persistency similar to biologics and ahead of oral DMARDs
Psoriasis Market Share Surpassing Enbrel
30%35%40%45%50%
OTEZLA® 30%35%40%45%50%
PsA Market Share Continuing to Grow
0%5%
10%15%20%25%30% OTEZLA®
20%
0%5%
10%15%20%25%30%
OTEZLA 15%
ENBREL STELARA HUMIRA COSENTYX OTEZLA
• At 6 months post-index, persistence to initiated drug was similar between the OTEZLA® and biologic cohorts ® 1
ENBREL HUMIRA STELARA CIMZIAREMICADE SIMPONI OTEZLA
31
Source: Symphony Prescriber-level data through week ending 31 March 20161. S. Feldman et.al., Comparison of Persistence Between Adults With Psoriasis Initiating Apremilast or Biologics at The 2016 AMCP Managed Care & Specialty Pharmacy Annual Meeting
(OTEZLA®: 67.2%, 95% CI: 63.6–70.5 vs biologics: 68.5%, 95% CI: 66.3–70.6)1
Advancing a Robust Life Cycle Plan
Milestone Expected Timing
New Indications in Development
Trial Expected Data
Enhancing the Opportunity in PsA and Psoriasis
Milestone Expected Timing p
Q1:16Q1:16Japan NDA Filing 20162016Ankylosing SpondylitisLong-term follow-up
Q2:16Q2:16Phase IIAtopic Dermatitis
2016/172016/17Phase IIUlcerative Colitis
Q1:16Q1:16PSA-006 Phase IIIPsA biologic-naïve
201820162016Bridging Study
Once daily regimen
Ulcerative Colitis
Phase IIIBehçets Disease 20172017
32
Advancing Development of Late-Stage Clinical Assets
Advancing Pivotal Programs• GED-0301 endoscopy trial completed enrollment; data expected in 2017• GED-0301 Ph III CD registration program enrolling patients; data expected in
late 2017/early 2018O i d Ph III MS t i l l t d ll t d t t d i H1 17• Ozanimod Ph III MS trials completed enrollment; data expected in H1:17
• Ozanimod Ph III UC trial enrolling; data expected in 2018
Indication Expansion• GED 0301 UC Ph II enrolling patients• GED-0301 UC Ph II enrolling patients• Ozanimod UC Ph III and CD Ph II enrolling patients
Strategic Data Dissemination• Ozanimod MS Ph II 72-week results published in Lancet Neurology (February 12Ozanimod MS Ph II 72 week results published in Lancet Neurology (February 12,
2016) and presented at ACTRIMS (Americas Committee for Treatment and Research in MS)
• Ozanimod UC Ph II (TOUCHSTONE) trial results accepted for publication in top-tier medical journalTOUCHSTONE hi t l i d t l t ti t th ECCO (E C h ’ d• TOUCHSTONE histologic data oral presentation at the ECCO (European Crohn’s and Colitis) March 2016 congress
• Additional poster and oral presentations planned for DDW (Digestive Disease Week) May 2016 Congress
33
Propelling Growth Drivers for I&I
Continue to accelerate strong growth in the U.S. and early launch markets• Brand awareness
Maximizing the OTEZLA® Opportunity
• Enhanced access position Expand utilization in existing and new indications via robust life cycle plan
Moving Ozanimod and GED-0301 Forward in 2016 Advance ozanimod Ph III trial in ulcerative colitis Complete enrollment of ozanimod Ph II trial in Crohn’s disease Progress enrollment of GED-0301 registration trials in Crohn’s disease
Complete enrollment of GED 0301 Ph II trial in UC Complete enrollment of GED-0301 Ph II trial in UC
Complete CC-220 Ph II SLE trial
Advancing Development of the I&I Pipeline
p Complete sotatercept Ph IIb trial RPC4046 Ph II in eosinophilic esophagitis achieved primary endpoint
Mark Alles
2016 Anticipated Milestones
Financial Performance Total Net Product Sales between $10.75 to $11.0 billion1
Net REVLIMID® sales of $6.7 billion1
Adjusted operating margin of ~53.5% Adjusted EPS between $5 60 to $5 701
Clinical Data Ph III REMARC – REVLIMID® in DLCBL maintenance Ph III CONTINUUM® – REVLIMID® in CLL maintenance Ph III ETNA – ABRAXANE® in neoadjuvant BC Ph III POSTURE® long term radiographic data of OTEZLA® in AS
Regulatory Submissions/Decisions Submit REVLIMID® in U.S. and EU for maintenance post-ASCT Submit POMALYST® renal impairment data in US and EU Submit ABRAXANE® for early-stage breast cancer in EU
Adjusted EPS between $5.60 to $5.701 Ph III POSTURE® – long-term radiographic data of OTEZLA® in AS Ph III PSA-006 – OTEZLA® in biologic-naïve PsA Ph II CC-122 in NHL Ph II motolimod (VTX-2337) in SCCHN and ovarian cancer Ph II portion of tnAcity® – ABRAXANE® in TNBC Ph II OTEZLA® i AD d UC Submit OTEZLA® for PSOR in Japan
CHMP opinion on REVLIMID® for MCL
Trial Enrollment
Trial Initiations Initiate ph III trial with AG-120 in IDH1 mutant AML Initiate pivotal trial with CC 122 in NHL
Ph II OTEZLA® in AD and UC Ph II CC-220 in SLE Ph II RPC4046 in EoE Pharmacokinetic comparability study – OTEZLA® once-daily formulation
Trial Enrollment Complete enrollment in AUGMENT® – REVLIMID® in RR FL Complete enrollment in apact® – ABRAXANE® in adjuvant PanC Complete enrollment in RELIEF® – OTEZLA® in Behçet’s disease Complete enrollment in ph II trial of CC-486 + pembrolizumab in NSCLC Initiate enrollment in ph I trial of BCMA CART in RRMM
Initiate pivotal trial with CC-122 in NHL Initiate ph III trial with OTEZLA® in AD Initiate second ph III trial with GED-0301 Initiate ph III trial with RPC4046 in EoE
R&ED Initiate enrollment in ph I trial of BCMA CART in RRMM Initiate enrollment in FUSION™ program with durvalumab in NDMM,
RRMM, NHL, MDS/AML
36
File at least 8 IND’s Advance at least 2 compounds to mid-to-late stage development
1. Updated Q1:16
Q1 2016 Conference Call
April 28, 2016p ,
Appendix
Evolution of the 2017 Net Product Sales Target
$14B
Range: $13B - $14B Fx Impact:
~$800M
Current Commercial Performance
$14B
Updated Range: $12.7B - $13.0B
Original Target:
$13B
$12B$12B
2017 Target (Issued 1/13)
2017 Target (Raised 1/14)
Current Outlook @ Constant Fx
Fx Impact Revised Target (4/28/16)
39
$0
Celgene Pipeline
40
Celgene Pipeline
41
Celgene Pipeline
42
Celgene Pipeline
43
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance Post-VMP induction
MM 026Trial Name
MM-026ARUMM
Phase III
Target Enrollment 350
Design
2:1 randomizationInduction with Melphalan/prednisone/bortezomib (VMP)
for 6-9 cyclesArm A: REVLIMID® (10mg) d 1-21
for 28-day cycleArm B: Placebo d 1 21 for 28 day cycleArm B: Placebo d 1-21 for 28-day cycle
Primary Endpoint Progression Free Survival
Status Trial enrolling
44
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance in ASCT EligibleTrial Name MYELOMA XI
Phase III
Target Enrollment 3 970Target Enrollment 3,970
Arm A: Cyclophosphamide (500mg) d1,8,15; THALOMID® (100mg d1-21 then 200mg daily), Dexamethasone (40mg) d1-4, 12-15 for minimum of 4 21-day cycle
Arm B: REVLIMID® (25mg) d 1-21, Cyclophosphamde (500mg) d1,8, dexamethasone (40mg) d1-4,12-15 for minimum of 4 28-day cycles
Arm C: Cyclophosphamde (500mg) d1,8, Carfilzomib (20 mg/m2) d 1,2 cycle 1 then
Design
y ( g) ( g ) y(36 mg/m2) d 1,2,8,9,15,16, REVLIMID® (25mg) d1-21, Dexamethasone (40mg) d 1-4,8,9,15,16 for 4 21-day cycles
Patients with no change, progressive disease, PR or MR randomized toArm A: Bortezomib (1.3mg/m2) d 1,4,8,11, Cyclophosphamide (500mg) d 1,8,15, Dexamethasone (20mg) d 1,2,4,5,8,9,11,12 for
max of 8 21-day cyclesArm B: No treatmentAll patients go to SCT
After SCT randomization to:Arm A: REVLIMID® (10mg) d 1-21 for 28-day cycle to disease progression
Arm B: No maintenance
Primary Endpoint Overall Survival and Progression Free Survivaly p g
Status Trial enrolling
45
POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs
Patient Population RRMM
Trial NameMM-007
OPTIMISMM®
Phase III
Target Enrollment 782
Design
Arm A: POMALYST®/IMNOVID® (4mg), bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to disease
progressionArm B: Bortezomib (1.3 mg/m2 IV) and low-dose
dexamethasone to disease progression
Primary Endpoint Progression Free Survival
Status Trial enrolling; Data in 2018E
46
MDS/AML/MF Late Stage Programs
Patient Population Low risk/INT-1 transfusion-dependent MDS Elderly Newly Diagnosed AML
MoleculeCC-486
(Oral Azacitidine)VIDAZA®
(azacitidine)
Trial Name AZA-MDS-003 AZA-AML-001
Phase III III
Target Enrollment 386 488
DesignArm A: CC-486 (150mg or 200mg)
Arm A: VIDAZA®
(75 mg/m2 SC) daily for D1-7 of a 28-day cycle until disease progressionDesign
Arm B: Placebo Arm B: Conventional Care Regimen (intensive chemotherapy, low-dose cytarabine or best supportive
care) to disease progression
Primary Endpoint RBC-transfusion independence for more than 12 weeks Overall Survival
Status Trial enrollingData presented at EHA 2014 and ASH 2014
Approved in EU Dec 2015
47
MDS/AML/MF Late Stage Programs
Patient Population Post induction AML Maintenance Anemia in to Very Low-, Low-, or Intermediate-Risk MDS
MoleculeCC-486
(oral azacitidine)Luspatercept
T i l N TMTrial Name CC-486-AML-001 MEDALISTTM
Phase III III
Target Enrollment 460 210
DesignArm A: CC-486 (150mg or 200mg)
Arm B: Best Supportive Care
Arm A: Luspatercept (Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks
Arm B: Placebo (Subcutaneous injection every 3 weeks))
Primary Endpoint Overall Survival Red Blood Cell Transfusion Independence (RBC-TI) ≥ 8 weeks
Status Trial enrolling Trial enrolling
48
MDS/AML/MF Late Stage Programs
Patient Population Red Blood Cell Transfusion Dependent Beta-Thalassemia IDH2 Mutant AML
Molecule Luspatercept AG-221 (CC-90007)
T i l N BELIEVETM IDHENTIFYTMTrial Name BELIEVETM IDHENTIFYTM
Phase III III
Target Enrollment 300 280
DesignArm A: Luspatercept (1mg/kg plus Best Supportive
CareArm B: Placebo plus Best Supportive Care
Arm A: AG 221 (100 mg daily , 28-day cycle) + Best supportive care
Arm B: Best supportive care
Proportion of subjects with hematological improvement from Week 13 to Week 24 compared
Primary Endpointimprovement from Week 13 to Week 24 compared
to 12-week prior to randomizationHematological improvement from Week 13 to Week
24 compared to the 12-week.
Overall survival
Status Trial enrolling Trial enrolling
49
REVLIMID® Chronic Lymphocytic Leukemia Late Stage Program
Patient Population Maintenance in 2nd Line CLL
Trial NameCLL-002
CONTINUUM®
Phase III
Target Enrollment 400
DesignArm A: REVLIMID® (starting dosage 2.5mg/day escalated to
10mg/day) until disease progression - 28-day cycleArm B: Placebo
Primary Endpoint Overall Survival and ProgressionFree Survival
StatusEnrollment complete
Data in 2016EData in 2016E
50
REVLIMID® Lymphoma Late Stage Programs
Patient Population Maintenance in Patients with DLBCL responding to R-CHOP to induction therapy Newly Diagnosed Follicular Lymphoma
Trial Name REMARC RELEVANCE®
Phase III III
Target Enrollment 621 1,000
DesignArm A: REVLIMID® D1-21 of 28-day
cycle for 24 monthsArm B: Placebo D1-21 of 28-day
cycle for 24 months
Arm A: REVLIMID® (starting dose 20mg) D2-22 for up to 18 28-day cycles and Rituximab (starting
dose 375 mg/m2) weekly for up to 12 28-day cyclesArm B: Physician’s choice of rituximab-CHOP, rituximab-CVP cycle for 24 months or rituximab-bendamustine
Primary Endpoint Progression Free Survival Complete Response Rate and Progression Free Survival
E ll t l t E ll t l tStatus
Enrollment completeData in 2016E
Enrollment completeData in 2017E
51
REVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Follicular Lymphoma Untreated Activated B-Cell DLBCL
Trial NameAUGMENTTM
NHL-007ROBUST®
DLC-002
Phase III III
Target Enrollment 500 560
Design
Arm A: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 2-5 for 5
28-day cyclesArm B: Placebo D1-21, / Rituximab 375 mg/m2 weeklyfor cycle 1 then D 1 of cycles 2-5 for 5 28-day cycles
Arm a: REVLIMID® (15mg) D1-14/+ R-CHOP21 for 6 21-day cycles
Arm B: Placebo + R-CHOP21 for 6 cycles
Primary Endpoint Progression Free Survival Progression Free Survival
StatusTrial enrollingData in 2017E
Trial enrolling
52
REVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Indolent Lymphoma
Trial NameMAGNIFYTM
NHL 008NHL-008
Phase III
Target Enrollment 500
Arm A: REVLIMID® (10 20mg) D1 21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 3 5 7 9 and
Design
Arm A: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 3, 5, 7,9 and 11 for 12 28-day cycles followed by REVLIMID® (10mg) D1-21 / Rituximab 375 mg/m2 D 1 of cycles 13, 15,
17,19, 21, 23, 25, 27 and 29 for 18 28-day cycles followed by REVLIMID® (10mg) D 1-21 until disease progression – 28 day cycle
Arm B: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 3, 5, 7,9 and 11 for 12 28-day cycles followed by REVLIMID® (10mg) D1-21 / Rituximab 375 mg/m2 D 1 of cycles 13, 15,
17,19, 21, 23, 25, 27 and 29 for 18 28-day cycles y y
Primary Endpoint Progression Free Survival
St tStatus Trial enrolling
53
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population Maintenance After Induction in Squamous Non-Small Cell Lung Cancer
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
Trial Name NSCL-003PANC-003
apact®
Phase III III
Target Enrollment 540 800
Induction: ABRAXANE® (100 mg/m2) D 1, 8,
Design
and 15 / Carboplatin (6 mg min/mL) D 1 for 4 21-day cyclesMaintenance:
Arm A: ABRAXANE® (100 mg/m2) D 1 and 8 plus BSC until disease progression –
21-day cycle
Arm A: ABRAXANE® (125 mg/m2) / Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28-day cycles
Arm B: Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28-day cycles.
21 day cycleArm B: BSC until disease progression
Primary Endpoint Progression Free Survival Disease Free Survival
E ll t l tStatus Trial enrolling
Enrollment completeData in 2017E
54
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population First-Line Triple Negative Metastatic Breast Cancer First Line Stage IIIB / IV Squamous NSCLC
Trial NametnAcity®
ABI-007-MBC-001NSCL-003
Abound.sqm®q
Phase II/III III
Target Enrollment 240/550 260
Phase IIA A ABRAXANE® 1(25 / 2) / G it bi (1000 / 2) D 1
Design
Arm A: ABRAXANE® 1(25mg/m2) / Gemcitabine (1000 mg/m2) D 1 and 8 – 21-day cycle
Arm B: ABRAXANE® (125mg/m2) / Carboplatin AUC 2 IV, D 1 and 8 – 21-day cycle
Arm C: Gemcitabine (1000 mg/m2) / Carboplatin AUC 2 IV, D 1 and 8 – 21-day cycle
Phase III
Arm A: Induction – ABRAXANE® (100 mg/m2) D 1, 8 and 15 / Carboplatin (6 mg/min/ml) D 1 of a 21-day cycle;
Maintenance – ABRAXANE® (100 mg/m) D 1 and 8 of a 21-day cycle or Best supportive care
Arm B: Induction – ABRAXANE® (100 mg/m2) D 1, 8 and 15 / Carboplatin (6 mg/min/ml) D 1 of a 21 day cycle;Phase III
Arm 1: Selected phase II ABRAXANE® armArm 2: Gemcitabine (1000 mg/m2) / Carboplatin AUC 2 IV, D 1
and 8 – 21-day cycle
/ Carboplatin (6 mg/min/ml) D 1 of a 21-day cycle; Maintenance – Best supportive care
Primary Endpoint Progression Free Survival Progression Free Survival
Status Trial enrollingTrial enrollingData in 2017E
55
I&I Late Stage Programs
Patient Population Untreated Moderate-to-SevereLate Stage Psoriatic Arthritis Active Behçet’s Disease
Molecule OTEZLA® OTEZLA®Molecule OTEZLA OTEZLA
Trial Name PSA-006BCT-002RELIEFTM
Phase III III
Target Enrollment 214 204
DesignArm A: OTEZLA® single agent (30mg)
twice dailyArm B: Placebo
Arm A; Placebo for 12 weeks followed by 30mg OTEZLA® twice daily for 52-weeksArm B: 30mg OTEZLA® twice daily for 64
weeks
Primary Endpoint ACR 20 at Week 16Area under the curve (AUC) for the number of oral ulcers from baseline through week
12
StatusPrimary endpoint met
Data at an major medical congressTrial enrollingD i 2017EData at an major medical congress
expected Data in 2017E
56
I&I Late Stage Programs
Patient Population Active Crohn’s Disease Active Crohn’s Disease
Molecule GED-0301 GED-0301
Trial Name CD-002 CD-003
Phase III III
Target Enrollment 1,064 1,300
Arm A: GED 301 160mg daily 12 weeks/GED 301
Design
Arm A: GED-301 160mg daily 12 weeks/GED-301 40mg daily 40 weeks
Arm B: GED-301 160mg daily 12 weeks/GED-301 40mg daily 4 weeks on/4 weeks off 40 weeks
Arm C: GED-301 160mg daily 12 weeks/GED-301 160mg daily 4 weeks on/4 weeks off 40 weeks
Arm A: GED-301 160mg daily 12 weeks/GED-301 40mg daily 40 weeks
Arm B: GED-301 160mg daily 12 weeks/GED-301 40mg daily 4 weeks on/4 weeks off 40 weeks
Arm C: GED-301 160mg daily 12 weeks/GED-301 160mg daily 4 weeks on/4 weeks off 40 weeks160mg daily 4 weeks on/4 weeks off 40 weeks
Primary Endpoint Clinical remission defined by Crohn's Disease Activity Index (CDAI)
Clinical remission defined by Crohn's Disease Activity Index (CDAI)
StatusEnrolling
Data in 2018EEnrolling
Data in 2018E
57
I&I Late Stage Programs
Patient Population Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis
Molecule Ozanimod Ozanimod
Trial Name SUNBEAM RADIANCE
Phase III II/III
Target Enrollment 1200 1200
DesignArm A: Ozanimod (0.5mg) daily/placebo IM weeklyArm B: Ozanimod (1mg) daily/placebo IM weekly
C O / f
Phase IIArm A: Ozanimod (0.5mg) dailyArm B: Ozanimod (1mg) daily
Arm C: Placebo dailyPhase III
Arm C: Oral placebo daily/Beta-interferon IM weeklyArm A: Ozanimod (0.5mg) daily/placebo IM weeklyArm B: Ozanimod (1mg) daily/placebo IM weekly
Arm C: Oral placebo daily/Beta-interferon IM weekly
Primary Endpoint Annualized relapse rate at month 12 Annualized relapse rate at month 24
StatusEnrollment complete
Data expected in H1:17Enrollment complete
Data expected in H1:17
58
I&I Late Stage Programs
Patient Population Moderate to Severe Ulcerative Colitis
Molecule OzanimodMolecule Ozanimod
Trial Name TRUE NORTH
Phase III
Target Enrollment 900Target Enrollment 900
DesignArm A: Ozanimod 1mg (daily for induction and maintenance)
Arm B: Placebo (induction and maintenance)
Primary EndpointClinical remission assessed by Mayo component sub-scores
at week 10Clinical remission assessed by Mayo component sub-scores
at week 52
E lliStatus
EnrollingData in 2018E
59
Reconciliation Tables
Reconciliation Tables
55.2
25.6
80.8
04.0
06.0
29.2
63.6
19.0
21.8
59.0 9.0 49.2) 8.3 27.1
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ed t
2016
2015
2,494.
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7
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CeRe
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63
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ighted
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impairm
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this pr
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