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Q3 2015 Conference CallNovember 5, 2015
Participants
Bob Hugin, Chairman & Chief Executive Officer
Peter Kellogg, Chief Financial Officer
Jackie Fouse President Global Hematology & OncologyJackie Fouse, President, Global Hematology & Oncology
Terrie Curran, President, Americas I&I
Mark Kreston, Corp. VP, Global Marketing I&I
Mark Alles, President & Chief Operating Officer
2
Q&A
Forward Looking Statements and Adjusted Financial Information
This presentation contains forward-looking statements, which are generally statements that are nothistorical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,”“believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking, , , p , , p gstatements are based on management’s current plans, estimates, assumptions and projections, andspeak only as of the date they are made. We undertake no obligation to update any forward-lookingstatement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict andare generally beyond our control Actual results or outcomes may differ materially from those impliedare generally beyond our control. Actual results or outcomes may differ materially from those impliedby the forward-looking statements as a result of the impact of a number of factors, many of whichare discussed in more detail in our Annual Report on Form 10-K and our other reports filed with theSecurities and Exchange Commission.
In addition to financial information prepared in accordance with U.S. GAAP, this presentation alsocontains adjusted financial measures that we believe provide investors and management withsupplemental information relating to operating performance and trends that facilitate comparisonsbetween periods and with respect to projected information. These adjusted financial measures arenon-GAAP and should be considered in addition to but not as a substitute for the informationnon GAAP and should be considered in addition to, but not as a substitute for, the informationprepared in accordance with U.S. GAAP. We typically exclude certain GAAP items thatmanagement does not believe affect our basic operations and that do not meet the GAAP definitionof unusual or non-recurring items. Other companies may define these measures in different ways.Further information relevant to the interpretation of adjusted financial measures, and reconciliations
f th dj t d fi i l t th t bl GAAP b f d
3
of these adjusted financial measures to the most comparable GAAP measures, may be found onCelgene’s website at www.Celgene.com in the “Investor Relations” section.
Bob Hugin
Q3 2015: Continued Focus on Innovative Therapies for Future Growth
Strong Financial ResultsStrong Financial Results
– Top-line and bottom-line growth; +18% Y/Y Revenue, +27% adjusted EPS– 2015 guidance for REVLIMID® and ABRAXANE® updated
– Growth of key products driven by increased market share and duration
Key Drivers for Industry Leading Growth On-TrackKey Drivers for Industry Leading Growth On-Track
– Successfully executing on key drivers to support 2020 targets
Investing in Next Generation Growth DriversInvesting in Next Generation Growth Drivers
– Over 50 clinical trials expected to begin in the next 12 months– Receptos acquisition closed; Clinical programs advancing
gg
5
Peter Kellogg
Q3 2015 Financial Highlights
E ceptional Q3 Res lts Across the PortfolioE ceptional Q3 Res lts Across the PortfolioExceptional Q3 Results Across the PortfolioExceptional Q3 Results Across the Portfolio
Strong Execution on New Product ApprovalsStrong Execution on New Product Approvals
Investment in Next-Generation Growth DriversInvestment in Next-Generation Growth Drivers
Executing a Balanced Capital Allocation StrategyExecuting a Balanced Capital Allocation Strategy
7
Executing a Balanced Capital Allocation Strategy Executing a Balanced Capital Allocation Strategy
Total Net Product Sales(Growth Rates = Growth vs. Prior Year Period)
$2,313
$1,644
$1,957
s $1,644
$ M
illio
ns
↑18% ↑19% ↑18%
Q3:13 Q3:14 Q3:15
8
Volume Drove Q3 2015 Growth
Contribution to Q3:15 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
$2,500 ↑18.2%↓1.5%↑16.1% ↑3.6%
$1,500
$2,000
llion
s
$1,000
$ M
i
$0
$500
$0Q3:14 Volume Price Fx / Hedge Q3:15
9
Adjusted Diluted Earnings Per Share(Growth Rate = Growth vs. Prior Year Period)
$1 23
$0.97
$1.23
e
$0.78
Per S
hare
↑21% ↑24%Dol
lars
↑27%
Q3:13 Q3:14 Q3:15
10
Footnote: Adjusted EPS is split-adjusted for Q3:13
Key P&L Line Items (Adjusted)
Q3:15 ∆ vs. ∆ vs.Q3:15 Q3:14 Q2:15
Product Gross Margin 95.6% ↑20 bps ↓30 bps
R&D expenses% of revenue
$488M 20.9%
↓20 bps ▬
SG&A expenses $474MSG&A expenses% of revenue
$474M 20.3%
↓200 bps ↓340 bps
Operating Margin 54.5% ↑250 bps ↑320 bps
Effective Tax Rate 13.7% ↓250 bps ↓300bps
11
Q3 2015 Adjusted Diluted EPS Growth Driven by Increased Operating Income
Contribution to Q3:15 Adjusted Diluted EPS
$1.23$0.24$0.97 $0.04 $0.01($0.03)
hare
llars
Per
Sh
Q3:14 Operating Financial Tax Rate Share Q3:15
Dol
Q3:14 Operating Income
Financial Income / Expense
Tax Rate Share Count
Q3:15
12
Cash and Marketable Securities
(in Billions) 9/30/15 12/31/14( )
Cash and Marketable Securities $7.51 $7.55
• Cash flow from operations was approximately $285M during Q3:15
I Q3 15 h d $815M f h YTD h d $2 8B f h• In Q3:15, purchased $815M of shares; YTD, purchased $2.8B of shares– $4.3B remaining under stock repurchase program at 9/30/15
• In Q3:15 issued aggregate of $8B in unsecured notes for the Receptos transaction and general corporate purposes
13
Focused on Returns
35.0%$20.0
ROIC
25.0%
30.0%
$14.0
$16.0
$18.0
15.0%
20.0%
$8.0
$10.0
$12.0
Bill
ion
5.0%
10.0%
$2.0
$4.0
$6.0$
Average Invested Capital0.0%$0.0
2009 2010 2011 2012 2013 2014 2015 (TTM)
Capital Base Excluding Cash* Capital Base ROIC Excluding Cash* ROIC
Average Invested Capital
14
*For purposes of this calculation, cash includes cash and cash equivalents and marketable securities available for sale.
Footnote: Financial performance is based on GAAP operating income adjusted to reflect amortization of certain charges excluded from 2008 calculation and tax impact. Calculation for TTM 2015 includes expenses driven by the Juno Therapeutics and AstraZeneca collaborations and expenses incurred in connection with the acquisition of Receptos as well as the impact of the August 2015 debt issuance on the capital base. Refer to reconciliation tables for complete calculation methodology. Calculation revised in 2015 for all prior periods to reflect amortization of certain charges excluded from 2008 calculation.
Q3 2015 Summary
E ceptional Q3 Res lts Across the PortfolioE ceptional Q3 Res lts Across the PortfolioExceptional Q3 Results Across the PortfolioExceptional Q3 Results Across the Portfolio
Strong Execution on New Product ApprovalsStrong Execution on New Product Approvals
Investment in Next-Generation Growth DriversInvestment in Next-Generation Growth Drivers
Executing a Balanced Capital Allocation StrategyExecuting a Balanced Capital Allocation Strategy
15
Executing a Balanced Capital Allocation Strategy Executing a Balanced Capital Allocation Strategy
Jackie Fouse
Q3 2015 Hematology & Oncology Franchise Results
– Q3:15 net sales growth of +12% Y/Y, +14% operational
Strong Product Sales and Franchise Operating MomentumStrong Product Sales and Franchise Operating Momentum
g , p– Excellent REVLIMID® and POMALYST®/IMNOVID® performance
2015 P d t G th D i O T k2015 P d t G th D i O T k– Strong uptake in the U.S. and initial EU markets for REVLIMID® in NDMM– Reimbursement progress in key markets for REVLIMID® NDMM,
2015 Product Growth Drivers On-Track2015 Product Growth Drivers On-Track
ABRAXANE® PanC and POMALYST®/IMNOVID® in RRMM– Japan POMALYST® launch ongoing
– Luspatercept and AG-221 moving into pivotal trials by year-end– 5 phase III studies with REVLIMID® in NHL advancing
Investing in Next Generation Growth DriversInvesting in Next Generation Growth Drivers
17
p g– Collaboration programs with AstraZeneca and Juno moving forward
Q3 2015 REVLIMID® Net Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q3:15 sales $1,453M; +12% Y/Y, +14% Sales ($M)
$1 444 $1 453, ; ,operational
• Raising REVLIMID® 2015 net product sales guidance to approximately $5.8B
• Market shares and duration of treatment are $532
$571 $558
$1,322 $1,343$1,444 $1,453
• Market shares and duration of treatment are strong across the world
• Progress on 2015 commercial drivers– EU NDMM reimbursement on-track; Germany
d S i d R t f G5 t d b
$525 $532
and Spain secured; Rest of G5 expected by H1:16
– Russia Federal RRMM tender received in Q2; Expected in Q4
– ASH data supports triplet regimen landscape$797 $811 $873 $895
ASH data supports triplet regimen landscape with REVLIMID® as backbone
• Future growth drivers advancing NDMM approval in Japan on-track for YE15 NHL program advancing Q4:14 Q1:15 Q2:15 Q3:15
18
Geographic expansion in Latin America continues U.S. ROW
Strong Initial U.S. REVLIMID® NDMM Launch
• Daily TRx reached highest ever quarterly average in Q3:15• REVLIMID® expanding its leading market share in NDMM
New NDMM Patient Share
• Duration increasing across all lines of therapy
63%
s 54%
45%
of p
atie
nts
47%
% o
Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15
REVLIMID bortezomib
19
*Share adds up to more than 100% due to combination therapy
EU REVLIMID® NDMM Launch DynamicsMarket Share in Early Access Country Germany Driving Performance
Market Share (Q2 EU5)
* NSCT – Non-stem cell transplant eligible
20
Q3 2015 POMALYST®/IMNOVID® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers$257• Q3:15 sales $257M; +42% Y/Y +41%
Sales ($M)
$91$107
$202 $199
$235• Q3:15 sales $257M; +42% Y/Y, +41%
operational
• Positive trends in U.S. and EU market share with growing duration
$70 $70 $91
• Progress on 2015 growth drivers Reimbursement in Italy secured in Q3 Negotiations in additional countries
ongoing
$132 $129 $144 $150
ongoing Japan launch underway; strong initial
uptake• Future growth drivers advancing
N t i l ith l t i iti t d
Q4:14 Q1:15 Q2:15 Q3:15
New trials with novel agents initiated including PD-1/PD-L1 compounds, monoclonal antibodies, HDAC inhibitors and proteasome inhibitors
21
U.S. ROW
Rapid POMALYST® Uptake in Japan
Over 1,000 new patients treated with POMALYST® since May Launch3rd line + share has quickly passed 20%
3rd Line+ Market Share
POMALYST®
40%
POMALYST20.1%20.7%
20.1%20%
30%
30.2%
14 5%
14.5%
16.7%
0%
10%
14.5%
POMALYST REVLIMID THALOMIDbortezomib OtherFeb Apr Jun Aug
POMALYST
22
bortezomib Other
Q3 2015 ABRAXANE® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
+13%+18%*• Q3:15 sales $230M; +8% Y/Y, +8%
operational
Sales ($M)
+21%+13% +8%operational
• 2015 ABRAXANE® net product sales guidance now $950M-$1.0B, ~+15% Y/Y*
• U.S. dynamics A pancreatic cancer standard of care;
Competitive dynamics in NSCLC and mBC
• ROW dynamicsROW
y EU launch in pancreatic cancer continues
to expand; Launching in early access markets for NSCLC
• Future growth drivers advancingUS
g g Combination phase III trials with PD-L1 in
NSCLC and TNBC enrolling; Phase I data in TNBC expected at SABCS Q1 Q2 Q3 Q4*
23
• Q4:15 and Y/Y growth based on mid-point of revised guidance range
2014 2015
124 ASH 2015 Submitted Abstracts
TOPIC MM Myeloid Disease NHL/CLL TOTAL
REVLIMID® 39 14 14 67REVLIMID® 39 14 14 67
POMALYST®/IMNOVID® 18 2 20
VIDAZA® 11 11
CC-122 4 4
CC-486 1 1
Luspatercept 3 3
Sotatercept 1 1 2
AG-221 2 2
AG-120 2 22 2
Other 3 1 4
Disease 2 6 8
TOTAL 63 36 25 124TOTAL 63 36 25 124
24
ASH 2015 Submitted Abstracts
TOPIC MM Myeloid Disease NHL/CLL TOTAL
REVLIMID® 39 14 14 67• Phase III cooperative group SWOG S0777 trial comparing
RVd Rd NDMM t i t d d f i di t t lREVLIMID® 39 14 14 67
POMALYST®/IMNOVID® 18 2 20
VIDAZA® 11 11
RVd vs. Rd NDMM not intended for immediate autologous stem cell transplant
• REVLIMID® in novel combinations including elotuzumab,CC-122 4 4
CC-486 1 1
Luspatercept 3 3
REVLIMID in novel combinations including elotuzumab, ixazomib and PD-1/PD-L1 compounds in MM
• Phase II trials of luspatercept in beta-thalassemia and MDSSotatercept 1 1 2
AG-221 2 2
AG-120 2 2
• Phase I/II trial AG-221 in IDH2-mutated RR AML
• Phase I trial of AG-120 in advanced hematologic 2 2
Other 3 1 4
Disease 2 6 8
TOTAL 63 36 25 124
gmalignancies
• Phase I/II trials of ACY-1215 in RRMMTOTAL 63 36 25 124
25
Strong Current Performance; Bright Future
12% Y/Y net product sales growth for Hematology & Oncology in Q3:15
Strong Operating Momentum
12% Y/Y net product sales growth for Hematology & Oncology in Q3:15 Exceptional growth from key strategic brands
Advancing Near Term Growth Drivers
Positive trends for REVLIMID® in market share and duration IMNOVID® market share in EU showing strong growth
Advancing Near-Term Growth Drivers
g g g ABRAXANE® solid position in pancreatic cancer
Key Data Inflection Points Over Next 12-24 MonthsKey Data Inflection Points Over Next 12-24 Months
Data expected from REVLIMID® lymphoma trials beginning in 2017 Triplet data in multiple myeloma with REVLIMID® and POMALYST®/IMNOVID®
ABRAXANE® as taxane of choice in key I/O combinations
Key Data Inflection Points Over Next 12 24 MonthsKey Data Inflection Points Over Next 12 24 Months
26
ABRAXANE® as taxane-of-choice in key I/O combinations
Terrie CurranMark Kreston
Q3 2015 I&I Franchise Update
R l t d th h t Q3Enhancing US Performance and Momentum for OTEZLA®Enhancing US Performance and Momentum for OTEZLA®
– Revenue accelerated throughout Q3– Strong results across performance indicators including TRx and new-to-
brand share
– Strong uptake in early launch countries in Europe
Expanding OTEZLA®’s Geographic FootprintExpanding OTEZLA®’s Geographic Footprint
– Positive registration study in Japan; progressing towards filing in H1:16
Advancing Development of I&I PipelineAdvancing Development of I&I Pipeline
– Executing registration program for GED-0301– Receptos acquisition completed; integration going well
Ph III t i l f i d i RMS f ll ll d UC t i l d
Advancing Development of I&I PipelineAdvancing Development of I&I Pipeline
28
– Phase III trials for ozanimod in RMS fully enrolled; UC trial underway
Strong Q3 2015 OTEZLA® Revenue Performance
Current Results & Future Growth Drivers Sales ($M)
• Q3:15 net sales of $139M
• Geographic expansion advancingLaunches underway in Canada Germany
$139
– Launches underway in Canada, Germany, and multiple other European markets
– Significant TRx uptake across early launch markets
$60
$90
– Reimbursement negotiations progressing
• New data enhances clinical profile– Durable efficacy and safety in patients
$47$60
Durable efficacy and safety in patients with psoriasis (LIBERATE®)
– Rapid onset of effect and significant efficacy in patients with early PsA disease (ACTIVE)
Q4:14 Q1:15 Q2:15 Q3:15(ACTIVE)
29
U.S. ROW
Market Dynamics SupportingPositive U.S. Launch Performance
US Weekly TRx
2014 2015
US Market Dynamics
OTEZLA (PsA/PSOR)
XELJANZ (RA)
CIMZIA (C h ' )
2014 2015• Continued leadership in weekly
TRx and new patient starts
• Consumer and physician i d i i i i CIMZIA (Crohn's)
SIMPONI (RA/PsA/AS)
STELARA (PsO)
campaigns driving increase in: – Brand awareness– Patient requests
Number of trialists– Number of trialists
• Market leader in new-to-brand share in PsA and psoriasis
1 14 27 40 53 66
Week Since Product Launch
• Persistency to-date similar to that of biologics and ahead of oral DMARDs
30
Note: STELARA TRx launch aligned based on 4 week trailing average; TRx reflects total number of new and refill prescriptions to-dateSource: IMS SMART, data through week ending October 2, 2015
Initiated GED-0301 Pivotal Trial in Crohn’s Disease
Study CD-002: 52 Week Treat ThroughScreening Phase
Week 12 Week 52Week 4
GED 160mg – 4 weeks on/ 4 weeks off
GED 40mg – daily
GED 40 mg – 4 weeks on/ 4 weeks off
GED 160mg (N=266)
GED 160mg (N=266)
GED 160mg (N=266)Screening
Colonoscopy
Randomization 1:1:1:1Placebo
Primary Endpoint: Clinical remission
Colonoscopy Endoscopic endpoint
Colonoscopy Endoscopic endpoint
Placebo (N=266)
• CD-001: Endoscopy study in Crohn’s disease underway; enrollment expected to complete by year-end 2015
• CD-002: Registration trial in Crohn’s disease initiated in Q3; patient randomization to begin in Q4:15
• CD-003: Registration trial in Crohn’s disease to initiate in H1:16; target completion timing similar to that of CD-002
31
timing similar to that of CD-002
• UC-001: Phase II proof of concept study in ulcerative colitis to initiate in Q4:15
Ozanimod Clinical Development Continues to Progress on or Ahead of Schedule
• Ozanimod relapsing multiple sclerosisFi t h III RMS t i l (RADIANCE) f ll ll d– First phase III RMS trial (RADIANCE) fully enrolled
– Second phase III RMS trial (SUNBEAM) fully enrolled ahead of schedule
• Ozanimod IBD– Phase II UC trial (TOUCHSTONE) induction and maintenance
results completed; 32 week results presented at ACG and UEGWresults completed; 32-week results presented at ACG and UEGW– Phase III UC trial (TRUE NORTH) patient randomization underway– Phase II Crohn’s trial (STEPSTONE) initiated
32
Powerful I&I Growth Drivers
Encouraging market dynamics in launch markets to-date Activities continuing to enhance access position
Maximizing the OTEZLA® Opportunity
g p Preparing for the next wave of global launches
Executing the GED-0301 Clinical Program
Moving Ozanimod Forward
Completing enrollment of GED-0301 registration-enabling endoscopy trial Initiating Ph III trials of GED-0301 in Crohn’s disease and Ph II trial in Ulcerative Colitis
Receptos transaction closed Ozanimod Ph III trials advancing in ulcerative colitis and multiple sclerosis Initiating Ph II clinical program in Crohn’s disease
Moving Ozanimod Forward
g p g
CC-220 – Ph II dose finding in lupus ongoing cohort 2 nearing completion
Advancing the I&I Development Pipeline
33
CC 220 Ph II dose finding in lupus ongoing, cohort 2 nearing completion Sotatercept – Ph II interim data in renal anemia to be presented at ASN CC-90001 – initiated clinical development in patients with pulmonary fibrosis
Mark Alles
Delivering Now;Investing in Long-Term Sustainable Growth
Late Stage Pipeline
Current
Late Stage Pipeline Contributing
Current Portfolio
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 202835
Q3 2015 Conference CallNovember 5, 2015
Reconciliation Tables
Reconciliation Tables
520
14
621.9
5,508
.9$
70.8
76
.0
69
2.75,5
84.9
314.7
282.7
920.5
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$
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Perio
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Septe
mber
30,
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2015
1,956
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Reconciliation Tables
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Reconciliation Tables
Explanation of adjustments:Explanation of adjustments:(1) Exclude share-based compensation expense totaling $149.9 for the three-month period ended September 30, 2015 and $111.4 for the three-month
period ended September 30, 2014. Exclude share-based compensation expense totaling $426.4 for the nine-month period ended September 30, 2015 and $319.2 for the nine-month period ended September 30, 2014.
(2) Exclude upfront payment expense for research and development collaboration arrangements.(3) Exclude in-process research and development (IPR&D) impairment recorded as a result of changes in estimated probability-weighted cash flows ( ) p p ( ) p g p y g
related to CC-292.(4) Exclude settlement of a contingent obligation to make matching contributions to a non-profit organization.(5) Exclude amortization of intangible assets acquired in the acquisitions of Pharmion Corp., Gloucester Pharmaceuticals, Inc. (Gloucester), Abraxis
BioScience Inc. (Abraxis) and Celgene Avilomics Research, Inc. (Avila).(6) Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila and Nogra Pharma Limited.(7) Exclude equity compensation and other fees and costs related to the acquisition of Receptos, Inc.(8) Exclude restructuring charges related to our relocation of certain operations into our two Summit, NJ locations.(9) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments,
including the effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits, adjustments related to the gain on the sale of an equity investment and nonrecurring items connected with the launch of new products.
(10) Diluted net income per share for the three-month period ended September 30, 2015 was determined using diluted weighted average shares of 823.6.
40
Reconciliation Tablesme
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Return on Invested Capital Calculation
Return on Invested Capital (ROIC)(amounts in thousands) Q3 2015 (TTM) 2014 2013 2012 2011 2010 2009Operating income 2,106,100 2,519,000 1,808,900 1,746,442 1,442,753 989,635 841,526
Certain charges (1)Amortization of certain charges (2) (141,000) (141,000) (141,000) (261,000) (141,000) (141,000) (141,000)
Operating income (non-GAAP for 2008) 1,965,100 2,378,000 1,667,900 1,485,442 1,301,753 848,635 700,526
Effective tax rate 16.8% 14.1% 12.9% 13.4% 7.2% 13.1% 20.4%Operating income after tax 1,635,179 2,043,380 1,452,284 1,286,401 1,208,155 737,660 557,681
Total equity 5,375,488 6,524,796 5,589,900 5,694,467 5,512,727 5,995,472 4,394,606 Certain charges net of amortization (3) 778,086 914,699 1,051,313 1,187,927 1,440,807 1,577,420 1,714,034 Total debt 15,497,605 6,871,632 4,741,269 3,079,792 1,802,269 1,247,584 -
Total capital 21,651,179 14,311,127 11,382,482 9,962,186 8,755,803 8,820,476 6,108,640
Total capital beginning of period 13,554,508 11,382,482 9,962,186 8,755,803 8,820,476 6,108,640 5,341,976 Total capital end of period 21,651,179 14,311,127 11,382,482 9,962,186 8,755,803 8,820,476 6,108,640
Average total capital 17 602 843 12 846 805 10 672 334 9 358 994 8 788 140 7 464 558 5 725 308Average total capital 17,602,843 12,846,805 10,672,334 9,358,994 8,788,140 7,464,558 5,725,308
ROIC 9.3% 15.9% 13.6% 13.7% 13.7% 9.9% 9.7%
Return on Invested Capital (ROIC), Net of Cash(amounts in thousands) Q3 2015 (TTM) 2014 2013 2012 2011 2010 2009Operating income 2,106,100 2,519,000 1,808,900 1,746,442 1,442,753 989,635 841,526
Certain charges (1)Amortization of certain charges (2) (141,000) (141,000) (141,000) (261,000) (141,000) (141,000) (141,000)
Operating income (non-GAAP for 2008) 1,965,100 2,378,000 1,667,900 1,485,442 1,301,753 848,635 700,526
Effective tax rate 16.8% 14.1% 12.9% 13.4% 7.2% 13.1% 20.4%Operating income after tax 1,635,179 2,043,380 1,452,077 1,286,401 1,208,155 737,660 557,681
Total equity 5,375,488 6,524,796 5,589,900 5,694,467 5,512,727 5,995,472 4,394,606 Certain charges net of amortization (3) 778,086 914,699 1,051,313 1,187,927 1,440,807 1,577,420 1,714,034 Total debt 15,497,605 6,871,632 4,741,269 3,079,792 1,802,269 1,247,584 - Less Cash and Marketable Securities (7,505,572) (7,546,633) (5,686,989) (3,900,270) (2,648,154) (2,601,301) (2,996,752)
Total capital 14,145,607 6,764,494 5,695,493 6,061,916 6,107,649 6,219,175 3,111,888
Total capital beginning of period 6,693,808 5,695,493 6,061,916 6,107,649 6,219,175 3,111,888 3,119,885 Total capital end of period 14,145,607 6,764,494 5,695,493 6,061,916 6,107,649 6,219,175 3,111,888
Average total capital 10,419,708 6,229,994 5,878,704 6,084,782 6,163,412 4,665,532 3,115,886
ROIC, Net of Cash 15.7% 32.8% 24.7% 21.1% 19.6% 15.8% 17.9%
(1) Excludes $1.7 billion of IPR&D expense in 2008 associated with the acquisition of Pharmion, as well as $300 millionof expense related to the acquisition of intellectual property rights for Vidaza in 2008 prior to it's launch.
44
o e pe se e ated to t e acqu s t o o te ectua p ope ty g ts o da a 008 p o to t s au c(2) Adjustment to include amortization and impairment related to IPR&D and intellectual property rights acquired in 2008.(3) Cumulative net impact of items (1) and (2) on equity.
Appendix
Key Milestones – Full-Year 2015
Franchise Milestone ExpectedTiming
Regulatory decisions on REVLIMID® for NDMM in the U.S. and EU Feb 2015
Regulatory decision on REVLIMID® for NDMM in Japan H2Regulatory decision on REVLIMID for NDMM in Japan H2
Submit REVLIMID® for non-del5q MDS in U.S. and Japan U.S. Jun 2015
Presentation of FLASH meta-analysis on durable CR in follicular NHL Jun 2015
Initiate enrollment in REVLIMID® Ph III ROBUST® trial in DLBCL Jan 2015
EU regulatory decision on ABRAXANE® in NSCLC Mar 2015
Regulatory decision on POMALYST® for RRMM in Japan Mar 2015
Complete enrollment in REVLIMID® Ph III CONTINUUM trial in CLL H2
CHMP opinion on VIDAZA® for elderly AML Sep 2015
Hematology& Oncology
CHMP opinion on VIDAZA® for elderly AML Sep 2015
Advance CC-122 in Ph I/II trials in DLBCL H2
Initiate luspatercept in Ph III trial in beta-thalassemia H2
Initiate Ph III trial with AG-221 in AML with IDH-2 mutation H2
EU regulatory decision on OTEZLA® in PSOR and PsA Jan 2015
Complete enrollment in GED-0301 registration-enabling endoscopy trial H2
Initiate enrollment in GED-0301 Ph III trials in Crohn’s disease H2
Initiate GED 0301 clinical program in ulcerative colitis H2I & I
Initiate GED-0301 clinical program in ulcerative colitis H2
Complete enrollment in CC-220 Ph II trial in SLE H2
Completion of Receptos acquisition Aug 2015
46
Celgene Pipeline
47
Celgene Pipeline
48
Celgene Pipeline
49
Celgene Pipeline
50
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance Post-VMP induction
T i l NMM-026
Trial NameARUMM
Phase III
Target Enrollment 350
Design
2:1 randomizationInduction with
Melphalan/prednisone/bortezomib (VMP) for 6-9 cycles
Arm A: REVLIMID® (10mg) d 1 21Arm A: REVLIMID® (10mg) d 1-21 for 28-day cycle
Arm B: Placebo d 1-21 for 28-day cycle
Primary Endpoint Progression Free Survival
Status Trial enrolling
51
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance in ASCT EligibleTrial Name MYELOMA XI
Phase IIIPhase III
Target 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)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 (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 cyclesPatients with no change progressive disease PR or MR randomized toDesign Patients with no change, progressive disease, PR or MR randomized to
Arm 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 cycles
Arm 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
52
POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs
Patient Population RRMM
T i l NMM-007
Trial NameOPTIMISMM®
Phase III
Target Enrollment 782
D i
Arm A: POMALYST®/IMNOVID® (4mg), bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to disease progressionDesign dexamethasone to disease progression
Arm B: Bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to disease progression
Primary Endpoint Progression Free SurvivalPrimary Endpoint Progression Free Survival
Status Trial enrolling
53
MDS/AML/MF Late Stage Programs
Patient Population Non-del5Q low risk/INT-1 transfusion-dependent MDS
Low risk/INT-1 transfusion-dependent MDS
CC 486Molecule REVLIMID®
CC-486(Oral Azacitidine)
Trial Name MDS-005 AZA-MDS-003
Phase III III
Target Enrollment 239 386g
DesignArm A: REVLIMID® (10mg)
Arm B: PlaceboArm A: CC-486 (150mg or 200mg)
Arm B: Placebo
Primary Endpoint RBC-transfusion independencefor at least 8 weeks
RBC-transfusion independence for more than 12 weeks
Primary endpoint met
Status
yData presented at ASH 2014
Submitted to FDA; PDUFA date April 16, 2016
Trial enrolling
54
MDS/AML/MF Late Stage Programs
Patient Population Elderly Newly Diagnosed AML Post induction AML Maintenance
MoleculeVIDAZA® CC-486
Molecule(azacitidine) (oral azacitidine)
Trial Name AZA-AML-001 CC-486-AML-001
Phase III III
Target Enrollment 488 460
Arm A: VIDAZA®
(75 mg/m2 SC) daily for D1-7 of a 28-day cycle until disease progression
Designcycle until disease progression
Arm B: Conventional Care Regimen (intensive chemotherapy, low-dose
cytarabine or best supportive care) to disease progression
Arm A: CC-486 (150mg or 200mg)Arm B: Best Supportive Care
Primary Endpoint Overall Survival Overall Survival
StatusData presented at EHA 2014 and ASH 2014Positive CHMP opinion; Final EU decision Trial enrollingStatus Positive CHMP opinion; Final EU decision
by YE2015ETrial enrolling
55
REVLIMID® Chronic Lymphocytic Leukemia Late Stage Programs
Patient Population Maintenance in 2nd Line CLL
Trial NameCLL-002
Trial NameCONTINUUM®
Phase III
Target Enrollment 400
D iArm A: REVLIMID® (starting dosage
2.5mg/day escalated to 10mg/day) until Design
g y g y)disease progression - 28-day cycle
Arm B: Placebo
Primary Endpoint Overall Survival and ProgressionFree Survivaly p Free Survival
StatusTrial enrolling
Enrollment to complete in 2015E
56
REVLIMID® Lymphoma Late Stage Programs
Patient PopulationMaintenance 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
Arm A: REVLIMID® (starting dose 20mg)
DesignArm A: REVLIMID® D1-21 of 28-day
cycle for 24 monthsArm B: Placebo D1-21 of 28-day
cycle for 24 months
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 or rituximab-bendamustine
Primary Endpoint Progression Free Survival Complete Response Rate and Progression Free Survival
Status Enrollment complete Enrollment completeStatus Enrollment complete Enrollment complete
57
REVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Follicular Lymphoma
Untreated Activated B-Cell DLBCL
T i l NAUGMENTTM ROBUST®
Trial NameNHL-007 DLC-002
Phase III III
Target Enrollment 500 560Target 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 cycles Arm a: REVLIMID® (15mg) D1-14/+ R-CHOP21 for 6 21-day cyclesDesign
Arm B: Placebo D1-21, / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of
cycles 2-5 for 5 28-day cycles
CHOP21 for 6 21 day cyclesArm B: Placebo + R-CHOP21 for 6 cycles
Primary Endpoint Progression Free Survival Progression Free Survival
Status Trial enrolling Trial enrolling
58
REVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Indolent Lymphoma
Trial NameMAGNIFYTM
NHL-008
Phase III
T t E ll t 500Target Enrollment 500
D i
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 cycleDesign 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
Primary Endpoint Progression Free Survival
Status Trial enrolling
59
ABRAXANE® Solid Tumor Late Stage Programs
Patient PopulationMaintenance After Induction in
Squamous Non-Small Cell Lung Cancer
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
PANC-003Trial Name NSCL-003
PANC 003apact®
Phase III III
Target Enrollment 540 800
Induction: ABRAXANE® (100 mg/m2) D 1, 8,and 15 / Carboplatin (6 mg min/mL) D 1 for
4 21-day cycles Arm A: ABRAXANE® (125 mg/m2) / Gemcitabine (1000 mg/m2) D 1 8 and 15 for
Design Maintenance: Arm A: ABRAXANE® (100 mg/m2) D 1 and
8 plus BSC until disease progression –21-day cycle
Arm B: BSC until disease progression
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.
Arm B: BSC until disease progression
Primary Endpoint Progression Free Survival Disease Free Survival
Status Trial enrolling Trial enrolling
60
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population First-Line Triple Negative Metastatic Breast Cancer
First Line Stage IIIB / IV SquamousNSCLC
tnAcity® NSCL 003Trial Name
tnAcity®
ABI-007-MBC-001NSCL-003
Abound.sqm®
Phase II/III III
Target Enrollment 240/550 260Target Enrollment 240/550 260
Phase IIArm A: ABRAXANE® 1(25mg/m2) / Gemcitabine
(1000 mg/m2) D 1 and 8 – 21-day cycleArm B: ABRAXANE® (125mg/m2) / Carboplatin
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
DesignAUC 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 IIIArm 1: Selected phase II ABRAXANE® arm
Maintenance – ABRAXANE® (100 mg/m) D 1 and 8 of a 21-day cycle or Best supportive
careArm B: Induction – ABRAXANE® (100 mg/m2) D 1, 8 and 15 / Carboplatin (6
mg/min/ml) D 1 of a 21-day cycle; pArm 2: Gemcitabine (1000 mg/m2) / Carboplatin
AUC 2 IV, D 1 and 8 – 21-day cycle
g ) y y ;Maintenance – Best supportive care
Primary Endpoint Progression Free Survival Progression Free Survival
Status Trial enrolling Trial enrolling
61
I&I Late Stage Programs
Patient Population
Untreated Moderate-to-Severe
Late Stage Psoriatic Arthritis
Active Behçet’s DiseaseArthritis
Molecule OTEZLA® OTEZLA®
Trial Name PSA-006BCT-002RELIEFTM
Ph III IIIPhase III III
Target Enrollment 214 204
Arm A: OTEZLA® single agent Arm A; Placebo for 12 weeks followed by 30mg OTEZLA®
Designg g
(30mg)twice daily
Arm B: Placebo
followed by 30mg OTEZLA®
twice daily for 52-weeksArm B: 30mg OTEZLA® twice
daily for 64 weeks
Area under the curve (AUC) forPrimary Endpoint ACR 20 at Week 16
Area under the curve (AUC) for the number of oral ulcers from
baseline through week 12
Status Trial enrolling Trial enrolling
62
I&I Late Stage Programs
Patient Population Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis
Molecule Ozanimod OzanimodMolecule Ozanimod Ozanimod
Trial Name SUNBEAM RADIANCE
Phase III II/III
Target Enrollment 1200 1200
Arm A: Ozanimod (0 5mg) daily/placebo IM
Phase IIArm A: Ozanimod (0.5mg) dailyArm B: Ozanimod (1mg) daily
Design
Arm A: Ozanimod (0.5mg) daily/placebo IM weekly
Arm B: Ozanimod (1mg) daily/placebo IM weekly
Arm C: Oral placebo daily/Beta-interferon IM weekly
Arm B: Ozanimod (1mg) dailyArm C: Placebo daily
Phase IIIArm A: Ozanimod (0.5mg) daily/placebo IM
weeklyweekly
Arm B: Ozanimod (1mg) daily/placebo IM weeklyArm 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
63
I&I Late Stage Programs
Patient Population Moderate-to-Severe Ulcerative Colitis
Molecule Ozanimod
Trial Name TRUE NORTH
Phase IIIPhase III
Target Enrollment 900
A A O i d (1 ) d ilDesign
Arm A: Ozanimod (1mg) dailyArm B: Placebo daily
Primary Endpoint Clinical remission
Status Trial enrollingStatus Trial enrolling
64