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Page 1: Q3 2015 Conference Call - s24.q4cdn.com › 483522778 › files › doc_presentations › Q3_2… · Q3 2015: Continued Focus on Innovative Therapies for Future Growth Strong Financial

Q3 2015 Conference CallNovember 5, 2015

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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

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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.

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Bob Hugin

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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

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Peter Kellogg

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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Jackie Fouse

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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

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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

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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

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EU REVLIMID® NDMM Launch DynamicsMarket Share in Early Access Country Germany Driving Performance

Market Share (Q2 EU5)

* NSCT – Non-stem cell transplant eligible

20

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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

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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

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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

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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

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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

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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

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Terrie CurranMark Kreston

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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

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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

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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

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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

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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

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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

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Mark Alles

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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

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Q3 2015 Conference CallNovember 5, 2015

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Reconciliation Tables

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Reconciliation Tables

520

14

621.9

5,508

.9$

70.8

76

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Page 39: Q3 2015 Conference Call - s24.q4cdn.com › 483522778 › files › doc_presentations › Q3_2… · Q3 2015: Continued Focus on Innovative Therapies for Future Growth Strong Financial

Reconciliation Tables

15201

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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

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Reconciliation Tablesme

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Page 43: Q3 2015 Conference Call - s24.q4cdn.com › 483522778 › files › doc_presentations › Q3_2… · Q3 2015: Continued Focus on Innovative Therapies for Future Growth Strong Financial

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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.

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Appendix

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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

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Celgene Pipeline

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Celgene Pipeline

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Celgene Pipeline

49

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Celgene Pipeline

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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