32nd annual j.p. morgan healthcare conference...2013* 2015e 2017e • establishing a new standard of...

32nd Annual J.P. Morgan Healthcare Conference

J 13 2014January 13, 2014

Forward Looking Statements and Non-GAAP 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 measures are non-GAAP and should be considered in addition to but not as a substitute for the information preparedGAAP and should be considered in addition to, but not as a substitute for, the information preparedin accordance with U.S. GAAP. We typically exclude certain GAAP items that management doesnot believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. Further informationrelevant to the interpretation of adjusted financial measures, and reconciliations of these adjustedfi i l t th t bl GAAP b f d C l ’ b it t

2

financial measures to the most comparable GAAP measures, may be found on Celgene’s website atwww.Celgene.com in the “Investor Relations” section.

Our Mission and Vision

Celgene is building a preeminent global biopharmaceutical company focused on the

discovery, development and commercialization of innovative therapies for unmet medical needs in

cancer and immune-inflammatory diseases

3

O U R F O C U S

Four Strategic Imperatives

Operational excellenceOperational excellenceOperational excellenceOperational excellence

Capitalizing on strength in HematologyCapitalizing on strength in Hematology

Building new franchises in Oncology and I & IBuilding new franchises in Oncology and I & I

Sustaining innovation and long-term growthSustaining innovation and long-term growth

4

M A J O R A C C O M P L I S H M E N T S I N 2 0 1 3 :

Exceptional Financial and Operational Performance

Operational excellence

f $ % /

Operational excellence

• Total net product sales of ~$6,362M, +18% y/y

• Net REVLIMID sales of ~$4,280M, +14% y/y

Adjusted EPS at $5 96 +21% y/y• Adjusted EPS at ~$5.96, +21% y/y

• Improved operating margins ~30 bps

• Repurchased over $2 7 billion in shares• Repurchased over $2.7 billion in shares

• Raised $1.5 billion in long-term notes

5

Notes: All 2013 financial figures are unaudited.


Expanding Our Leadership in Hematology

Capitalizing on strength in Hematology

REVLIMID® d t t d PFS d OS b fit i th

Capitalizing on strength in Hematology

• REVLIMID® demonstrated PFS and OS benefit in the Ph III MM-020 trial (NDMM)

• REVLIMID® approved in EU for del 5q MDS, in U.S. for MCL and in China for RRMMMCL and in China for RRMM

• POMALYST®/IMNOVID® RRMM approved in U.S. and EU

• Advanced clinical programs in myeloma, lymphoma, leukemia, anemia and MDS

• Strengthened hematology portfolio through collaborations

6

R E V L I M I D ® :

Execution and New Indications Accelerate Growth31 2 433

Key Growth DriversKey Growth DriversSales ($M) $1 136

1 2 43

• Increased duration of therapy and market share growth in RRMM

• Expansion into NDMM

Sales ($M)

$1,090

$1,136

p– U.S. and EU regulatory submissions

on-track for Q1:14

• New Indications for MDS, NHL & CLLPh III MDS 005 non del 5q MDS data

$1,052

– Ph III MDS-005 non-del 5q MDS data expected in Q4:14

– Ph III REMARC trial in DLBCL enrollment completion expected in Q1:14

– Ph III RELEVANCE trial in follicular NHL

$1,003

enrollment ahead of schedule– Ph III CONTINUUM trial in CLL enrolling

7

Notes: Sales Unaudited.

Q1 Q2 Q3 Q4

R E V L I M I D ® :

Execution and New Indications Accelerate Growth11

Key Growth DriversKey Growth DriversSales ($B)

9%CAGR

• Increased duration of therapy and market share growth in RRMM

• Expansion into NDMM

Sales ($B)

$7.013%CAGRCAGR

p– U.S. and EU regulatory submissions

on-track for Q1:14

• New Indications for MDS, NHL & CLLPh III MDS 005 non del 5q MDS data

$4.3

$6.0CAGR

– Ph III MDS-005 non-del 5q MDS data expected in Q4:14

– Ph III REMARC trial in DLBCL enrollment completion expected in Q1:14

– Ph III RELEVANCE trial in follicular NHL enrollment ahead of schedule

– Ph III CONTINUUM trial in CLL enrolling

2013* 2015E 2017E

8

Notes: *Unaudited.

P O M A L Y S T ® / I M N O V I D ® :

Establishing a New Standard in RRMM4

Key Growth DriversKey Growth Drivers

4

Sales ($M)

$121

• Global launch is ongoing– U.S. approval on February 8, 2013– EU approval on August 5, 2013;

reimbursement in key markets

Sales ($M)

$66

$90

reimbursement in key markets expected throughout 2014

– Additional global approvals expected

• Increase duration of therapy

$29

$66– Potential strategies to move into 2nd line multiple myeloma

• Combination strategies with:Proteasome inhibitors $29– Proteasome inhibitors

– Monoclonal antibodies– HDAC inhibitors

9

Q1 Q2 Q3 Q4


P O M A L Y S T ® / I M N O V I D ® :

Establishing a New Standard in RRMM

Key Growth DriversKey Growth DriversSales ($B)

• Global launch is ongoing– U.S. approval on February 8, 2013– EU approval on August 5, 2013;

reimbursement in key markets

Sales ($B)

$1.5

reimbursement in key markets expected throughout 2014


• Increase duration of therapy $1.0

35%CAGR 49%CAGR

– Potential strategies to move into 2nd line multiple myeloma

• Combination strategies with:Proteasome inhibitors $0 3– Proteasome inhibitors

– Monoclonal antibodies– HDAC inhibitors

$0.3

2013* 2015E 2017E

10

Notes: *Unaudited.


Broadening Our Footprint in Oncology

Building new franchises in OncologyBuilding new franchises in Oncology

• ABRAXANE® pancreatic cancer approved in U.S. and EU

• ABRAXANE® NSCLC/gastric cancer approved in Japan

• Advanced Ph III ABRAXANE® programs in triple negative• Advanced Ph III ABRAXANE® programs in triple negative breast cancer, adjuvant PanC and NSCLC maintenance

• Initiated Ph II programs with CC-486 (epigenetic priming), CC-223 (TORKi) and VTX-2337(TLR8)CC 223 (TORKi) and VTX 2337(TLR8)

• Broadened oncology portfolio through collaborations

11

A B R A X A N E ® :

New Indications for NSCLC & PanC Accelerate Growth4

Key Growth DriversKey Growth DriversSales ($M)

4

$155$170

$20290%90%

• Establishing a new standard of care in metastatic pancreatic cancer

– U.S. approval on September 6, 2013EU approval on December 23 2013

Sales ($M)

$123

$155

60%60%

– EU approval on December 23, 2013– Additional global approvals expected

• Expanding into new patient segments in core indications

41%41%

g– Ph III trials for triple-negative mBC,

adjuvant PanC, and NSCLC maintenance

• Expanding into new cancers in 2014

% ∆ Y/Y

18%18% Sales• Expanding into new cancers in 2014

– Ph II trials for colorectal and ovarian– Ph I/II combo with anti-PDL-1/PD-1

12

Q1 Q2 Q3 Q4


Key Growth Drivers

A B R A X A N E ® :

New Indications for NSCLC & PanC Sustain Growth

$0.65

$1.5-$2.0

2013* 2015E 2017E

• Establishing a new standard of care

in metastatic pancreatic cancer

– U.S. approval on September 6, 2013

– EU approval on December 23, 2013


• Expanding into new patient

segments in core indications

– Ph III trials for triple-negative mBC,

adjuvant PanC, and NSCLC

maintenance

• Expanding into new cancers in 2014

– Ph II trials for colorectal and ovarian

– Ph I/II combo with anti-PDL-1/PD-1

Notes: *Unaudited; #CAGR calculated using 2013 and 2017 midpoint.

Sales ($B)

4

28% CAGR#


Preparing the Global Launch of OTEZLA® (apremilast)

Building new franchises in I & IBuilding new franchises in I & I

• Submitted OTEZLA® in the U.S./EU for PsA and psoriasis

• Strengthened OTEZLA® profile with longer-term data in PsA and psoriasisp

• Pivotal trials featured at major medical meetings

• Key leadership in place to drive launch

I iti t d Ph II OTEZLA® f C h ’ di• Initiated Ph II OTEZLA® programs for Crohn’s disease, ulcerative colitis, and atopic dermatitis

14

O T E Z L A ® :

Ready to Launch in PsA and Psoriasis in 2014

Key Growth DriversKey Growth Drivers Large Underserved

PsoriaticA th iti

Patient Populations

~1 0MPsA

• Approvals expected in 2014– U.S.: PsA in Q1; psoriasis in Q3– EU: PsA and psoriasis in Q1:15

Arthritis 1.0M

P i i

• Launch preparedness– Brand strategy and positioning defined– Commercial team in place– Patient/physician support service built

~2.5MPsoriasis (moderate to severe)

Patient/physician support service built

• Optimize OTEZLA® opportunity– Ph III trial in ankylosing spondylitis – Ph II trials in Crohn’s disease, ulcerative

~2.5MAnkylosingSpondylitis

colitis and atopic dermatitis initiating– QD formulation

15

O T E Z L A ® :

Profile Strengthens with Longer Treatment Duration2 3

52-Week PsA Data52-Week PsA Data

2 3

32-Week Psoriasis Data 32-Week Psoriasis Data

60

70

80

espo

nse

(%)

in P

AS

I (%

)

60

70

* *

Data as observed

40

50

60

an A

CR

20

Re

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Bas

elin

e

30

40

50

*

*

10

20

30

nts

Ach

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ng a

mpr

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ent f

r10

20

30

*

0

10

week 0

week 16

week 24

week 40

week 52

PALACE 1 PALACE 2

Pat

ien

Mea

n Im

0Baseline 4 6 8 10 12 14 16 20 24 28 32

Weeks OTEZLAPlacebo

16

PALACE 3 PALACE 4 *P<0.0001 vs. placebo (LOCF)PlaceboPbo/OTEZLA

O T E Z L A ® :

OTEZLA® Use Expected Before Biologics in PsA

Question: Of your next 100 patients on apremilast, what percent of patients would you distribute to each of the following points in the therapy sequence?

~66% of patients would be pre-biologic

12% 54% 34%12% 54% 34%

Before 1st DMARD DMARD Experienced After ≥ 1 biologicBefore 1st DMARD DMARD Experienced After ≥ 1 biologic

17

Source: National Analysts, n=150 U.S. rheumatologists, Review of Apremilast PALACE 1-3 24 week Target Product Profile Q3 2013

O T E Z L A ® :

Unique Opportunity in Ankylosing Spondylitis

Large Underserved Another Large OpportunityAnother Large Opportunity

PsoriaticA th iti

Patient Populations

~1 0MPsA

Arthritis 1.0M

P i i~2.5M

Psoriasis (moderate to severe)

~2.5MAnkylosingSpondylitis

18

Data from ~500 patient Ph III trial expected in H1 Data from ~500 patient Ph III trial expected in H1


Sustaining Growth through Innovation

Sustaining innovation and long term growth

Ad d t d i t li i l t i l

Sustaining innovation and long-term growth

• Advanced partnered programs into clinical trials

• Accelerated Ph II trials to critical decision points

• Initiated broad program with novel novel combinations• Initiated broad program with novel-novel combinations

• Named new development candidates and advanced the early stage pipeline

• Initiated new and broadened existing strategic collaborations

19

Complementing Our Internal Strengths with Selected External Partnerships

Novel IMiDs® /CRBN & OtherUbiquitin Ligase

New Targets, EpigeneticPriming &

CGDF Family

PKC

Payload Delivery,Next Gen

Complementary Approaches to Ubiquitin Ligase

TargetsConvergencewith Metabolic

Targets

+PDE4 Complementation

+PKC

PKC,BTKi, TYK2,

Novel Targets

JNK1, New Targets,

Novel phenotypic screens

Next GenEnhanced Activities

Immuno‐therapy,

Breaking Tumor Tolerance

Unique Validation / Testing Capabilitiesfrom

Tumor Tissue

Pathway ConvergentMechanisms,

Synthetic LethalCombinations

RationalRational

CancerCancerStem Cells/Stem Cells/ResistanceResistance

ImmunoImmuno‐‐therapytherapy

EpigeneticsEpigeneticsNextNext

GenerationGenerationBiologicsBiologics

ProteinProteinHomeostasisHomeostasis

Apremilast+Apremilast+

NovelNovelTargets FitTargets Fitfor Purposefor Purpose

FibrosisFibrosis

Combinations

20

RationalRationalCombinationsCombinations

Apremilast+Apremilast+CombinationsCombinations

PLATFORMS

Advancing Novel Programs into Phase I

21

DC IND

Advancing Novel Programs into Phase I

Key Phase I Studies Planned/Underway:MOR 202 in RRMM and AML

ACY 1215 in RRMMACY-1215 in RRMMEPZ-5676 in MLL-r

AG-221 in IDH1m AMLPDA-002 in PAD

Demcizumab in Solid TumorsCC-90001 in FibrosisCC 90001 in Fibrosis

Novel-Novel DLBCL Combinations

DC IND

22

≥≥3 3 new INDs new INDs targeted per targeted per yearyear

Expanding Phase II Program with New Entities

Over 100 Phase II Trials Planned/Underway:CC-486 Priming in Solid Tumors

CC 122 in Hematologic MalignanciesCC-122 in Hematologic MalignanciesCC-292 in CLL, NHL and RA

Sotatercept (ACE-011) in MDS, Anemia, CKDACE-536 in MDS, Anemia

CC-220 in SLE, Scleroderma and SarcoidosisPDA-001 in Crohn’s DiseasePDA 001 in Crohn s DiseaseVTX-2337 in Solid Tumors

DC IND

23

Significant data flow expected in 2014/2015Significant data flow expected in 2014/2015

Broadening Phase III Program

Over 30 Phase III Trials Planned/Underway:OTEZLA® in Ankylosing Spondylitis and Behçets

REVLIMID® in NDMM, NHL and CLLCC 486 in MDS and AMLCC-486 in MDS and AML

ABRAXANE® in TNBC, Adjuvant PanC, NSCLCSotatercept / ACE-536 in β-Thalassemia

DC IND

24

Potential upside to Potential upside to 2017 financial targets2017 financial targets

Our Deep Clinical and Development Pipeline

21 Programs in Clinical Developmentg p

100+ Celgene-sponsored Clinical Trials

28 000 E ll d P ti t~28,000 Enrolled Patients

Over 50 Indications

DC IND

25

Powerful Business Model, Driving Sustainable Growth

Our Growth OutlookOur Growth Outlook

26

Raising Product Sales Targets in 2015 and 2017

Product Sales ($B)

+$1.5B+$1.5B

$13-$14Now

$12++$0.5B+$0.5B

$6 4

$8.5-$9.5Now

$8-$9

$12++$0.4B+$0.4B

$6.4

Before

Before$6+

Before

Now

2013* 2015E 2017E

27

Notes: *Unaudited.

Building on Strong Momentum in Core Franchise

Before Now Change

2017 Sales

Before Now Change

$6B $7B +$1B

$ $ $

11

$1B $1.5B +$0.5B

Total Hematology $8B-9B $9.5B-$10B +$1.5B

22

$1.5B-$2B $1.5B-$2B –

$1.5B-$2B $1.5B-$2B –

33

44

Total $12B+ $13B-$14B +$1.5B

28

Accelerating Growth Outlook Through 2017

Product Sales($B)

EPS2

($)

19%CAGR1 25%

CAGR

$13-$14Now

$12+

~$15Now

$13 14

21%CAGR1 26%

CAGR

$8.5-$9.5Now

$8-$9

$12

$9-$9.50Now

$13-14

$6.4$5.96

o$8-$9

$6+Now

$5.50-$5 60

Now

$5.60

29

Notes: 1) CAGR calculated using 2013 and 2017 midpoint. 2) Adjusted. 3) Unaudited.

20133 2015E 2017E 20133 2015E 2017E

2014 Financial Guidance

2014 Financial Guidance2014 Financial Guidance2014 Financial Guidance2014 Financial Guidance

Total product sales: $7.3 to $7.4 Billion, +16% Y/Y

Total REVLIMID sales: $4.9 to $5.0 Billion, +16% Y/Y

Adjusted EPS: $7.00 to $7.20, +19% Y/Y

Operating margin1: ~50%, +160 bps

30

Notes: 1) Adjusted.

T H E C E L G E N E S T O R Y

Powerful Business Model, Driving Sustainable Growth

Leveraging Strong Growth Sustainable Trajectory g gPowerful Model

gto 2017

j yBeyond 2017

Leveraging model 4 blockbuster 21 programs– all metrics

improving

More diversifiedl i k

products by 2017

Trajectory increased to 26% CAGR

>50 indications

100+ clinical trials– lower risk

5-10years

26%CAGR

Adjusted EPS

2013 2015E 2017E

years

31

2013 2015E 2017E

32nd Annual J.P. Morgan Healthcare Conference

J 13 2014January 13, 2014

Key Milestones – 2014

Business Milestone Expected Timing

• Submit REVLIMID® for NDMM in the U S and EU Q1• Submit REVLIMID® for NDMM in the U.S. and EU Q1

• Ph III VIDAZA® data in AML (AZA-AML-001) H1

• Initial Ph I data from AZA-ST-001 (CC-486 priming) H1

• Ph III REVLIMID® data in non-del 5q MDS H2Hematology& Oncology

Ph III REVLIMID data in non del 5q MDS H2

• Ph I MOR202 data in RRMM H2

• Ph II Sotatercept (ACE-011) data in MDS H2

• Ph II ACE-536 data in MDS and β-thalassemia H2β

• Initial Ph I/II CC-292+REVLIMID® in CLL H2

• Ph Ib demcizumab combination data in PanC and NSCLC 2014

• OTEZLA® approval in the US for PsA Q1

I & I

• Ph III OTEZLA® data in ankylosing spondylitis H1

• OTEZLA® approval in the US for psoriasis Q3

• OTEZLA® CHMP opinion for PsA and psoriasis Q4

• Ph II Sotatercept (ACE-011) data in renal anemia 2014

33

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32nd annual j.p. morgan healthcare conference...2013* 2015e 2017e • establishing a new standard of...

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