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UBS Global Healthcare Conference M 19 2014 May 19, 2014

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Page 1: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

UBS Global Healthcare Conference

M 19 2014May 19, 2014

Page 2: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

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.

Page 3: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

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

Page 4: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

A Leading Global Biopharmaceutical Company

Global, FullyIntegrated

Portfolio ofLeading Products

Unique R&DCapability

• Operations in >50 countries

• Sales in >70 countries

• Manufacturing facilities

• Expertise in hematology, oncology, and immunology

• Diverse technology • Manufacturing facilities in US and EU

• Key research facilities in NJ, CA, MA & Spain

• ~5 000 employees

platforms

• Rich pipeline– 30 programs in

preclinical development– 22 treatments in• ~5,000 employees

globally22 treatments in clinical trials

– 30 pivotal / phase III programs underway

4

Page 5: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Proven Business Model – Moving into its Sweet Spot

Proven Model… Entering its Sweet Spot

1. Unmetneeds

2. Differentiatedproducts Sustainable top and bottom

line growthline growth

P&L operating leverage

Growing cash flowg

More diversified drivers –lower risk profile

3. Leverageinfrastructure

4. Leadingperformance

Growth primarily organic, highly accretive new products

5

Page 6: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Strong, Consistent Revenue and Earnings Growth

Net Product Sales1

($B)EPS3

($)

$5.96$6.4

($B) ($)

25%

$3.79

$4.91

$4.7

$5.4~25%CAGR2 ~31%

CAGR2

$2.08

$2.79$2.6

$3.5

6

2009 2010 2011 2012 2013

Notes: 1) Net Product Sales adjusted for 2008-2011, 2) CAGR calculated using 2008 to 2013. 3) Adjusted

2009 2010 2011 2012 2013

Page 7: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Our Business Model Is Proven and Scalable

50.5%50.5%

24 2%24 2%R&DR&D 24.2%24.2%

20.7%20.7%SG&ASG&A

2008 2009 2010 2011 2012 2013 YTD 2014

4.7%4.7%COGSCOGS

7

Notes: 1) Adjusted.

2008 2009 2010 2011 2012 2013 YTD 2014

Page 8: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Powerful Drivers. Delivering Sustainable Growth.

Our Growth Outlook to 2017

Driving Sustainable Growth

8

Page 9: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Strong Momentum in Core Franchise

2017 Sales

$7.0B

$

11

$1.5B

Total Hematology $9.5B-$10B

22

$1.5B-$2B

$1.5B-$2B

33

44

Total $13B-$14B

9

Page 10: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

R E V L I M I D ® :

Execution and New Indications Accelerate Growth11 2 3 41Key Growth DriversKey Growth Drivers

• Increased duration of therapy and market share growth in RRMM Sales ($B)

1 2 3 4

9%CAGR

market share growth in RRMM

• NDMM expansion on-track– EU dossier submitted in February 2014– US submitted in April 2014

Sales ($B)

$7.013%CAGRCAGR

• Growth drivers advancing – MCL-002 and MDS-005 data in H2– Results of phase III combination studies

in multiple myeloma by Q4 $4.3

CAGR

p y y– REMARC phase III in DLBCL first-line

maintenance completed enrollment – RELEVANCE phase III in FL expected to

complete enrollment by year-end– CLL-002 (CONTINUUM) phase III

maintenance trial continues to enroll

2013 2015E 2017E

10

Page 11: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

P O M A L Y S T ® / I M N O V I D ® :

Establishing a New Standard in RRMM1 2 3 4

Key Growth DriversKey Growth DriversSales ($B)

1 2 3 4

• 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

– Additional global approvals expected

• Increase duration of therapy

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

11

Page 12: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

A B R A X A N E ® :

New Indications for NSCLC & PanC Sustain Growth41 2 3 4

Key Growth DriversKey Growth DriversSales ($B)

41 2 3 4

$1.5-$2.0

• Establishing a new standard of care in metastatic pancreatic cancer

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

Sales ($B)

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

• Expanding into new patient segments in core indications

28%CAGR*

$0.65

g– Ph III trials for triple-negative mBC,

adjuvant PanC, and NSCLC maintenance

• Expanding into new cancers in 2014• Expanding into new cancers in 2014– Ph II trials for colorectal and ovarian– Ph I/II combo with anti-PDL-1/PD-1

12

2013 2015E 2017E

Notes: *CAGR calculated using 2017 midpoint.

Page 13: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

O T E Z L A ® :

Ready to Launch in PsA and Psoriasis in 20141 2 3 4

Key Growth DriversKey Growth Drivers Large Underserved

1 2 3 4

PsoriaticA th iti

Patient Populations

~1 0MPsA

• Approvals expected in 2014– U.S.: PsA approved in March; psoriasis

in Q3E– EU: PsA and psoriasis in Q1:15E

Arthritis 1.0M

P i i

• U.S. launch progressing– Reps in offices within 3 days of approval– Top targets visited

~2.5MPsoriasis (moderate to severe)

– First formulary approvals

• Optimize OTEZLA® opportunity– Ph III trial in ankylosing spondylitis – Ph II trials in IBD and atopic dermatitis

~2.5MAnkylosingSpondylitis

– Ph II trials in IBD and atopic dermatitis initiating

– QD formulation

13

Page 14: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

O T E Z L A ® :

Unique Opportunity in Ankylosing Spondylitis1 2 3 4

Large Underserved Another Large OpportunityAnother Large Opportunity

1 2 3 4

PsoriaticA th iti

Patient Populations

~1 0MPsA

Arthritis 1.0M

P i i~2.5M

Psoriasis (moderate to severe)

~2.5MAnkylosingSpondylitis

14

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

Page 15: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Late Stage Product Acquisition: GED-0301First-in-Class, Oral Antisense Drug Targeting Smad7 mRNA

• Fits with mission of bringing innovative treatments to patients with significant unmet needssignificant unmet needs

• Potential transformational technology in Crohn’s disease• Novel mechanism of action, locally active in the gut, minimal systemic y g y

absorption• Demonstrated striking clinical activity in a phase II trial and was well

toleratedtolerated• Phase III registration program by year-end 2014• Deal terms:

• $710M upfront payment• Potential $815M aggregate regulatory and development milestones for

multiple indicationsP t ti l $1 050M t ti d l il t if l t• Potential $1,050M aggregate tiered sales milestones if annual net sales reach $4,000M

15

Page 16: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Powerful Drivers. Delivering Sustainable Growth.

Our Growth Outlook to 2017

Driving Sustainable Growth

16

Page 17: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Complementing Our Internal Strengths with Selected External Partnerships

Novel IMiDs® /CRBN & OtherUbiquitin Ligase

New Targets, Epigenetic

Reprogramming& C

GDF Family   PKC,BTKi

Payload Delivery,Next Gen

Novel and Complementary      Approaches to U iUbiquitin Ligase

Targets& Convergence with Metabolic 

Targets

+PDE4 Complementation 

+PKC

BTKi, TYK2,

Novel Targets , Serine

Hydrolases 

JNK1, New Targets,

Novel   phenotypic  screens  

Next GenEnhanced Activities

Approaches to  Immuno‐therapy, 

Breaking Tumor   Tolerance

Unique    Validation /   Testing Capabilities

from Breaking Tumor 

Tolerance

Pathway ConvergentMechanisms,

Synthetic LethalCombinations

CancerCancerStem Cells/Stem Cells/ResistanceResistance

ImmunoImmuno‐‐therapytherapy

EpigeneticsEpigeneticsNextNext

GenerationGenerationBiologicsBiologics

ProteinProteinHomeostasisHomeostasis

OTEZLA+OTEZLA+

NovelNovelTargets FitTargets Fitfor Purposefor Purpose

FibrosisFibrosis

Combinations

CancerCancer

17

OTEZLA+OTEZLA+CombinationsCombinations

PLATFORMS

Stem Cells/Stem Cells/ResistanceResistance

Page 18: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

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 IDH2m AMLPDA-002 in PAD

Demcizumab in Solid TumorsCC-90001 in FibrosisCC 90001 in Fibrosis

Novel-Novel DLBCL Combinations

DC IND

18

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

Page 19: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

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

19

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

Page 20: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Broadening Phase III Program

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

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

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

GED-0301 in Crohn’s diseaseGED 0301 in Crohn s disease

DC IND

20

Potential upside to Potential upside to 2017 financial targets2017 financial targets

Page 21: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Our Deep Clinical and Development Pipeline

22 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

21

Page 22: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Accelerating Growth Outlook Through 2017

Product Sales($B)

EPS2

($)

$13-$1421%CAGR1

~$1526%CAGR

$8.5-$9.5$9-$9.50

$6.4$5.96

22

Notes: 1) CAGR calculated using 2017 midpoint. 2) Adjusted.

2013 2015E 2017E 2013 2015E 2017E

Page 23: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

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 22 programs– all metrics

improving

More diversifiedl i k

products by 2017

Adjusted EPS expected to grow at 26% CAGR

>50 indications

100+ clinical trials– lower risk 26% CAGR

5-10years

26%CAGR

Adjusted EPS

2013 2015E 2017E

years

23

2013 2015E 2017E

Page 24: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

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) Q2

• Initial Ph I data from AZA-ST-001 (CC-486 priming) Q2

• 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 U.S. for PsA Q1

I & I

• Ph III OTEZLA® data in ankylosing spondylitis Q2

• OTEZLA® approval in the U.S. for psoriasis Q3

• OTEZLA® CHMP opinion for PsA and psoriasis Q4

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

24

Page 25: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

UBS Global Healthcare Conference

M 19 2014May 19, 2014

Page 26: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Reconciliation Tables

2009

2008

776.7

(1,53

3.7)

$

(12.7)

(17.0)

-

-

-

-

4.4

2.5

0.4

24.6

8.3

7.0

-

-

(0.6)

(0.8)

64.8

44.0

34

.5

45

.0

-

-

-

-

-

303.1

74.6

60.1

-

-

-

-

83.4

104.0

-

-

-

1,740

.0

-

-

1.4

3.6

-

-

-

-

-

-

(63.9)

(63.6)

97

1.3

71

8.8$

2.11

1.62

$

2.0

8

1.5

6$

2010

2

.188

0.5$

$

.4)(8.

2)

.3)(15

.9)

.7)(0.

9)

.86.8

.334

.7

.99.8

.29.3

(0.3)

.782

.1

.512

1.2

.77.3

.0

-

.793

.9

.115

.1

.8-

.220

3.2

.5)9.7

.137

.5

-

-

.6

1.3

.0

(1.4)

.9)

-

.7)(0.

3)

.3)(17

4.9)

.9

1,310

.5$

$

852.8

3$

$

792.7

9$

$

me hs En

ded D

ecem

ber 3

1,20

1220

11

1,456

.2$

1,3

18.

$

-

(5.

-

(21

.

-

(1.

12.4

9.

-

90.

(1.6)

9.

-

13

.

-

-

102.4

104.

189.5

128.

-

8.

122.5

118.

-

-

116.2

102.

-

15.

-

9.

194.5

289.

166.4

(147.

2.6

5.

-

-

-

-

-

0.

-

2 .

-

(2.

-

(0.

(198.6

)

(29

3.

2,1

62.5

$

1,752

.$

5.02

$

3.8

$

4.91

$

3.7

$

ratio

n and

Subs

idiar

iesAA

P to A

djuste

d Net

Inco

s, exce

pt per

shar

e data

) Twelv

e Mon

th20

13 1,449

.9$

$

(1)-

(1)-

(2)-

18.5

(3)-

(2)-

(2)-

(4)-

144.7

(5)

575.8

(2)

-

(6)

-

(7)

-

162.6

(2)

-

(8)

-

262.8

n(9)

171.1

(9)

-

(10)

-

80.0

(4)-

(2)-

-

(2)-

(12)

(302.3

)

2,563

.1$

$

Adjus

ted6.1

9$

$5.9

6$

$

Celge

ne C

orpo

Reco

ncilia

tion o

f GA

(In m

illion

s

ble to

Celg

ene -

GAA

P

stmen

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ucts

exite

d it to

be ex

ited:

agree

ments

and o

ther r

even

ue:

n-core

reve

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sold (

exclu

ding a

mortiz

ation

ntang

ible as

sets):

d com

pensa

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xpen

se d P

harm

ion in

vento

ry ste

p-up

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it to

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y roy

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deve

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ayme

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26

Net in

come

attrib

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adjus

Net

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ct sa

S

ales o

f pro

Pharm

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Ab

raxis

Colla

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Cost

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Dilut

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Page 27: UBS Global Healthcare Conference · A Leading Global Biopharmaceutical Company Global, Fully Integrated Portfolio of Leading Products Unique R&D Capability • Operations in >50 countries

Reconciliation Tables

Celgene Corporation and SubsidiariesR ili ti f GAAP t Adj t d N t I

Explanation of adjustments:(1) Exclude sales related to non-core former Pharmion Corp., or Pharmion, and Abraxis BioScience Inc., or Abraxis products to be divested.(2) Exclude the estimated impact of activities arising from the acquisition of Abraxis that are not related to core nab technology and

were divested in 2011, including other miscellaneous revenues, cost of goods sold (excluding amortization of acquired intangible assets), operating

Reconciliation of GAAP to Adjusted Net Income

expenses and other costs related to such activities. Exclude the net (benefit) cost of activities arising from the acquisition of Pharmion that are planned to be exited.

(3) Exclude acquisition-related inventory step-up adjustments to fair value which were expensed for Abraxis in 2011 and 2010 and Pharmion in 2009 and 2008.(4) Exclude the Company's share of EntreMed, Inc. THALOMID royalties and equity losses. (5) Exclude upfront payments for research and development collaboration arrangements and purchases of intellectual property for unapproved products.(6) Exclude in-process research and development, or IPR&D, impairments.(7) Exclude the purchase of VIDAZA royalty obligations related to unapproved forms.(8) Exclude pricing settlement with the Patented Medicine Prices Review Board of Canada related to sales of THALOMID.(9) Exclude acquisition related charges and restructuring, including changes in the fair value of contingent consideration, related to the acquisitions of

Gloucester, Abraxis and Avila.(10) Exclude the IPR&D write-off related to the acquisition of Pharmion Corp. in 2008.(11) Exclude impairment of royalty receivable asset that was received in 2011 as partial consideration in the sale of the non-core assets obtained by Celgene in the

acquisition of Abraxis.(12) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments,

including one-time effects of changes in tax law, acquisition related matters, adjustments to the amount of unrecognized tax benefits and deferred taxes on unremitted foreign earnings.

27