cowen 35th annual health care conference -...

Cowen 35th Annual Health Care ConferenceMarch 4, 2015

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 unaudited financial information prepared in accordance with U.S. GAAP, thispresentation also contains adjusted financial measures that we believe provide investors andmanagement with supplemental information relating to operating performance and trends thatfacilitate comparisons between periods and with respect to projected information. These adjustedmeasures are non-GAAP and should be considered in addition to but not as a substitute for themeasures are non GAAP and should be considered in addition to, but not as a substitute for, theinformation prepared 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

2

of these adjusted financial measures to the most comparable GAAP measures, may be found onour website at www.Celgene.com in the “Investor Relations” section.

Our Mission and Vision

Celgene is building a preeminent global biopharmaceutical company focused on the discovery development andcompany focused on the discovery, development and

commercialization of innovative therapies for unmet medical needs in cancer and immune-inflammatory diseases

3

needs in cancer and immune inflammatory diseases

A Leading Global Biopharmaceutical Company

Unique R&DCapability

Global, FullyIntegrated

Portfolio of Leading Products

• Expertise in hematology, oncology, and immunology

• Operations in >60 countries• Sales in >70 countries gy, gy

• Diverse technology platforms• Rich pipeline

– 30 programs in preclinical development

• Sales in >70 countries• Manufacturing facilities

in U.S. and EU• Key research facilities in NJ,

CA MA and Spain– 25 treatments in

clinical trials– 15 pivotal / phase III

programs underway

CA, MA and Spain• ~6,500 employees globally

4

Strong Financial Track Record Delivering High Growth

>2020 Financial Momentum Creates a Strong Foundation

2018-2020Creating the

Future

St G th

Adjusted EPSTotal Revenue

2014-2017

On Track to Meet

Strong Growth Expected to 2020

Or Exceed 2017 Financial Targets

>2020

2010 2011 2012 2013 2014

Guidance Actual

2010 2011 2012 2013* 2014

Guidance Actual

5

* Guidance provided for net product sales

Label Expansions & New Products Expected to Accelerate Growth

Label expansions& new products

l t th

18%

accelerate growth

+3% points

CAGRStrong growth

from existing products

2014 2017E 2020E

6

Existing Products Label Expansions; New Products

Key Drivers to 2020

Capitalizing on strength in HematologyCapitalizing on strength in Hematology

Expanding the Oncology franchise Expanding the Oncology franchise

Building an Immunology & Inflammation franchiseBuilding an Immunology & Inflammation franchise

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

7

Label Expansions & New Product Introductions Expected to Accelerate Growth Through 2020

Expected Growth OpportunitiesExpected Growth Opportunities Sales ($B)

12%14%

Growth from Existing Portfolio:• REVLIMID® approvals for NDMM in U.S.

and Europe• Duration and market share gains for

>$14.8

$13 012%CAGR 14%CAGR

Duration and market share gains for REVLIMID® and POMALYST®/IMNOVID®

New Indications & Opportunities:• REVLIMID® in novel combos in myeloma $6 6

$13.0

y• REVLIMID® for NHL

New Product Introductions:• CC-486 (oral azacitidine) in MDS and AML

$6.6

2014 2017E 2020E

• Sotatercept or luspatercept in beta-thalassemia

• AG-221 in IDH2 mutant AML

8

Existing Products

Label Expansions; New Products

Label Expansions & New Product Introductions Expected to Accelerate Growth Through 2020

Expected Growth OpportunitiesExpected Growth Opportunities Sales ($B)Hematology Upside Potential Through 2020Hematology Upside Potential Through 2020

12%14%

Growth from Existing Portfolio• REVLIMID® approvals for NDMM in U.S.

and Europe• Duration and market share gains for

>$14.8

$13 0

• Full impact of REVLIMID® and POMALYST®/IMNOVID® treatment duration

• REVLIMID® for non-del 5q in Europe12%CAGR 14%CAGR

Duration and market share gains for REVLIMID® and POMALYST®

New Indications & Opportunities:• REVLIMID® in novel combos in myeloma $6 6

$13.0• REVLIMID® for maintenance in CLL

• Greater adoption of REVLIMID® in R/R follicular NHL

• Approval for sotatercept or luspatercept in MDSy• REVLIMID® for NHL

New Product Introductions:• CC-486 (oral azacitidine) in MDS and AML

$6.6pp o a o so a e cep o uspa e cep S

• Earlier than expected approval for AG-221 in R/R AML (IDH2 mutations)

• Approval for AG-120 in R/R AML (IDH1 mutations)

2014 2017E 2020E

• Sotatercept or Luspatercept in beta-thalassemia

• AG-221 (IDH2 mutant AML)

• Approval for AG-120 in R/R AML (IDH1 mutations)

• Approval for CC-122 in DLBCL, CLL or MM

9

Existing Products


Key Drivers to 2020





10

ABRAXANE® Label Expansion Opportunities Accelerate Momentum Through 2020

Expected Growth OpportunitiesExpected Growth Opportunities>$2 2

Sales ($B)>$2.2Growth from Existing Portfolio:

• Market share and geographic expansion of ABRAXANE® in NSCLC and metastatic pancreatic cancer 14%

CAGR $1.917%CAGRpancreatic cancer

New Indications & Opportunities:• ABRAXANE® late stage trials in:

• Adjuvant pancreatic cancer

CAGR $1.9CAGR

$0.85Adjuvant pancreatic cancer

• Triple negative breast cancer

• Neoadjuvant breast cancer

• Additional segments of NSCLC

2014 2017E 2020E

g

11

ABRAXANE® Label Expansions; New Opportunities

ABRAXANE® Label Expansion Opportunities Accelerate Momentum Through 2020

Expected Growth OpportunitiesExpected Growth Opportunities>$2 2

Sales ($B)Oncology Upside Potential Through 2020Oncology Upside Potential Through 2020>$2.2

Growth from Existing Portfolio• Market share and geographic expansion of

ABRAXANE® in NSCLC and metastatic pancreatic cancer

14%CAGR $1.917%CAGR

• ABRAXANE® in anti-PD1 / anti-PDL1 combinationspancreatic cancer

New Indications & Opportunities:• ABRAXANE® late stage trials in:

• Adjuvant pancreatic cancer

CAGR $1.9CAGR

• Demcizumab approval in non-small cell lung and pancreatic cancers

$0.85• Adjuvant pancreatic cancer

• Triple negative breast cancer

• Neoadjuvant breast cancer

Additional segments of NSCLC

• VTX-2337 approval in ovarian and SCCHN

2014 2017E 2020E

• Additional segments of NSCLC• CC-486 approval in solid tumors

12

ABRAXANE® Label Expansions; New Opportunities

Key Drivers to 2020





13

New Products Expected to Accelerate Growth in I&I

Expected Growth OpportunitiesExpected Growth Opportunities Sales ($B)

>$3.0Growth from Existing Portfolio:• Continued launch acceleration of

OTEZLA® in the U.S. and Europe for psoriasis and psoriatic arthritis

$2.378%CAGR 87%CAGR

• Geographic expansion

New Indications & Opportunities:• OTEZLA® expansion in Behçets, atopic p ç p

dermatitis and ulcerative colitis

New Product Introductions:• GED-0301 in Crohn’s disease

2014 2017E 2020E

$0.07• CC-220 in lupus• Sotatercept in renal anemia

14

Existing Products


New Products Expected to Accelerate Growth in I&I

Expected Growth OpportunitiesExpected Growth Opportunities Sales ($B)I&I Upside Potential Through 2020I&I Upside Potential Through 2020

>$3.0Growth from Existing Portfolio:• Continued launch acceleration of

OTEZLA® in the U.S. and Europe for psoriasis and psoriatic arthritis• Earlier than expected GED-0301 approval in Crohn’s disease

GED 0301 l i l ti liti

$2.378%CAGR 87%CAGR

• Geographic expansion

New Indications & Opportunities:• OTEZLA® expansion in Behçets, atopic

• GED-0301 approval in ulcerative colitis

• Earlier than expected approval of sotatercept in renal anemia and CC-220 in lupusp ç p

dermatitis and ulcerative colitis

New Product Introductions:• GED-0301 (smad 7 anti-sense) in Crohn’s

disease

• OTEZLA® in AS and RA

• Accelerated OTEZLA® development in

2014 2017E 2020E

$0.07

disease• CC-220 (cereblon modulator) in lupus• Sotatercept (ActR2B fusion protein) in

renal anemia

• Accelerated OTEZLA development in atopic dermatitis and ulcerative colitis

15

Existing Products


Key Drivers to 2020





16

Harnessing the Power of Our Novel Distributed Research Model

Novel IMiDs® /CRBN & OtherUbiquitin Ligase

Targets

New Targets, EpigeneticPriming

& Convergence with Metabolic Targets

GDF Family PKC,BTKi, TYK2,

Novel Targets

JNK1, New Targets,

Novel phenotypic

Payload Delivery,Next GenEnhanced Activities

Novel and Complementary Approaches to Immuno‐therapy,

Breaking Tumor Tolerance

Unique Validation / Testing Capabilities

from Breaking Pathway

CancerCancerStem Cells/Stem Cells/ResistanceResistance

ImmunoImmuno‐‐therapytherapy

EpigeneticsEpigeneticsNextNext

GenerationGenerationBiologicsBiologics

ProteinProteinHomeostasisHomeostasis

OTEZLA+OTEZLA+CombinationsCombinations

NovelNovelTargets FitTargets Fitfor Purposefor Purpose

FibrosisFibrosis

+PDE4 Complementation

+PKC

screens from Breaking Tumor

Tolerance

yConvergentMechanisms,

Synthetic LethalCombinations

PLATFORMS

RationalRationalCombinationsCombinations

Powerful ModelPowerful Model

• Robust campaigns, strategic optionality• Create / leverage data breakthroughs• Synergistic success with our partners

17

• Synergistic success with our partners

Advancing the Early-to-Mid Stage Pipeline to Go / No-go Decisions Within the Next 24 Months

ACYACY--12151215SotaterceptSotatercept• Renal

PDAPDA--002002• Diabetic

Foot Ulcers

AGAG--120120• IDH1 AML• Solid Tumors

EPZEPZ--56765676

• MyelomaDemcizumabDemcizumab

• NSCLC• PanC

Renal Anemia

• DOT1L MLL

MOR 202MOR 202• Myeloma • DLBCL

CCCC--122122 CCCC--9000190001• Fibrosis

VTXVTX--23372337• Ovarian • HNSCC

y• AML • CLL

CCCC--486486• Solid Tumors

• Fibrosis

CCCC--220220• Systemic

Lupus

18

Lupus

Celgene Business Development & Alliance Management Leads BCG Survey

19

Source: “Bigger Licensing Deals Require Better Partners”, Boston Consulting Group, Jan. 12, 2015

Strong Sales and Earnings Profile

Product Sales($B)

EPS1

($)

23%CAGR

>$20>$12.50

18%CAGR CAGR

$13-$14 ~$7.50

CAGR

$7.6 $3.71

2014 2017E 2020E 2014 2017E 2020E

20

Notes: 1) Adjusted

2020 and Beyond: Driving Sustainable, High Growth

On Track to Meet or On Track to Meet or Strong Growth Strong Growth Creating the Future Exceed 2017 TargetsExceed 2017 Targets

gExpected to 2020

gExpected to 2020

gBeyond 2020

• Existing products t t j t

• Label expansions,d t

• Robust campaigns, t t i ti lit

18%

on strong trajectory new products strategic optionality

CAGR

2014 2020E

21

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 H2

• Submit REVLIMID® for non-del5q MDS in U.S. and Japan 2015

• Presentation of FLASH meta-analysis on durable CR in follicular NHL H1

• Initiate enrollment in REVLIMID® Ph III ROBUST trial in DLBCL H1Initiate enrollment in REVLIMID Ph III ROBUST trial in DLBCL H1

• EU regulatory decision on ABRAXANE® in NSCLC Mar 2015

• Regulatory decision on POMALYST® for RRMM in Japan H1

• Complete enrollment in REVLIMID® Ph III CONTINUUM trial in CLL H2

Hematology& Oncology

• CHMP opinion on VIDAZA® for elderly AML H2

• Advance CC-122 in Ph I/II trials in DLBCL H2

• Initiate sotatercept / luspatercept in Ph III trial in beta-thalassemia H2

• Initiate pivotal program with AG-221 in AML with IDH-2 mutation H2Initiate pivotal program 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 H2I & I• Initiate GED-0301 in clinical program in ulcerative colitis H2

• Complete enrollment in CC-220 Ph II trial in SLE H2

22

Cowen 35th Annual Health Care ConferenceMarch 4, 2015

Reconciliation Tables

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Appendix

Celgene Pipeline

27

Celgene Pipeline

28

Celgene Pipeline

29

REVLIMID® Multiple Myeloma Late Stage Programs

Patient Population NDMM Non-ASCT Eligible NDMM Non-ASCT Eligible

Trial Name MM-015MM-020

Trial Name MM-015FIRST®

Phase III III

Target Enrollment 459 1,623

Design

Arm A: REVLIMID® (10mg)/melphalan/ prednisone for 9 cycles followed by REVLIMID® (10mg) maintenance to

disease progressionArm B: REVLIMID® (10mg)/melphalan/

prednisone for 9 cycles followed by placebo

Arm A: REVLIMID® (25mg)/low-dose dexamethasone until disease progression

Arm B: REVLIMID® (25mg)/low-dose dexamethasone for 18 4-week cycles g prednisone for 9 cycles followed by placebo

maintenance to disease progressionArm C: Melphalan/prednisone for 9 cycles

followed by placebo maintenance to disease progression

(72 weeks)Arm C: THALOMID®/melphalan/prednisone

for 12 6-week cycles (72 weeks)

P i E d i tPrimary Endpoint Progression Free Survival Progression Free Survival

Status

Study met primary endpoint July 2009Data presented at ASH 2009 with follow-up data at ASCO 2010, ASH and IMW 2011,

ASH 2012 and IMW 2013 PFS2 presented

Enrollment completeTrial met primary endpoint for PFS

Final PFS and interim OS presented at ASH 2013ASH 2012 and IMW 2013. PFS2 presented

at ASH 2013. Published in NEJM May 2012Follow-up continuing

ASH 2013REVLIMID® approved for NDMM in U.S. and

EU

30


Patient Population Maintenance Post-ASCT Maintenance Post-ASCT

Trial Name CALGB 100104 IFM 2005-02

Phase III III

Target Enrollment 459 614

DesignArm A: REVLIMID® (10mg) until disease

progression Arm B: Placebo until disease progression

Arm A: REVLIMID® consolidation (25mg) for 2 cycles followed by REVLIMID®

(10-15mg) until disease progressionArm B: REVLIMID® consolidation (25mg)

for 2 cycles followed by placebo until disease progressiondisease progression

Primary Endpoint Time to Progression Progression Free Survival

Trial met primary endpoint in Dec 2009Data presented at ASCO 2010. Follow-up

Trial met primary endpoint in June 2010Data presented at ASCO 2010. Follow-up

StatusData presented at ASCO 2010. Follow up

data at ASH 2010, IMW 2011 and IMW 2013.

Published in NEJM May 2012Follow-up for survival continuing

Data presented at ASCO 2010. Follow up data at ASH 2010, IMW 2011 and

ASH 2013.Published in NEJM May 2012

Follow-up for survival continuing

31


Patient Population Maintenance Post-VMP induction

Trial Name MM-026Trial Name

Phase III

Target Enrollment 350

2:1 randomization

Design

2:1 randomizationInduction with

Melphalan/prednisone/bortezomib (VMP) for 6-9 cycles

Arm A: REVLIMID® (10mg) d 1-21 for 28 day cyclefor 28-day cycle

Arm B: Placebo d 1-21 for 28-day cycle

Primary Endpoint Progression Free Survival

Status Trial enrollingStatus Trial enrolling

32


Patient Population Maintenance in ASCT EligibleTrial Name MYELOMA XI

Phase 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)

Design

( g) y ( g) ( g)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

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 Survival

StatusTrial enrolling

Possible interim data in mid-2015E

33

POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs

Patient Population RRMM

Trial NameMM-007

Trial NameOPTIMISMM

Phase III

T t E ll t 782Target Enrollment 782

Design

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 Survivaly p g

Status Trial enrolling

34

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 metStatus

yData presented at ASH 2014

Submission to FDA expected in 2015Trial enrolling

35

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


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 2014

S b itt d t EU i 2014Trial enrolling

Submitted to EU in 2014g

36

REVLIMID® Chronic Lymphocytic Leukemia Late Stage Programs

Patient Population Elderly Newly Diagnosed CLL Maintenance in 2nd Line CLL

Trial NameCLL-008 CLL-002

Trial NameORIGIN® CONTINUUM®

Phase III III


D i

Arm A: REVLIMID® (starting dosage 5mg/day escalated to 10mg/day) until disease progression 28 day cycle

Arm A: REVLIMID® (starting dosage 2.5mg/day escalated to 10mg/day) until

Design disease progression – 28-day cycleArm B: Chlorambucil (0.8 mg/kg) D1-15 for

~13 cycles (12 months) of 28-day cycle

g y g y)disease progression - 28-day cycle

Arm B: Placebo

Primary Endpoint Progression Free Survival Overall Survival and ProgressionFree Survivaly p g Free Survival

Status

Enrollment completeTrial put on clinical hold & discontinued

in July 2013Data to be presented at a future

Trial enrollingEnrollment to complete in 2015E

Data to be presented at a future medical congress

37

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 complete

38

Status Enrollment complete Enrollment complete


Patient Population Relapsed or Refractory Follicular Lymphoma

Untreated Activated B-Cell DLBCL

T i l NAUGMENTTM ROBUSTTM

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

39


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



40

ABRAXANE® Solid Tumor Late Stage Programs

Patient PopulationMaintenance After Induction in

Squamous Non-Small Cell Lung Cancer

Adjuvant Therapy in Surgically Resected Pancreatic Cancer

Trial Name NSCL-003 PANC-003

Phase III III


Induction: ABRAXANE® (100 mg/m2) D 1, 8,and 15 / Carboplatin (6 mg min/mL) D 1 for

4 21-day cycles A A ABRAXANE® (125 / 2) / G it bi

Design

4 21-day cyclesMaintenance:

Arm A: ABRAXANE® (100 mg/m2) D 1 and 8 plus BSC until disease progression –

21-day cycle

Arm A: ABRAXANE® (125 mg/m2) / Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28-day cyclesArm 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

41

Status Trial enrolling Trial enrolling

ABRAXANE® Solid Tumor Late Stage Programs

Patient Population First-Line Triple Negative Metastatic Breast Cancer

tnAcity™Trial Name

tnAcity™ABI-007-MBC-001

Phase II/III

Target Enrollment 240/550Target Enrollment 240/550

Phase IIArm A: ABRAXANE® 1(25mg/m2) / Gemcitabine

(1000 mg/m2) D 1 and 8 – 21-day cycleArm B: ABRAXANE® (125mg/m2) / Carboplatin

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® armp

Arm 2: Gemcitabine (1000 mg/m2) / Carboplatin AUC 2 IV, D 1 and 8 – 21-day cycle


42


I&I Late Stage Programs

Patient Population

Untreated Moderate-to-Severe

Late Stage Psoriatic Arthritis

Moderate-to-Severe Plaque Psoriasis Active Behçet’s Disease

Molecule OTEZLA® OTEZLA® OTEZLA®

Trial Name PSA-006 PSOR-010BCT-002RELIEFTM

Phase III IIIb III

Target Enrollment 214 240 204

Arm A: OTEZLA® single agent (30mg)

Arm A: OTEZLA® (30 mg) twice daily

Arm A; Placebo for 12 weeks followed by 30mg OTEZLA®

i d il f 2 kDesign(30mg)

twice dailyArm B: Placebo

Arm B: Etanercept (50 mg subcutaneous) once weekly

Arm C: Placebo

twice daily for 52-weeksArm B: 30mg OTEZLA® twice

daily for 64 weeks

Primary ACR 20 t W k 16 PASI75Area under the curve (AUC) for th b f l l fPrimary

Endpoint ACR 20 at Week 16 PASI75 the number of oral ulcers from baseline through week 12

Status Enrolling Enrollment complete Trial enrollingStatus g p g

43

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