35 Annual JP Morgan Healthcare Conference › 483522778 › files › doc... · JP Morgan...
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35th Annual JP Morgan Healthcare Conference
January 9, 2017
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
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Our Mission and VisionOur Mission and Vision
Celgene is building a preeminent global biopharmaceutical company focusedon the discovery, development and commercialization of innovative therapies for patients with cancer, immune-inflammatory, and other unmet medical needs
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Forward Looking Statements and Adjusted Financial InformationForward Looking Statements and Adjusted Financial Information
This presentation contains forward-looking statements, which are generally statements that are not historical facts. Forward-lookingstatements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook,” “targets” andsimilar expressions. Forward-looking statements 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-looking statement in light of new informationor future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of whichare difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by theforward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our AnnualReport on Form 10-K and our other reports filed with the Securities and Exchange Commission.
In addition to unaudited financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted financialmeasures. Further information relevant to the interpretation of adjusted financial measures, and reconciliations of these adjusted financialmeasures to the most comparable GAAP measures, may be found in the Appendix and on our website at www.Celgene.com in the“Investor Relations” section.
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2016 – A Year with Significant Momentum2016 – A Year with Significant Momentum
Delivered onKey Commercial Drivers
ProgressedEarly-to-Mid Stage Assets
AdvancedPhase III Trials
9Phase II
18Phase I
42Preclinical
Expanded and Addedto Our R&D Engine
Acquisitions
Collaborations
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Robust R&D Engine
Robust R&D Engine Delivering First- and Best-in-Class ProgramsRobust R&D Engine Delivering First- and Best-in-Class Programs
Centersof Excellence
Partner Network
Epigenetics
Immuno-Oncology
Inflammation & Immunology
Advanced 8 New Programsinto the Clinic
Protein Homeostasis Next-Gen CELMoD®
Ph I for AML
MAb targeting TIGIT Ph I for solid tumors
MAb targeting ICOS Ph I for solid tumors
LSD1 inhibitor Ph I for solid tumors
CC-90009
TIGIT JTX-2011
CC-90011
ROR-gamma agonist Ph I for solid tumors
MAb PD1 agonist Ph I for psoriasis
Lipid metabolism inhibitor Target indication: NASH
ATPase modulator Ph II for UC
LYC-55716 CC-90006
FT-4101 LYC-30937
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Blockbuster Products with Unique Value PropositionsBlockbuster Products with Unique Value Propositions
Market leader in multiple myeloma – expanding share & duration − Non-transplant NDMM reimbursed in 19 countries; TE Maintenance filed in US & EU− Established clinical synergy in approved novel triplet combinations
A standard of care in 3rd-Line+ multiple myeloma− Approved in 58 countries; increasing market share and treatment duration− Emerging backbone therapy with novel triplet combinations under evaluation
Most successful launch in the psoriasis / psoriatic arthritis category − Global expansion advanced: reimbursed in 23 countries; Japan approved in December− Advancing robust life cycle management across multiple indications
Global market leading branded therapy for metastatic pancreatic cancer− Adjuvant pancreatic cancer trial enrollment complete; data expected in 2017− Advancing Phase III I/O combinations in NSCLC and triple negative breast cancer
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2012 2013 2014 2015 2016*
Guidance Actual
2012 2013 2014 2015 2016*
Guidance Actual
Operating Excellence Is Driving High Growth & Financial OverperformanceOperating Excellence Is Driving High Growth & Financial Overperformance
25%CAGR
20%CAGR
$5.5$6.5
$7.7
$9.3
$11.2
Adjusted Diluted EPS($)
Total Revenue($B)
$2.45$2.98
$3.71
$4.71
~$5.94
*2016 amounts are preliminary and unaudited
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2017 Guidance Reflects Strong Business Momentum2017 Guidance Reflects Strong Business Momentum
18y/y growth
%
Total Revenue
+%21
EPS y/y growth*
150 bpsimprovement
Operating margin*
$8.0-8.3B
~$1.0B
$1.5-1.7B
$13.0-13.4B
Total Revenue
Diluted sharesoutstanding
~815M
$7.10 - $7.25 AdjustedEPS
~$1.6B
+
*Adjusted financial measureNote: Calculation of YoY growth is from unaudited 2016 measurements to the mid-point of the range
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$11.2
>$21
2016* 2020E
Delivering Industry-Leading, Volume-Driven GrowthDelivering Industry-Leading, Volume-Driven Growth
Adjusted Diluted EPS($)
Total Revenue($B)
~$5.94
>$13.00
2016* 2020E
22%CAGR
17%CAGR
*2016 amounts are preliminary and unaudited; 2020 targets at currency exchange rates on January 9, 2017
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19
13
9
Entering a Pivotal Inflection Point with Multiple Value Drivers to Sustain Growth from 2020-2030Entering a Pivotal Inflection Point with Multiple Value Drivers to Sustain Growth from 2020-2030
$13-13.4Brevenue
2017 >$21B revenue
2020
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Advancing a High Quality Pipeline with Significant PotentialAdvancing a High Quality Pipeline with Significant Potential
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, Beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
Celgene has an exclusive option to license Demcizumab, JTX-2011, LYC-55716, LYC-30937, OMP-131R10, OMP-305B83, and TIGIT
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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Expanding Our Leadership in Inflammation & ImmunologyExpanding Our Leadership in Inflammation & Immunology
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, Beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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Unique Value Proposition Robust Life Cycle Plan
OTEZLA®: A Blockbuster for Immune-Inflammatory DiseasesOTEZLA®: A Blockbuster for Immune-Inflammatory Diseases
EventExpected
Timing
Submit sNDAOnce daily formulation
Initiate Phase III TrialScalp Psoriasis
Phase III DataBehçet’s Disease
Phase II DataUlcerative Colitis
2017
2017
2017
2017
2018
Initiate Phase III TrialAnkylosing Spondylitis
PDE4 Inhibition Modulation of Target Inflammatory
Cytokines
Extracellular Pathways
Growing Market Position
0%
5%
10%
15%
20%
25%
30%
35%
40%
Psoriasis Market Share
Source: Symphony Prescriber-level data through week ending 9 December 2016; SHS PTD claims data. Dec ‘16 feed for month ending Oct ‘16
TNF-
Target
IL-12/23
Target
IL-17
Target
ENBREL®
STELARA®
HUMIRA®
OTEZLA®
COSENTYX®
Immune Cell
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Coming Soon... Phase III Ozanimod Data in Multiple SclerosisComing Soon... Phase III Ozanimod Data in Multiple Sclerosis
Potentially best-in-class next-generation S1P modulator
Phase III program for relapsing multiple sclerosis fully enrolled – SPA with FDA
Phase III data expected in H1:17
Planning NDA submission YE:17Safety: Most commonly reported AEs were minor infections
and headache
No noteworthy treatment-related occurrences of cardiac, pulmonary, serious opportunistic infections or malignancy adverse events
2-Year Phase II Data Supports ProfileOzanimod
0.51
0.22 0.18
Placebo (N=88)Ozanimod 1 mg (N=83) PBO controlled period (24 weeks)Ozanimod 1 mg (N=81) Blinded extension (2 years)
Annualized Relapse Rate
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Advancing a Portfolio of Oral, Complementary and Potentially Disruptive Therapies for Inflammatory Bowel DiseasesAdvancing a Portfolio of Oral, Complementary and Potentially Disruptive Therapies for Inflammatory Bowel Diseases
Mechanism of Action:
Next-Gen S1PModulator
OligonucleotideTargeting Smad 7
PDE4Inhibitor
Phase II Trial: Crohn’s DiseaseData Expected in 2017
Ulcerative ColitisData Expected in 2017
Ulcerative ColitisData Expected in 2017
Phase III Trial:Ulcerative ColitisData Expected in 2018
Crohn’s DiseaseData Expected in 2018 Ulcerative Colitis
Initiate in 2018
GED-0301Ozanimod
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Preparing for Upcoming Cascade of Global LaunchesPreparing for Upcoming Cascade of Global Launches
OTEZLA®
PsA / Psor2014
Multiple Potential Blockbuster Products Expected in I&ISignificant growth
through 2020and beyond
RMS2018E
UC2019E
CD2019EOzanimod
Ozanimod
GED-0301
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Defining New Standards of Care in Multiple MyelomaDefining New Standards of Care in Multiple Myeloma
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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Comprehensive Strategy Targets Unmet Needs in MyelomaComprehensive Strategy Targets Unmet Needs in Myeloma
1st Line
2nd Line
3rd Line
4th Line+
SCT Received Non-SCT Received
Frail (no triplets)
Failed IMiD® and PISwitch class doublets
Prior response >12 mo
Standard risk
Highrisk
Standard risk
Elderly frail
Highrisk
Sub-optimalresponse <12 mo
Patient Segments with High Unmet Need
Curative Potential High unmet need
Post-POMALYST®, Daratumumab, new MOAs
REVLIMID® / dexREVLIMID® Triplet
REVLIMID® / dexREVLIMID® Triplet
POMALYST® / dexPOMALYST® TripletREVLIMID® Triplet
POMALYST®/ dexPOMALYST® TripletREVLIMID® Triplet
Current & PotentialStandards of Care
CelgeneMyeloma Pipeline
Next-Gen CELMoD™ Agents
Next-Gen Epigenetic Agents
Immuno-Oncology Agents
Next-Gen Proteasome Inhibitors
CC-122 CC-220
EM901
Durvalumab
bb2121
ACY-241CC-486
Marizomib
CC-95821
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Targeting BCMA: A Potentially Disruptive Approach to Myeloma TherapyTargeting BCMA: A Potentially Disruptive Approach to Myeloma Therapy
CAR-TCells
TUMOR
3. Antibody Drug Conjugate
BCMA
TCells
2. Bispecific Antibody
BCMA
1. CAR-T Cell
BCMA
ChimericTCR
Cytotoxicgranules
Cytotoxicgranules
High value target that is uniformly expressed on myeloma cells
Emerging CAR-T clinical data validates potential in highly refractory disease
Advancing a comprehensive campaign with three distinct approaches:
1. bb2121: CAR-T in Ph I with bluebird bio
2. EM901: bispecific antibody expected to file IND by YE:2017
3. Antibody drug conjugates in preclinical development with Sutro Biopharma
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Expanding Our Portfolio in Myeloid DiseasesExpanding Our Portfolio in Myeloid Diseases
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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Transformative Therapies in Development for Myeloid DiseasesTransformative Therapies in Development for Myeloid Diseases
Potential first-in-class treatment for IDH2 mutant AML
Submitted NDA for relapsed refractory IDH2 mutant AML
Ph III IDHentify™ trial underway
Novel ligand trap for TGF- Superfamily
Ph III trials in RS+ MDS and beta-thalassemia underway
Trials in broader MDS and beta-thalassemia segments and myelofibrosis expected to begin in 2017
LuspaterceptEnasidenib
DurvalumabCC-486
Potentially best-in-class oral demethylating drug
Ph III QUAZAR® trials underway in MDS and AML maintenance; AML data expected in 2018
Additional trials planned in MDS and multiple myeloma
Anti-PD-L1 monoclonal antibody
Broad Ph I/II FUSION program underway:– MDS, AML, NHL, CLL and MM
Ph III enabling data expected in 2017
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Myelofibrosis
Celgene Myeloid Pipeline Covers the Entire Disease SpectrumCelgene Myeloid Pipeline Covers the Entire Disease Spectrum
β-Thalassemia
β-Thalassemia SpectrumRegularly TransfusedOccasionally Transfused
+
RS+, ESA Refractory or Ineligible
AML
Front-Line Fit Patients
Elderly Maintenance
after IC
Elderly-1st Line
AML 2nd Relapse
Higher-Risk
MDS
Del 5q
Lower-Risk, RBC TD
Low Platelet
MDS Spectrum
+
+
HMA failures
AML Spectrum
Myelofibrosis
CC-486
CC-486
CC-486
CC-90009
Durvalumab
DurvalumabDurvalumab
LuspaterceptLuspatercept
Luspatercept
Luspatercept
Luspatercept
Enasidenib
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Establishing a Lymphoma and Leukemia Franchise Establishing a Lymphoma and Leukemia Franchise
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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Broad program with novel agents in NHL and CLL Exploring potential synergy
in combination with CAR-T
Advancing Novel Immunotherapies for NHL and CLLAdvancing Novel Immunotherapies for NHL and CLL
YE:17YE:171st Line Follicular
Rel / Ref Follicular
Trial Expected DataComprehensive Phase III Program
YE:17YE:17
Rel / Ref Indolent 20192019
1st Line ABC DLBCL 20182018
CC-122
Ph I/II trials underway: NHL, CLL and MM Pivotal program initiation expected in 2017
Durvalumab
Interim analysis shows high CR rates in Ph I NHL trial Generally manageable cytokine release syndrome
and neurotoxicity Initiate pivotal program in 2017
JCAR017
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REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
Building a Solid Tumor Portfolio on the ABRAXANE® FoundationBuilding a Solid Tumor Portfolio on the ABRAXANE® Foundation
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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Near-term Opportunities in Solid Tumors Near-term Opportunities in Solid Tumors
IMpower 130
IMpower 131
Adjuvant PanC
Elderly NSCLC
NSCLC I/O Combo
NSCLC I/O Combo
TNBC I/O Combo
YE:17YE:17
Trial Expected DataComprehensive Phase III Program
20172017
20182018
20182018
20182018
Next-generation proteasome inhibitor that uniquely crosses the blood-brain-barrier
Ph I/II combo data in GBM encouraging
Targeting pivotal program initiation in 2017
Potentially first-in-class Anti-DLL4 MAb
Ph II PanC combo trial with ABRAXANE®
underway
Data expected in H1:17
Marizomib
DemcizumabSquamous NSCLC20182018
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Advancing a High Quality Pipeline with Significant PotentialAdvancing a High Quality Pipeline with Significant Potential
REVLIMID®
Del 5q MDS
VIDAZA®
MDS, AML
EnasidenibIDH2 AML
LuspaterceptMDS, Beta-thalassemia
CC-486 MDS, AML
DurvalumabMDS, AML
CC-90002AML
CC-90009AML
PNK-007AML
MyeloidDisease
9
MarizomibGBM
DemcizumabPanC, NSCLC
CC-486NSCLC, mBC
CC-122HCC
CC-90002Solid TumorsCC-90011
Solid Tumors
ABRAXANE®
PanC, NSCLC, mBC
AG-881Glioma
SolidTumors
13
TIGITSolid Tumors
OMP-305B83Solid Tumors
OMP-131R10Solid Tumors
LYC-55716Solid Tumors
JTX-2011Solid Tumors
Inflammation& Immunology
12OzanimodIBD, MS
OTEZLA®
PSOR, PSA
OTEZLA®
Behçet's, AS
GED-0301IBD
RPC-4046EoE
OTEZLA®
UCCC-220
SLE
CC-90001 IPF
CC-90006PSOR
FT-4101NASH
LYC-30937UC, PSOR
ABX-1431Neuro, Pain
MarketPh I
L E G E N D
REVLIMID®
MCL
ISTODAX®
PTCL, CTCL
REVLIMID®
NHLCC-122NHL, CLL
JCAR017NHL
DurvalumabNHL, CLL
CC-486NHL
Lymphoma& Leukemia
7
REVLIMID®
NDMM, RRMM
POMALYST®
RRMM
THALOMID®
NDMM, RRMM
CC-122RRMM
CC-220RRMM Durvalumab
NDMM, RRMM
bb2121RRMM
PNK-007RRMM
MarizomibRRMM
ACY-241RRMM
CC-486RRMM
MultipleMyeloma
11
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19
9
TIGIT JTX-2011 CC-90002CC-9000113
CC-95821
2020
Entering a Pivotal Inflection Point with Multiple Value Drivers to Sustain Growth from 2020-2030Entering a Pivotal Inflection Point with Multiple Value Drivers to Sustain Growth from 2020-2030
>$21B revenue
2020
$13-13.4Brevenue
2017
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bb2121
Luspatercept
<$500M $1B >$2B
2022CC-220
Pipeline Targets High Unmet Medical Need andProvides Significant, Long-term Commercial OpportunitiesPipeline Targets High Unmet Medical Need andProvides Significant, Long-term Commercial Opportunities
2018
2017
2019
DrugPotentialApproval
CurrentPeak Potential Drug
Potential Approval
CurrentPeak Potential
Ozanimod
Enasidenib
GED-0301
2020CC-486
2020
2021ACY-241
2020
JCAR017
2019
2021Marizomib
2021Demcizumab
2019
Durvalumab
2021CC-122
2021RPC-4046
Note: First Durvalumab approval for a hematologic malignancy
L E G E N DCurrent Estimate of
Peak Sales Potential:
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S U M M A R Y
Strong Momentum. Approaching Inflection PointS U M M A R Y
Strong Momentum. Approaching Inflection Point
Increasing Momentum
Key commercial growth drivers in place
Significant Inflection
Significant pipeline catalysts expected
Promising Future
Positioned to grow beyond 2020
2012 2013 2014 2015 2016 20302021
2017$13-13.4B
revenuerevenue
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2017 Milestones2017 Milestones
Financial Performance Total Revenue $13.0B-$13.4B Net REVLIMID® sales $8.0B-$8.3B Net POMALYST® sales ~$1.6B Net OTEZLA® sales $1.5B-$1.7B Net ABRAXANE® sales ~$1.0B Adj. operating margin +150bps Adj. Diluted EPS $7.10-$7.25
Clinical Data Ph III apact® – ABRAXANE® in adjuvant PanC Ph III RELEVANCE – REVLIMID® in 1st line FL Ph III AUGMENT® – REVLIMID® in RR FL Ph III Ozanimod in multiple sclerosis (SUNBEAM and RADIANCE) Ph II CC-486 with fulvestrant in ER+ HER2- mBC Ph II Demcizumab in NSCLC (DENALI) Ph II Demcizumab in PanC (YOSEMITE) Ph II OTEZLA® in UC Ph II GED-0301 in UC Ph II STEPSTONE - Ozanimod in CD Ph I/II Durvalumab in RRMM and 1st Line MDS and AML
Trial Enrollment Complete enrollment in Ph III CD-002 – GED-0301 in CD Complete enrollment in Ph III OPTIMISSM® trial
– POMALYST® in 2nd Line MM Complete enrollment in Ph III ROBUST® - REVLIMID® in DLBCL Complete enrollment in Ph III QUAZAR® - CC-486 in AML Complete enrollment in Ph III MEDALISTTM – Luspatercept in MDS Complete enrollment in Ph III BELIEVETM – Luspatercept in beta-thalassemia Complete enrollment in Ph III RELIEF® – OTEZLA® in Behçet’s Complete enrollment in Ph III TRUE NORTH – Ozanimod in UC
Regulatory Submissions/Decisions FDA approval of REVLIMID® in post-ASCT maintenance EU approval of REVLIMID® in post-ASCT maintenance Submit sNDA for RVd in NDMM File NDA for Enasidenib in IDH2-mutated AML Submit sNDA for OTEZLA® once-daily formulation Submit NDA for Ozanimod in RMS
Trial Initiations Initiate pivotal trial with CC-122 in NHL Initiate pivotal trial with bb2121 in RRMM Initiate pivotal trial with JCAR017 in NHL Initiate Ph III trial with OTEZLA® in scalp PSOR Initiate Ph III trial with OTEZLA® in AS Initiate Ph III trial with RPC-4046 in EoE Initiate pivotal trial with Marizomib in GBM Initiate Ph II trial with Luspatercept in myelofibrosis
R&ED File at least 8 IND’s
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Reconciliation TablesReconciliation Tables
Use of Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this document also contains certain non-GAAP financial measures based on management’s view of performance including:
• Adjusted research and development expense• Adjusted selling, general and administrative expense• Adjusted operating margin• Adjusted net income• Adjusted earnings per share
Management uses such measures internally for planning and forecasting purposes and to measure the performance of the Company. We believe these adjusted financial measures provide useful and meaningful information to us and investors because they enhance investors’ understanding of the continuing operating performance of our business and facilitate the comparison of performance between past and future periods. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. When preparing these supplemental non-GAAP financial measures we typically exclude certain GAAP items that management does not consider to be normal, recurring, cash operating expenses but that may not meet the definition of unusual or non-recurring items. Other companies may define these measures in different ways. The following categories of items are excluded from adjusted financial results:
Acquisition and Divestiture-Related Costs: We exclude the impact of certain amounts recorded in connection with business combinations and divestitures from our adjusted financial results that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization of acquired intangible assets, amortization of purchase accounting adjustments to inventories, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of contingent consideration. We also exclude transaction and certain other cash costs associated with business acquisitions and divestitures that are not normal recurring operating expenses, including severance costs which are not part of a formal restructuring program.
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Reconciliation TablesReconciliation Tables
Share-based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued.
Collaboration-related Upfront Expenses: We exclude collaboration-related upfront expenses from our adjusted financial results because we do not consider them to be normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. Upfront payments to collaboration partners are made at the commencement of a relationship anticipated to continue for a multi-year period and provide us with intellectual property rights, option rights and other rights with respect to particular programs. The variability of amounts and lack of predictability of collaboration-related upfront expenses makes the identification of trends in our ongoing research and development activities more difficult. We believe the presentation of adjusted research and development, which does not include collaboration-related upfront expenses, provides useful and meaningful information about our ongoing research and development activities by enhancing investors’ understanding of our normal, recurring operating research and development expenses and facilitates comparisons between periods and with respect to projected performance. All expenses incurred subsequent to the initiation of the collaboration arrangement, such as research and development cost-sharing expenses/reimbursements and milestone payments up to the point of regulatory approval are considered to be normal, recurring operating expenses and are included in our adjusted financial results.
Research and Development Asset Acquisition Expense: We exclude costs associated with acquiring rights to pre-commercial compounds because we do not consider such costs to be normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. Research and development asset acquisition expenses includes expenses to acquire rights to pre-commercial compounds from a collaboration partner when there will be no further participation from the collaboration partner or other parties. The variability of amounts and lack of predictability of research and development asset acquisition expenses makes the identification of trends in our ongoing research and development activities more difficult. We believe the presentation of adjusted research and development, which does not include research and development asset acquisition expenses, provides useful and meaningful information about our ongoing research and development activities by enhancing investors’ understanding of our normal, recurring operating research and development expenses and facilitates comparisons between periods and with respect to projected performance.
Restructuring Costs: We exclude costs associated with restructuring initiatives from our adjusted financial results. These costs include amounts associated with facilities to be closed, employee separation costs and costs to move operations from one location to another. We do not frequently undertake restructuring initiatives and therefore do not consider such costs to be normal, recurring operating expenses.
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Reconciliation TablesReconciliation Tables
Certain Other Items: We exclude certain other significant items that may occur occasionally and are not normal, recurring, cash operating expenses from our adjusted financial results. Such items are evaluated on an individual basis based on both the quantitative and the qualitative aspect of their nature and generally represent items that, either as a result of their nature or magnitude, we would not anticipate occurring as part of our normal business on a regular basis. While not all-inclusive, examples of certain other significant items excluded from adjusted financial results would be: expenses for significant fair value adjustments to equity investments, significant litigation-related loss contingency accruals and expenses to settle other disputed matters.
Estimated Tax Impact From Above Adjustments: We exclude the net income tax impact of the non-tax adjustments described above from our adjusted financial results. The net income tax impact of the non-tax adjustments includes the impact on both current and deferred income taxes and is based on the taxability of the adjustment under local tax law and the statutory tax rate in the tax jurisdiction where the adjustment was incurred.
Non-Operating Tax Adjustments: We exclude the net income tax impact of certain other significant income tax items, which are not associated with our normal, recurring operations (“Non-Operating Tax Items”), from our adjusted financial results. Non-Operating Tax Items include items which may occur occasionally and are not normal, recurring operating expenses (or benefits), including adjustments related to acquisitions, divestitures, collaborations, certain adjustments to the amount of unrecognized tax benefits related to prior year tax positions, and other similar items.
Long-Term Targets
A reconciliation of long-term adjusted financial targets to the most comparable GAAP measures cannot be provided because we are unable to forecast with reasonable certainty many of the items necessary to calculate such comparable GAAP measures, including share-based compensation expense, collaboration-related upfront expense, research and development asset acquisition expense, acquisition-related expenses, fair value adjustments to contingent consideration, the ultimate outcome of legal proceedings and unusual gains and losses, as well as unforeseen events, risks and developments. These items are uncertain, depend on various factors, and could be material to our results computed in accordance with GAAP. We believe the inherent uncertainties in reconciling our long-term non-GAAP measures to the most comparable GAAP measures would make the forecasted comparable GAAP measures nearly impossible to predict with reasonable certainty and therefore inherently unreliable.
See the attached Reconciliation of Estimate / Projected GAAP to Adjusted (Non-GAAP) Measures for explanations of the amounts excluded and included to arrive at the adjusted measures for the three-month and full year periods ended December 31, 2016, and for the projected amounts for the year ending December 31, 2017.
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Low High Low High Low HighEstimated/projected diluted earnings per common share - GAAP (1) 0.49$ 0.57$ 2.43$ 2.51$ 5.85$ 6.21$
Per share impact of excluded items before tax:Cost of goods sold (excluding amortization of acquired intangible assets):
Share-based compensation expense (2) 0.01 0.01 0.04 0.04 0.04 0.04
Research and development:Share-based compensation expense (2) 0.08 0.08 0.32 0.32 0.34 0.32 Collaboration-related upfront expense (1)(3) 0.16 0.16 1.02 1.02 - - Research and development asset acquisition expense (1)(4) 0.34 0.34 1.11 1.11 0.37 0.37
Selling, general and administrative:Share-based compensation expense (2) 0.10 0.10 0.40 0.40 0.43 0.40 Litigation-related loss contingency accrual expense (1)(5) 0.09 0.09 0.25 0.25 - -
Amortization of acquired intangible assets (1)(6) 0.15 0.11 0.59 0.55 0.45 0.41
Acquisition related (gains) charges and restructuring, net:Change in fair value of contingent consideration (1)(7) 0.02 0.01 0.04 0.03 0.18 0.16 Restructuring charges (8) - - 0.02 0.02 - -
Other income (expense), net:Equity investment adjustment (1)(9) 0.34 0.34 0.34 0.34 - -
Income tax provision:Estimated tax impact from above adjustments (10) (0.06) (0.09) (0.51) (0.54) (0.56) (0.66) Non-operating tax adjustments (11) (0.11) (0.11) (0.11) (0.11) - -
Estimated/projected diluted earnings per common share - Adjusted 7.10$ 7.25$
Low High Low High
Operating margin percentage of revenue - GAAP (1) 27.8% 28.1% 45.1% 46.1%Plus adjustments:
Share-based compensation expense (2) 5.4% 5.4% 5.1% 4.6%Collaboration-related upfront expense (1)(3) 7.3% 7.3% 0.0% 0.0%Research and development asset acquisition expense (1)(4) 8.0% 8.0% 2.3% 2.2%Litigation-related loss contingency accrual expense (1)(5) 1.8% 1.8% 0.0% 0.0%Amortization of acquired intangible assets (1)(6) 4.2% 4.0% 2.8% 2.5%Change in fair value of contingent consideration (1)(7) 0.3% 0.2% 1.1% 1.0%Restructuring charges (8) 0.1% 0.1% 0.0% 0.0%
Operating margin percentage of revenue - Adjusted 54.9% 54.9% 56.4% 56.4%
Explanation of adjustments:(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
Approximately $ 1.61
Our projected 2017 financial measures do not include the effect of any business combinations, collaboration agreements, asset acquisitions, asset impairments, additional litigation-related loss contingency accruals, changes in the fair value of our CVRs issued as part of the acquisition of Abraxis BioScience Inc. (Abraxis) or non-operating tax adjustments that may occur after the day prior to the date of this press release.Exclude share-based compensation expense.
Range Range
Range
Approximately $ 5.94
Range
Exclude the tax benefit of a loss related to a prior year acquisition.
Celgene Corporation and SubsidiariesReconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP) Measures
(Unaudited)
Twelve Months Ended Twelve Months Ending
December 31, 2016 December 31, 2017Three Months Ended Twelve Months EndingTwelve Months Ended
December 31, 2016 December 31, 2017
December 31, 2016
Range
Exclude upfront payment expense for research and development collaboration arrangements.Exclude research and development asset acquisition expenses; 2016 includes EngMab AG.Exclude loss contingency accrual expense related to a contractual dispute.
Fair value adjustment to our equity investment in Juno Therapeutics, Inc. per ASC 320 "Investments—Debt and Equity Securities."
Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila, Nogra Pharma Limited, and Quanticel.
Exclude the estimated tax impact from the above adjustments.
Exclude amortization of intangible assets acquired in the acquisitions of Pharmion Corp., Gloucester Pharmaceuticals, Inc. (Gloucester), Abraxis, Celgene Avilomics Research, Inc. (Avila), and Quanticel Pharmaceuticals, Inc. (Quanticel). The excluded expense for 2016 includes $101.5 million related to the impairment of an intangible asset acquired in the Avila acquisition.
Exclude restructuring charges related to our relocation of certain operations into our two Summit, NJ locations as well as costs associated with certain headcount reductions.