deutsche conference final · market opportunity $21b prevalence 2.3m source: market size...
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Deutsche Bank 43rd Annual Health Care Conference
May 8, 2018
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
Forward-Looking Statements and Adjusted Financial Information
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This presentation contains forward-looking statements, which are generally statements that are not historical facts.Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,”“plans,” “will,” “outlook,” “targets” and similar expressions. Forward-looking statements are based on management’scurrent plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertakeno obligation to update any forward-looking statement in light of new information or future events, except as otherwiserequired by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult topredict and are generally beyond our control. Actual results or outcomes may differ materially from those implied bythe forward-looking statements as a result of the impact of a number of factors, many of which are discussed in moredetail in our Annual Report 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 financial measures. Further information relevant to the interpretation of adjusted financial measures, and reconciliations of these adjusted financial measures 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.
Our Mission and Vision
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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
Deploying a Strategy to Grow Through 2020 and Beyond
ExecuteDeliveringon 2020
AcceleratePositioning toGrow Beyond
2020
ExpandCreating
SustainableGrowth
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Strong Volume-Driven Growth Expected in 2018
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14Y/Y Growth
%+%
EPS Y/Y growth*
~56%Operating Margin*
~$9.5B~ $14.8B
TotalRevenue
Tax Rate*
~17%
~ $8.45Diluted EPS*
~$2.0B
Total Revenue
~$1.5B ~$1.0B
*Adjusted financial measure which includes the impact of our acquisition of Juno Therapeutics Inc., which is expected to be dilutive to adjusted diluted EPS in 2018 by approximately $0.50.
~13.6%
MultipleMyeloma
Accelerating Diversification by Advancing Medicinesto Transform the Treatment of Diseases
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Market Opportunity$27BIncidence60K
HEMATOLOGY & ONCOLOGYNon-Hodgkin Lymphoma
Market Opportunity$17BIncidence90K
MyeloidDiseases
Market Opportunity$5BIncidence65K
Psoriasis / Psoriatic Arthritis
Market Opportunity$26BPrevalence5M
MultipleSclerosis
Market Opportunity$23BPrevalence650K
INFLAMMATION & IMMUNOLOGYInflammatory Bowel Disease
Market Opportunity$21BPrevalence2.3M
Source: Market size projections are for 2022 from Evaluate Pharma, December 2017 and Decision Resources Disease Landscape and Forecast; Epidemiology is for 2018 from Decision Resources Disease Landscape and Forecast, Kantar Health CancerMPact database and Putnam Associates
Innovative Therapies Are Transforming Multiple Myeloma
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+3 months
OS increase
Median Overall Survival(months)
Source: Drawid A et al. Impact of Novel Therapies on Multiple Myeloma – Current and Future Outcomes. Poster presented at the 20th Congress of the European Haematology Association; Vienna, Austria, June 11–14, 2015
Note: Historical median OS for MM patients based on analysis of the National Cancer Institute Surveillance, Epidemiology, and End Results Program; Predictive analysis of OS was modelled using data from clinical trials, cancer registries and insight from key opinion leaders.
Current Therapies
IMiD® Agents Proteasome Inhibitors Monoclonal Antibodies Novel Triplets
Immunotherapy
Future Therapies
+29months
Predicted OS increase
2932
43
72
1990 1995 2000 2005 2010 2015 2020
+11 months
OS increase
Targeting BCMA:A Potentially Disruptive Approach to Myeloma Therapy
*partnered program with bluebird bio**partnered program with Sutro Biopharma 8
T Cell Engager Antibody CC-93269 – phase I trial initiated
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1 CAR T Therapy bb2121* – pivotal KarMMa™ trial initiated bb21217* – phase I trial initiated JCARH125 – phase I trial initiated
3 Antibody Drug Conjugate BCMA ADC**– IND planned in early 2019
CAR TCells
TUMOR
3. Antibody Drug Conjugate
BCMA
TCells
2. T Cell Engager Antibody
BCMA
1. CAR T Therapy
BCMA
TCR
Cytotoxicgranules
Cytotoxicgranules
1 2
3
Targeting High Unmet Needs in NHL with Multiple Mechanisms
Note: REVLIMID® is not approved for follicular or diffuse Large B-cell non-Hodgkin lymphomaCDx: companion diagnostic 9
Diffuse Large B-cell Lymphoma Follicular Lymphoma
Indu
ctio
n
ABC UC GCB
1st
Rel
apse
SCT Eligible SCT Ineligible Relapsed / Refractory2nd
Rel
apse
+ Double Refractory
CC-122
REVLIMID®
AUGMENT™
CC-122CDx
Liso-cel
REVLIMID®
ROBUST®
CC-486
Liso-cel
CD19 CAR TLiso-cel (JCAR017) Potential best-in-class profile Pivotal program in DLBCL under way
EpigeneticsCC-486 Combo with R-CHOP in DLBCL at ASH ‘17 Additional POC trial planned in 2018
Key MechanismsProtein Homeostasis
REVLIMID®
AUGMENT™ data expected in 2018 ROBUST® data (event-driven)
CC-122 Initiate pivotal program in 2018
Next-gen CELMoD® Agents
Liso-cel – Emerging Favorable Profile in R/R DLBCL
Data include: JCAR017 CORE R/R DLBCL Phase I for both DL1S and DL2S groups (safety n=67; efficacy n=65 data cut-off October 9, 2017, ASH 2017); YESCARTA™ Phase II (n=101, ASCO 2017); and, KYMRIAH™ Phase II (safety n=99, efficacy n=46 ASH 2017). Data presented to show potential profile of JCAR017, which is subject to ongoing investigation, within context of other CAR T treatments. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse events across all patients treated in JCAR017 the study (n=91) other than CRS and NT that occurred at ≥25% included neutropenia (49%), anemia (38%), fatigue (37%), thrombocytopenia (29%), nausea (27%), and diarrhea (25%). Grade 1/2 events for CRS and NT were 34% and 6%, respectively.
42%36%
30%
Liso-cel YESCARTA KYMRIAHComplete Response PR
Response Rates at 6 Months Cytokine Release Syndrome
23%
13%
1%
KYMRIAH
YESCARTA
Liso-cel
Grade 1/2 Grade 3/4
Neurotoxicity
12%
28%
15%
KYMRIAH
YESCARTA
Liso-cel
Grade 1/2 Grade 3/4
SafetyEfficacy
Grade 1/2 Grade 3/4
Grade 1/2 Grade 3/4™™
™
™
™
™
Improving the Standard of Care Across Myeloid Diseases
IDHIFA®
Approved for R/R IDH2 mutant AML
1st Line AMLHigher-Risk MDSLower-Risk, RBC TD MDS 2nd Line AML
Luspatercept Ph III COMMANDS™
trial in front-line MDS Ph III MEDALIST™
trial in ESA refractory
REVLIMID®
Approved for del5q MDS
CC-486 Ph III QUAZAR®
trial in low-risk MDS
VIDAZA®
Approved for higher-risk MDS and elderly 1st-line AML
CC-486 PH III QUAZAR®
data in AML maintenance
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Luspatercept
Erythroid maturation agent (EMA) targeting severe chronic anemias
Ph II myelofibrosis trial initiated Ph III data expected in mid-18 Initiate Ph III trial in H1:18Ph III data expected in mid-18
Expected Data Presentations at ASCO 2018Expected Data Presentations at ASCO 2018
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Ph III OPTIMISMM® trial with POMALYST® in combination with bortezomib and dexamethasone (PVd) in 2nd line+ MM
Ph III RELEVANCE® trial with REVLIMID® in combination with rituximab (R²) in patients with previously untreated FL
Ph III IMpower131* trial with ABRAXANE® in combination with atezolizumab in squamous NSCLC
Updated data from Ph I trial with bb2121 in RRMM Updated data from pivotal TRANSCEND U.S. trial with liso-
cel (JCAR017) in relapsed or refractory DLBCL
* IMpower131 is a Genentech, a member of the Roche Group, sponsored clinical trial.
R&D Engine
Building a Pipeline of Next-Generation Growth Drivers
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Centers ofExcellence
Partner Network
Epigenetics
Immuno-Oncology
Inflammation & Immunology
Protein Homeostasis
Neuroscience & Imaging
Internal Innovation EngineAdvancing 8 New Programs into the Clinic
Next-Gen CELMoD®
Ph I for MM
BET inhibitor Ph I for solid
tumors
Mat2A inhibitor Ph I for solid
tumors
BCMA T cell engager
Ph I for MM
CC-92480
CC-90010 AG-270
CC-93269
BCMA CAR T Ph I for MM
CD3xCD33 bispecific
Ph I for AML
Anti-LIF1 MAb Ph I for solid tumors
GLP-1R modulator Targeted for NASH
bb21217
MSC-1 RPC8844
GEM333
Inflammation & Immunology Immuno-OncologyProtein Homeostasis Epigenetics
BGB-A317 Accelerates Our Solid Tumor I/O Strategy
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Reverse effector T cell exhaustion Anti-ICOS (JTX-2011) CELMoD® agent (CC-122)
Block regulatory T cells mediated immune suppression Anti-ICOS (JTX-2011) Anti-TIGIT (OMP-313-M32)
Stimulate Th17/Tc17 anti-tumor immunity ROR agonist (LYC-55716)
Activate the innate immune system TLR-8 agonist (motolimod)
Block immune suppressive cytokines Anti-LIF (MSC-1)
Induce macrophages to destroy tumor cells Anti-CD47 (CC-90002)
Tregcell
Teffectorcell
Tc17 /Th17 cell
NK
MDSC
Macrophages
Potentially differentiated anti-PD-1 MAbbased on engineered Fc region: potential to enhance anti-tumor activity by
preventing binding to Fc gamma receptor bind to unique PD-1 epitopes with high affinity
Evaluated in over 600 patients to date Demonstrated activity in a range of solid
tumors with an acceptable safety profile to support continued development Pivotal program plan initiated:
Hepatocellular carcinoma Non-small cell lung cancerEsophageal cancer
– Gastric cancer
Exploring combinatorial potential with emerging I/O agents
BGB-A317 (tislelizumab) Celgene’s Early Clinical Stage I/O Assets
Celgene has an exclusive option to license JTX-2011, OMP-313-M32, and an option to acquire LYC-55716
Building Leadership in a New Disease: Myelofibrosis (MF)
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Myelofibrosis
Market Opportunity$4BIncidence17K
Fedratinib – A Potential Blockbuster in MF
Addressing Unmet Needs in MF
Source: Market size projection is for 2022 from Evaluate Pharma, December 2017. Epidemiology from Titmarsh, G.J. et.al., American Journal of Hematology, 2014Physician Interviews; ClearView Analysis, September, 2017, n=35
Highly selective JAK2 kinase inhibitor Myelofibrosis clinical program completed to date:
− Ph III trial in treatment-naïve patients − Ph II trial in patients resistant or intolerant to Jakafi®
NDA submission for myelofibrosis planned in 2018 Accelerate ongoing myelofibrosis program with luspatercept, in addition to
early Protein Homeostasis and Epigenetic programs
~60%
~20%
~20%
Currently Receiving Jakafi®First-line, Low Platelet CountJakafi® Failures
Leading the Way in Cellular Immunotherapy
State-of-the-Art Manufacturing
CAR T technology: recognizes proteins on the
surface of cancer cells
TCR Technology: recognizes intracellular tumor-specific proteins
Broad and Deep
Pipeline
BCMA CAR T: bb2121*, bb21217*, JCARH125 CD19 CAR T: JCAR017 CD22: JCAR018 L1CAM: JCAR023 MUC16/ IL-12: JCAR020 ROR-1: JCAR024 LeY WT1: JCAR016
Celgene’s Cellular Immunotherapy Portfolio
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Innovative Cellular Engineering
*partnered program with bluebird bio
Delivering Industry-Leading Growth Through 2020…
Late-stage Pipeline with Potential to Add Over $16B in Incremental Peak Revenue Through 2030
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…And Positioned to Grow Beyond 2020
Expected to Launch Ten Potential Blockbusters
Adj. Diluted EPS
Revenue
~19%CAGR
14.5%CAGR
Note: CAGR calculation is from 2017 measurements to the midpoint of the 2020 total revenue range$16 billion represents sum of individual potential peak sales for each illustrated product, which may not coincide.
$1B >$2BL E G E N D
Current Estimate of Peak Sales Potential:
Deutsche Bank 43rd Annual Health Care Conference
May 8, 2018
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE