Escolar Documentos
Profissional Documentos
Cultura Documentos
35th Annual
JP Morgan Healthcare Conference
January 9, 2017
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 managements current plans, estimates, assumptions and projections, and
speak only as of the date they are made. We undertake no obligation to update any forward-looking statement 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 and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail 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.
Delivered on
Key Commercial Drivers
Advanced
Phase III Trials
Progressed
Early-to-Mid Stage Assets
Acquisitions
Phase II
9
Collaborations
Phase I
18
Preclinical
42
Protein Homeostasis
Epigenetics
Centers
of Excellence
Immuno-Oncology
Next-Gen CELMoD
Ph I for AML
TIGIT
Partner
Network
ROR-gamma agonist
Ph I for solid tumors
FT-4101
Lipid metabolism inhibitor
CC-90011
LSD1 inhibitor
Ph I for solid tumors
JTX-2011
ATPase modulator
Ph II for UC
($B)
($)
~$5.94
$11.2
20%
CAGR
25%
$9.3
CAGR
$7.7
$3.71
$6.5
$2.98
$5.5
2012
$4.71
$2.45
2013
2014
Guidance
2015
Actual
2016*
2012
2013
2014
Guidance
2015
Actual
2016*
$7.10 - $7.25
EPS y/y growth*
21
Total
Revenue
$13.0-13.4B
Total
Revenue
Adjusted
EPS
Operating margin*
150 bps
improvement
~815M
Diluted shares
outstanding
$8.0-8.3B
18
y/y growth
$1.5-1.7B
~$1.6B
~$1.0B
($B)
($)
>$13.00
>$21
22%
17%
CAGR
CAGR
$11.2
2016*
~$5.94
2020E
2016*
*2016 amounts are preliminary and unaudited; 2020 targets at currency exchange rates on January 9, 2017
2020E
19
2020
2017
$13-13.4B
revenue
>$21B
revenue
9
13
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, Beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
Celgene has an exclusive option to license Demcizumab, JTX-2011, LYC-55716, LYC-30937, OMP-131R10, OMP-305B83, and TIGIT
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, Beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
PDE4 Inhibition
40%
Extracellular Pathways
35%
HUMIRA
Target
IL-17
Scalp Psoriasis
ENBREL
15%
Ankylosing Spondylitis
10%
Phase II Data
COSENTYX
Target
0%
2017
2017
OTEZLA
5%
IL-12/23
Target
25%
20%
TNF-
Submit sNDA
Expected
Timing
STELARA
30%
Immune Cell
Ulcerative Colitis
Source: Symphony Prescriber-level data through week ending 9 December 2016; SHS PTD claims data. Dec 16 feed for month ending Oct 16
2017
2017
2018
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)
Safety:
Most commonly reported AEs were minor infections
and headache
No noteworthy treatment-related occurrences of
cardiac, pulmonary, serious opportunistic infections
or malignancy adverse events
Ozanimod
GED-0301
Mechanism of
Action:
Next-Gen S1P
Modulator
Oligonucleotide
Targeting Smad 7
PDE4
Inhibitor
Phase II Trial:
Crohns Disease
Ulcerative Colitis
Ulcerative Colitis
Ulcerative Colitis
Crohns Disease
Ulcerative Colitis
Initiate in 2018
RMS
2018E
CD
2019E
UC
2019E
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
1st Line
2nd Line
REVLIMID /
dex
REVLIMID Triplet
REVLIMID /
dex
REVLIMID Triplet
High
risk
Non-SCT Received
High
risk
Standard
risk
Sub-optimal
response <12 mo
Standard
risk
4th
Line
POMALYST / dex
POMALYST Triplet
REVLIMID Triplet
Line+
POMALYST/ dex
POMALYST Triplet
REVLIMID Triplet
CC-122
CC-220
Elderly frail
CC-95821
Prior response
>12 mo
Immuno-Oncology Agents
3rd
Celgene
Myeloma Pipeline
bb2121
EM901
Durvalumab
Next-Gen Epigenetic Agents
Switch class
doublets
CC-486
ACY-241
Post-POMALYST,
Curative Potential
Marizomib
1. CAR-T Cell
T
Cells
CAR-T
Cells
Chimeric
TCR
2. Bispecific Antibody
Cytotoxic
granules
Cytotoxic
granules
BCMA
BCMA
BCMA
TUMOR
3. Antibody
Drug Conjugate
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
Luspatercept
CC-486
Durvalumab
MDS
Higher-Risk
Lower-Risk, RBC TD
RS+, ESA Refractory or Ineligible
Del 5q
Front-Line
Fit Patients
Low Platelet
MDS Spectrum
Elderly
Maintenance
after IC
Elderly-1st
Line
AML 2nd
Relapse
AML Spectrum
Luspatercept
CC-486
Luspatercept
Durvalumab
HMA failures
-Thalassemia
Occasionally Transfused
Durvalumab
CC-90009
CC-486
Durvalumab
Myelofibrosis
Regularly Transfused
-Thalassemia Spectrum
Luspatercept
Myelofibrosis
Luspatercept
Luspatercept
Enasidenib
CC-486
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
Expected Data
YE:17
JCAR017
Interim analysis shows high CR rates in Ph I NHL trial
YE:17
2018
2019
Durvalumab
Broad program with novel agents in NHL and CLL
Exploring potential synergy
in combination with CAR-T
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
Expected Data
YE:17
Elderly NSCLC
Squamous NSCLC
IMpower 131
NSCLC I/O Combo
IMpower 130
NSCLC I/O Combo
2017
2018
2018
Demcizumab
Potentially first-in-class Anti-DLL4 MAb
2018
2018
ABRAXANE
CC-486
NDMM, RRMM
REVLIMID
RRMM
POMALYST
MCL
PanC, NSCLC
ISTODAX
Marizomib
Solid
Tumors
NHL
CC-486
13
NSCLC, mBC
Solid Tumors
OMP-305B83
Solid Tumors
PNK-007
RRMM
RRMM
CC-220
RRMM
REVLIMID
bb2121
Durvalumab
RRMM
CC-122
CC-122
NHL
Glioma
FT-4101
PSOR, PSA
AML
NASH
OTEZLA
VIDAZA
CC-90009
MDS, AML
CC-90006
Behet's, AS
PSOR
AML
LEGEND
Market
CC-90002
CC-90011 Solid Tumors
Solid Tumors
OTEZLA
PNK-007
Del 5q MDS
Solid Tumors
AG-881
NHL, CLL
REVLIMID
TIGIT
HCC
NHL, CLL
Durvalumab
NDMM, RRMM
Ph I
OMP-131R10
GBM
11
LYC-55716
Solid Tumors
Marizomib
JCAR017
Lymphoma
& Leukemia
PTCL, CTCL
RRMM
CC-122
JTX-2011
Solid Tumors
Demcizumab
RRMM
Multiple
Myeloma
NDMM, RRMM
NHL
ACY-241
RRMM
THALOMID
PanC, NSCLC,
mBC
CC-486
Myeloid
Disease
Enasidenib
IDH2 AML
CC-486
GED-0301
IBD
CC-90002
AML
Durvalumab
MDS, AML
MDS, AML
Luspatercept
MDS, Beta-thalassemia
Inflammation
& Immunology
12
Ozanimod
IBD, MS
ABX-1431
Neuro, Pain
LYC-30937
UC, PSOR
RPC-4046
CC-90001
EoE
IPF
OTEZLA
UC
CC-220
SLE
19
2020
2020
2017
>$21B
$13-13.4B
revenue
revenue
9
13
TIGIT
JTX-2011
CC-90001
CC-90002
CC-95821
Potential
Approval
Enasidenib
Current
Peak Potential
Drug
Potential
Approval
2017
bb2121
2020
Ozanimod
2018
Marizomib
2021
GED-0301
2019
Demcizumab
2021
JCAR017
2019
CC-122
2021
Luspatercept
2019
ACY-241
2021
Durvalumab
2020
RPC-4046
2021
CC-486
2020
CC-220
2022
Current
Peak Potential
LEGEND
Current Estimate of
Peak Sales Potential:
<$500M
$1B
>$2B
S U M M A R Y
Significant Inflection
Significant pipeline
catalysts expected
2017
$13-13.4B
Promising Future
Positioned to grow
beyond 2020
revenue
revenue
2012
2013
2014
2015
2016
2021
2030
2017 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
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
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 Behets
Complete enrollment in Ph III TRUE NORTH Ozanimod in UC
R&ED
File at least 8 INDs
Reconciliation 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
managements view of performance including:
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.
Reconciliation 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 sharebased 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.
Reconciliation 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.
(1)
0.01
0.01
0.04
0.04
0.04
0.04
(2)
(1)(3)
(1)(4)
0.08
0.16
0.34
0.08
0.16
0.34
0.32
1.02
1.11
0.32
1.02
1.11
0.34
0.37
0.32
0.37
(2)
(1)(5)
0.10
0.09
0.10
0.09
0.40
0.25
0.40
0.25
0.43
-
0.40
-
(1)(6)
0.15
0.11
0.59
0.55
0.45
0.41
(1)(7)
(8)
0.02
-
0.01
-
0.04
0.02
0.03
0.02
0.18
-
0.16
-
(1)(9)
0.34
0.34
0.34
0.34
(0.06)
(0.11)
(0.09)
(0.11)
(0.51)
(0.11)
(0.54)
(0.11)
(0.56)
-
(0.66)
-
(10)
(11)
Approximately $ 1.61
Approximately $ 5.94
7.10
7.25
(1)
27.8%
28.1%
45.1%
46.1%
(2)
(1)(3)
(1)(4)
(1)(5)
(1)(6)
(1)(7)
(8)
5.4%
7.3%
8.0%
1.8%
4.2%
0.3%
0.1%
54.9%
5.4%
7.3%
8.0%
1.8%
4.0%
0.2%
0.1%
54.9%
5.1%
0.0%
2.3%
0.0%
2.8%
1.1%
0.0%
56.4%
4.6%
0.0%
2.2%
0.0%
2.5%
1.0%
0.0%
56.4%
Explanation of adjustments:
(1)
(2)
(3)
(4)
(5)
(6)
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.
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.
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.
(7)
Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila, Nogra Pharma Limited, and Quanticel.
(8)
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.
(9) Fair value adjustment to our equity investment in Juno Therapeutics, Inc. per ASC 320 "InvestmentsDebt and Equity Securities."
(10) Exclude the estimated tax impact from the above adjustments.
(11) Exclude the tax benefit of a loss related to a prior year acquisition.