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Q2 2013 Conference CallJuly 25, 2013
Agenda
Patrick Flanigan, VP, Investor Relations
Bob Hugin, Chief Executive Officer
Jackie Fouse, Chief Financial Officer
Mark Alles, Head of Hematology/Oncology
Q&A
Scott Smith, Head of Inflammation & Immunology
2
Q&A
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 financial information prepared in accordance with U.S. GAAP, this presentation alsocontains adjusted financial measures that we believe provide investors and management withsupplemental information relating to operating performance and trends that facilitate comparisonsbetween periods and with respect to projected information. These adjusted financial measures arenon-GAAP and should be considered in addition to but not as a substitute for the informationnon GAAP and should be considered in addition to, but not as a substitute for, the informationprepared 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
3
of these adjusted financial measures to the most comparable GAAP measures, may be found onCelgene’s website at www.Celgene.com in the “Investor Relations” section.
Bob Hugin
Q2 2013: A Quarter of Outstanding Results
Exceptional Financial and Commercial Results:Strong Y/Y growth: net product sales ↑17% revenue ↑17% adjusted diluted EPS ↑25%Strong Y/Y growth: net product sales ↑17%, revenue ↑17%, adjusted diluted EPS ↑25%REVLIMID® continued expansion and positive momentumSuccessful POMALYST® launch in the US and ABRAXANE® trajectory
Advancing the Portfolio:Approvals for REVLIMID® in MCL in US and del5q MDS in EU Positive CHMP opinion for pomalidomidePositive CHMP opinion for pomalidomideStatistically significant PFS in MM-020 trialApremilast PsA submission in US; PSOR and EU submissions on track for H2
Building for the Future:Strengthening the early pipeline organically and through collaborationsDiscovery platforms producing development candidates
5
Advancing Towards the Next Phase of Growth
Maximize Full Potential of our Hematology Franchise1 Maximize Full Potential of our Hematology Franchise1
Expand our Oncology Franchise into New Indications2
Submit Apremilast with Regulators and Prepare for Launch3
Advance Early-Stage Clinical Programs to Key Decision Points4
6
Jackie Fouse
Q2 2013 Financial Highlights
Excellent operating results across the P&L:Year-over-year net product sales grew 17% and adjusted diluted EPS grew 25%Year over year net product sales grew 17% and adjusted diluted EPS grew 25%Improved adjusted operating margins by 180 bps Y/Y; 20 bps Q/Q
Adding value with financial drivers:Adding value with financial drivers:Authorized additional $3 billion in share repurchase programTotal repurchases in Q2 $834M, 6.9M shares; H1:13 $1.84B, 16.3M shares
Strong momentum in metrics including:REVLIMID® year-over-year growth of 13% U S l f REVLIMID® f MCL EU l f MDSU.S. approval for REVLIMID® for MCL; EU approval for MDS
Investing for the future:Entered into additional collaborations addressing new drug targetsExecuting on investment plan for I&I
8
Total Net Product Sales
Q2(Growth Rates = Growth vs. Prior Year Period)
$1,337
$1,564
$1,148*
$ ,
on
↑40% ↑16%$ M
illio
↑17%
Q2:11 Q2:12 Q2:13*Q2:11 adjusted
9
Volume Drove Q2:13 Net Product Sales Growth
Contribution to Q2:13 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
$1 600
$1,800 ↑17%↓2%↑16% ↑3%
$1,200
$1,400
$1,600
on
$600
$800
$1,000
$ M
illio
$200
$400
$600
$0Q2:12 Volume Price Fx / Hedge Q2:13
10
Adjusted Diluted Earnings Per Share
Q2(Growth Rates = Growth vs. Prior Year Period)
$1.52
$0.89
$1.22
r sha
re
↑37%↑29% ↑25%
olla
rs p
erD
Q2:11 Q2:12 Q2:13
11
Adjusted Diluted EPS Growth Driven by Operating Income
Contribution to Q2:13 Adjusted Diluted EPS
$1.52$0.00$0.26$1.22 ($0.01) $0.05
Sha
reol
lars
Per
D
Q2:12 Operating Income Financial Income / Expense
Tax Rate Share Count Q2:13
12
Worldwide Net Product Sales
Net Product Sales ($ million)
Q22013
∆ vs.Q2:12
∆ vs.Q1:13
REVLIMID® Total $1,052 ↑13% ↑5%
U.S. $625 ↑16% ↑10%
International $427 ↑8% ↓2%
VIDAZA® Total $211 ↑5% ↑4%U.S. $84 ↑3% ↓3%
International $127 ↑7% ↑8%International $127 ↑7% ↑8%
ABRAXANE® Total $155 ↑41% ↑26%
U.S. $120 ↑38% ↑28%
International $35 ↑55% ↑21%
POMALYST® Total $66 NA NA
U S $58 NA NAU.S. $58 NA NA
International $8 NA NA
13
Volume Drove Q2:13 REVLIMID®
Net Product Sales Growth
Contribution to Q2:13 REVLIMID® Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
$1,200 ↑12.6%↓2.5%↑11.4% ↑3.7%
$800
$1,000
on
$600
$800
$ M
illio
$200
$400
$0Q2:12 Volume Price Fx / Hedge Q2:13
14
Key P&L Line Items (Adjusted)
Q2 ∆ vs. ∆ vs.Q2013 Q2:12 Q1:13
Product Gross Margins 95.1% ↑30 bps ↑50 bpsProduct Gross Margins 95.1% ↑30 bps ↑50 bps
R&D Expenses% of revenue
$345M21.5% ↓400 bps ↓100 bps
SG&A Expenses% of revenue
$384M24.0% ↑240 bps ↑120 bps
Operating Profit Margin 49.6% ↑180 bps ↑20 bps
Effective Tax Rate 17.1% ↑60 bps ↑60 bps
15
Adjusted Operating Leverage Increased
37.9%41.0%
44.3% 45.1%48.1% 49.5%
28.0%
25.4% 23.4% 22 8% 22.8% 22.0%24.1%
26.0% 25.5% 25.8%23.8% 23.4%
25.4% 23.4% 22.8% 22.8% 22.0%10.6% 8.0% 7.1% 6.5% 5.4% 5.2%
2008 2009 2010 2011 2012 YTD 2013
Operating Margin SG&A R&D COGS
16
Improving ROIC
16%$12
ROIC
12%
14%$10
8%
10%
$6
$8
on
4%
6%$4$
Bill
io
0%
2%
$0
$2 Average Invested Capital
0%$02007 2008 2009 2010 2011 2012 2013
(TTM)
17
GAAP operating income used for all periods except 2008. Refer to reconciliation tables for ROIC calculation methodology
Cash and Marketable Securities
($ billion) 6/30/13 12/31/12($ )
Cash and Marketable Securities $4.08 $3.90
• Cash flow from operations was $737M during Q2• In Q2 2013, purchased 6.9M shares for total cost
$834M • In H1 2013 purchased 16 3M shares for total costIn H1 2013, purchased 16.3M shares for total cost
$1.84B• Authorized additional $3 billion in share repurchase
program
18
2013 Adjusted Guidance Raised
2013 Guidance
∆ vs.2012 Previous
Total Net Product Sales ~$6.2B ↑~15% ~$6B
REVLIMID® Net Product $4 2 4 3B ↑~13% $4 1 4 2BSales $4.2-4.3B ↑~13% $4.1-4.2B
Adjusted Diluted EPS $5.80-$5 90 ↑~19% $5.55-
$5 65
• Key Assumptions
• Share count remains constant with YE:12
j $5.90 ↑ $5.65
Share count remains constant with YE:12
• Adjusted Operating Margins of ~49%
• Range accommodates a possible generic VIDAZA® entry in Q4:13
U i id i t f t l l t th• Using midpoint of range to calculate growth
• Includes investment to build I&I franchise
19
Mark Alles
Q2 Hematology/Oncology Operating Results
Record Net Product Sales:Year-over-year net product sales of $1,564M grew 17% Year-over-year REVLIMID® sales of $1 052M grew 13%Year-over-year REVLIMID sales of $1,052M grew 13%Year-over-year ABRAXANE® sales of $155M grew 41%POMALYST® sales of $66M; H1 2013 sales of $95M
Product Growth Drivers Intact:New clinical data, publications, presence at international meetingsNew indication and product approvals commercial launchesNew indication and product approvals, commercial launchesMarket share and duration of therapy gains, geographic expansion
Significant Franchise Expansion Opportunities:REVLIMID® global approvals for NDMM, novel combinations in multiple myelomaPOMALYST® global approvals for RRMM
21
REVLIMID® CLL and NHL development programsGlobal approvals for ABRAXANE® in pancreatic cancer
Q2 2013 REVLIMID® Results
EuropeUnited States Rest-of-World• Y/Y sales grew 9%
• Strong performance in Germany, Italy, and UK
• EU4 multiple myeloma
• Y/Y sales grew 16%
• Overall multiple myeloma market share consistently in mid 50% range
• Good quarterly sales in Japan, Canada and Australia
• China launch underway; • EU4 multiple myeloma market share (2nd line) consistently above 50% and growing
• Strong duration of
g
• Total prescriptions increased; record number of patients treated
• Increased duration of
y;early results exceed internal expectations
• Achieved public reimbursement in • Strong duration of
therapy gains in France and Italy
• Launching recently approved MDS
• Increased duration of therapy
• Launching RR MCL indication
Mexico; seeking reimbursement in Korea, Russia, and Brazil
approved MDS indication
22
Planned Expansion of REVLIMID® in NDMM: MM-020 Design and Objectives
Trial ArmsPatients
Trial Arms
N = 1,623 N l di d
ARM A: REVLIMID® / low dose dexamethasone continuous therapy
to disease progression• Newly diagnosed
• Transplant-ineligiblemultiple myeloma
to disease progression
ARM B:REVLIMID® / low dose dexamethasone for 18 28-day cycles
R1:1:1
• Stratified by age(65-75 vs. > 75 years), disease stage (ISS I/II vs. III) and country
ARM C: THALOMID® / melphalan / prednisone for 12 42-day cyclescountry prednisone for 12 42-day cycles
• Primary Endpoint: Progression-free survival• Secondary Endpoint: Overall survival
23
Planned Expansion of REVLIMID® in NDMM: MM-020 Design and Objectives
Trial ArmsPatients
Trial Arms
N = 1623 N l di d
ARM A: REVLIMID® / low dose dexamethasone continuous therapy
to disease progressionEnrollment began August 2008• Newly diagnosed
• Transplant-ineligiblemultiple myeloma
to disease progression
ARM B:REVLIMID® / low dose dexamethasone for 18 28-day cycles
R1:1:1
Enrollment began August 2008Enrollment completed in Q1 2011
Achieved Primary Endpoint – Final PFS• Stratified by age(65 - 75 vs. > 75 years) and disease stage (ISS I/II vs. III) ARM C: THALOMID® / melphalan /
prednisone for 12 42-day cycles
Achieved Primary Endpoint Final PFS
prednisone for 12 42-day cycles
• Primary Endpoint: Progression-free survival• Secondary Endpoint: Overall survival
24
REVLIMID® Newly Diagnosed Multiple Myeloma:Phase III Data and Regulatory Update
Trial Relevant PatientP l ti
Possible Timing f M t D t
Possible RegulatoryTrial Population of Mature Data Regulatory Submission Dates
MM-020 NDMM NSCT Elderly
Q3:13(Final PFS)
Q4:13 EUQ4:13 USElderly (Final PFS)
(Interim OS)Q4:13 US
MM-015 NDMM NSCTMaintenance
Q1:13(OS Trend)
Q4:13 EU
< 75 years( )
IFM 2005-02 NDMM SCT Maintenance
H2:14/H1:15(OS Trend)
6 months after availability of data
CALGB 100104
NDMM SCT Maintenance
H2:14/H1:15(OS Trend)
6 months after availability of data
25
REVLIMID® Maintenance Improved PFS and OS in NDMM (GIMEMA)
N=402
Source: Palumbo, et. al, ASCO 2013 and EHA 2013
26
Key REVLIMID® Lymphoma Data from the International Congress on Malignant Lymphoma (ICML) Meeting
CALGB 50803 N=63
• Phase II study of REVLIMID® Plus rituximab in patients with
Dose 20-25 mg
Duration 1 year
rituximab in patients with previously untreated follicular lymphoma (CALGB 50803)
Rituximab 8 doses
Median Age 53 years
FLIPI 0-1 32%
• Multicenter phase II demonstrating R2 produced 93% overall response rate (ORR), >70% PET
FLIPI 2 65%
FLIPI 3-5 3%
ORR 93%
response rate (ORR), 70% PET (–) CR
• Previous phase II (Fowler et al) ORR 93%
CR 72%
PFS Too early
• Previous phase II (Fowler, et al) demonstrated >90% ORR with very high CR rates
Source: Martin, et.al., ICML 2013
27
RELEVANCE® Trial of REVLIMID® plus Rituximab®
in Untreated Follicular Lymphoma
Trial ArmsPatients
Trial Arms
REVLIMID® : 20-mg on D2-22 of a 2-day cycle for up to 18 cycles
Rituximab: 375 mg/m2 D 1 8 15 and 22 of aN = 1,000
R1:1
Rituximab: 375 mg/m2 D 1, 8, 15 and 22 of a 28-day cycle for cycles 2-6, then 375 mg/m2
every 8 weeks for 12 cycles• Histologically confirmed
CD20+ follicular lymphoma grade 1, 2 or 3a
N l di d
Rituximab-CHOP, Rituximab-CVP, Rituximab-Bendamustine followed by 375 mg/m2 Rituximab every 8 weeks for 12 cycles
• Newly diagnosed
• Stage II, III or IV disease
28
• Primary Endpoint: Complete response rate; Progression free survival• Secondary Endpoints: Safety, time to treatment failure, event free survival, time to next anti-
lymphoma treatment, time to next chemotherapy treatment, overall survival, QoL
RELEVANCE® Trial of REVLIMID® plus Rituximab®
in Untreated Follicular Lymphoma
Trial ArmsPatients
Trial Arms
REVLIMID® : 20-mg on D2-22 of a 2-day cycle for up to 18 cycles
Rituximab: 375 mg/m2 D 1 8 15 and 22 of aN = 1,000
R1:1
Rituximab: 375 mg/m2 D 1, 8, 15 and 22 of a 28-day cycle for cycles 2-6, then 375 mg/m2
every 8 weeks for 12 cycles• Histologically confirmed
CD20+ follicular lymphoma grade 1, 2 or 3a
N l di d
Enrollment On Target>35% of Patients Enrolled
Rituximab-CHOP, Rituximab-CVP, Rituximab-Bendamustine followed by 375 mg/m2 Rituximab every 8 weeks for 12 cycles
• Newly diagnosed
• Stage II, III or IV disease Accrual Expected to Complete H2:14
29
• Primary Endpoint: Complete response rate; Progression free survival• Secondary Endpoints: Safety, time to treatment failure, event free survival, time to next anti-
lymphoma treatment, time to next chemotherapy treatment, overall survival, QoL
REMARC® REVLIMID® Maintenance in Diffuse Large B-Cell Lymphoma (DLBCL)
Trial ArmsPatients
Trial Arms
REVLIMID®
N = 621
R1:1
Daily for D1-21 of a 28-day cycleN = 621
• Patients who have received at least 6-8 cycles of the R-CHOP 14 or R-CHOP 21
Placebo
• Stratification by high risk
30
• Primary Endpoint: Progression free survival• Secondary Endpoints: Overall survival, event-free survival, response rate, percentage of patients
who convert from PR (partial response) to CR (complete response), adverse events
REMARC® REVLIMID® Maintenance in Diffuse Large B-Cell Lymphoma (DLBCL)
Trial ArmsPatients
Trial Arms
REVLIMID®
N = 621
R1:1
Daily for D1-21 of a 28-day cycleN = 621
• Patients who have received at least 6-8 cycles of the R-CHOP 14 or R-CHOP 21
Enrollment On Target~75% of Patients Enrolled
Placebo
• Stratification by high riskAccrual expected to complete in Q4:13
31
• Primary Endpoint: Progression free survival• Secondary Endpoints: Overall survival, event-free survival, response rate, percentage of patients
who convert from PR (partial response) to CR (complete response), adverse events
CLL-002 CONTINUUM® Trial of REVLIMID®
Maintenance in Chronic Lymphocytic Leukemia (CLL)
Trial ArmsPatients
Trial Arms
REVLIMID® N = 400
• Treated with a purine
R1:1
Daily until disease progressionp
analog- or bendamustine-containing regimen in the 1st and/or 2nd line induction therapy
Placebo
• Alemtuzumab-containing regimens allowed for those patients with 17p deletion
32
• Primary Endpoint: Overall survival, progression free survival• Secondary Endpoints: Safety, tumor response, duration of response, health related quality of life
CLL-002 CONTINUUM® Trial of REVLIMID®
Maintenance in Chronic Lymphocytic Leukemia (CLL)
Trial ArmsPatients
Trial Arms
REVLIMID® N = 400
• Treated with a purine
R1:1
Daily until disease progressionp
analog- or bendamustine-containing regimen in the 1st and/or 2nd line induction therapy
Enrollment On Target; >60% EnrolledAccrual expected to complete in H2:14
Placebo
• Alemtuzumab-containing regimens allowed for those patients with 17p deletion
Accrual expected to complete in H2:14
33
• Primary Endpoint: Overall survival, progression free survival• Secondary Endpoints: Safety, tumor response, duration of response, health related quality of life
POMALYST®
U.S. Launch Update
• Strong launch momentum continues– Registered prescribers
N ti t t t i ti– New patient starts, prescriptions– Repeat prescriptions– Positive payer and market access awareness– Executing multiple myeloma franchise commercial strategy
• Positive physician and patient clinical experience
• Data presentations at ASCO and EHA updated clinical profile– Long-term OS follow up from MM-002, MM-003, and IFM 0902– Quality of life results– Data in patients with renal Impairment– Data in patients with renal Impairment– Cytogenetically defined high risk disease– Elderly patients– Novel combinations
34
Q2 2013 ABRAXANE® Results
• Q2:13 Net Sales: $155M, ↑41% Y/Y– US ↑38% Y/Y, International ↑55% Y/Y
• Breast Cancer$155
Breast Cancer– US market share stable; gains in
Germany, Italy and Spain– Initiating Triple Negative Breast Cancer
study$106 $106
$123
study
• NSCLC– Continued US market share gains in
overall and squamous histologyI iti ti i t t d i lio
ns
Int'lUS
– Initiating maintenance study in squamous NSCLC
• Pancreatic Cancer– World GI Symposium presentations
$ M
ill– Advancing adjuvant phase III study– PDUFA date September 21, 2013
• Other Tumor Types Q3:12 Q4:12 Q1:13 Q2:13– Melanoma phase III study expect mature
overall survival results by Q4:13
35
Generating Strong Franchise Momentum
Our Offer significant value propositions OurProducts • Improved clinical outcomes
• Excellent global market access
OurPerformance
Focused on operational excellence• 2013 net product sales of approximately $6.2B
N li i l d t i di ti d d t l• New clinical data, new indication and product approvals
OurOutlook
Long growth runway with multiple drivers• Meaningful catalysts for growth in multiple myeloma,
MDS, NHL, CLL, and oncology
36
Scott Smith
Rapid Succession of Approvals Expected Through 2014 and Beyond
S b it
On Track
S b it I l t
Submit Australia and Switzerland PSOR/PsA
S b it
Submit EU MAA AS
PDUFA DateMarch 21
Submit EU Approval
Submit Canada
PSOR NDS
Approval Approval Approval
Implement next tier
registrations
Submit US AS NDA
Submit CanadaAS NDS
Approval US AS
March 21, 2014
Submit US PsA NDA
Submit EU PsA/PSOR
MAA
Submit USPSOR NDA
Approval US PsA
Approval US PSOR
Submit Canada
PsA NDS
Approval Canada
PsA
Approval CanadaPSOR
ApprovalEU
PsA/PSOR
Q1Q1 Q2Q2 H1H1 H2H2 H1H1H2H2
2013 2014E 2015E2013 2014E 2015E
38
• Exploring opportunities to file Behçet’s
PALACE Program: Consistent Response Rate that Improves over Time
ACR 20 t W k 16ACR 20 t W k 16 PALACE 1 52 WeeksPALACE 1 52 Weeks
60
70
43 §
PALACE 1 PALACE 3
ACR 20 at Week 16ACR 20 at Week 16
60
70
80
PALACE 1 52 WeeksPALACE 1 52 Weeks
g %)
Apremilast 20 mg BID Apremilast 30 mg BID
20
30
40
50Subjects Achieving
ACR20(%)
19
31*
41§
24
29*
43 §
30
40
50
Patie
nts
Ach
ievi
ngC
R20
Res
pons
e (%
* §P 0 05 P 0 0001
0
10
165 163 161 164 163 159n=
Placebo Apremilast 20 mg BID Apremilast 30 mg BID
0
10
20
16 24 40 52
P AC
Study Week Data as observed* §P>0.05; P>0.0001. LOCF, Per Protocol Populationy Data as observed
Source: Edwards, et.al., EULAR 2013 Source: Kavanaugh, et.al., EULAR 2013
39
BCT 001: Signficant Oral Ulcer Response
Mean Number of Oral UlcersMean Number of Oral Ulcers
3 5
Oral Ulcer Response at Day 85Oral Ulcer Response at Day 85
2 0
2.5
3.0
3.5
70.9*
89.1*
80
100
(%)
Mean # of Oral Ulcers
0 5
1.0
1.5
2.0
28.6
50
40
60(%)
Patients Achieving Complete or Partial Oral Ulcer Response
wk0
wk2
wk4
wk6
wk8
wk10
wk12
wk14
wk16
wk18
wk20
wk22
wk24
wk26
wk28
Placebo 2.9 1.7 1.9 1.9 1.6 1.4 2.1 0.4 0.4 0.6 0.5 0.3 0.4 1.3 1.630 mg BID 2.7 0.3 0.7 0.5 0.5 0.7 0.5 0.6 0.6 0.6 0.7 0.2 0.6 1.9 1.7
0.0
0.5
0
20
Complete Response Partial Response
Placebo Apremilast 30 mg BID*P<0.0001Placebo Apremilast 30 mg BID
*P<0.0001
Source: Hatemi, et.al., EULAR 2013
40
Robust Data Rollout at Medical Meetings
Data Release AnticipatedData Release AnticipatedppH2 2013H2 2013
PALACE Program (1-3)• PALACE 2 full data• PALACE 3 52-week update• Enthesitis/dactylitis data• Pooled metabolic/lab data
Behçet’s Disease Phase II DetailsESTEEM 1• Difficult-to-treat patient subsets
( l d il )(scalp and nails)• Patient reported outcomes• Safety data
41
I&I: Transformational Potential for Patients and for Celgene
Apremilast• Positive efficacy data in two psoriasis and four
psoriatic arthritis trials
Potential to createa new gold standard
for treatment of
• Differentiated safety profile and well tolerated across studied patient populations
• Unique benefit risk profile for treatment of
psoriatic disease as well as other serious
immunologicdiseases
• Emerging profile supports significant opportunity across multiple segments of the market
• Lifecycle management underway diseasesLifecycle management underway
• Submissions on track
• Key management positions filled
• Launch activities accelerating• Launch activities accelerating
Robust pipeline under development
42
Bob Hugin
Key Milestones – 2013
Product Milestone Expected Timing
Phase III MM-020 data in NDMM Q2:13 / Q3:13
US decision for mantle cell lymphoma Q2:13US decision for mantle cell lymphoma Q2:13
• Resubmission of the NDMM application in EU H2:13
• Submit for approval in the US in NDMM H2:13
• Approvals and reimbursement for RRMM in emerging markets Throughout 2013
US Regulatory decision for RRMM Q1:13
• EU Regulatory decision for RRMM Q3:13
× Phase III myelofibrosis data H1:13
Submit regulatory applications for pancreatic cancer in US & EU H1:13
• Mature phase III overall survival data in melanoma H2:13
• FDA decision for pancreatic cancer Q3:13
Phase III ESTEEM data in psoriasis Q1:13Phase III ESTEEM data in psoriasis Q1:13
• Submit for approval in psoriatic arthritis and psoriasis US; ROW Throughout 2013
Phase III data in treatment-naïve psoriatic arthritis H1:13
• Complete enrollment in Phase III ankylosing spondylitis trial H2:13
44
Q2 2013 Conference CallJuly 25, 2013
Reconciliation Tables
Reconciliation Tables
Net product salesOther revenue
Total revenue
Cost of goods sold (excl uacquired intangible a
Research and developmeSelling, general and adminAmortization of acquired Acquisition related charg
Total costs and exp e
Operating income
Other income (expense),
Income before income ta
Income tax provision
Net income
Net income per common BasicDiluted
Weighted average shares
BasicDiluted
Balance sheet items:Cash, cash equivaleTotal assetsShort-term borrowi nLong-term debtTotal stockholders' e uding amortization of
assets)entnistrative
intangible assetses and restructuring, netenses
net
axesshare:
s:nts & marketable securities
ngsequity
CelgCondens
20
$
$
$ $
Ju n20
s$ 1
gene Corporation ansed Consolidated Sta
(Unaudited)(In millions, except per
Thre0132012
1,564.1
1,336.6$
34.9
30.2
1,599.01,366.8
80.9
71.9
458.1
447.2
418.1
323.0
65.7
44.1
12.5
39.3
1,035.3925.5
563.7
441.3
(5.9)
(0.6)
557.8
440.7
79.7
73.3
478.1
367.4$
1.15
0.84$
1.11
0.82$
414.1
436.7
429.3
445.4
ne 30,December 31,
0132012
4,081.4
3,900.3$
11,963.711,734.3
887.8
308.5
2,730.4
2,771.3
5,407.15,694.5
nd Subsidiariesatements of Income
share data)
ee-Month Periods EndedJune 30,
20132,993.4$
$ 70.2
3,063.6
161.4
910.5
787.1
131.4
45.7
2,036.1
1,027.5
(21.3)
1,006.2
143.2
863.0$
$
2.07$
$ 2.00
$ $
416.0
431.0
Six-Month Peri oJune 30
47
20122,582.1
58.0
2,640.1 144.4 809.2 648.8 85.9 28.2
1,716.5 923.6 (8.9) 914.7 145.8 768.9 1.76 1.72 437.5 447.1
ods Ended0,
Reconciliation Tables
Net income - GAAP
Before tax adjustm Cost of goods so of acquired inta Products exite Share-based c
Research and de Share-based c IPR&D impai Upfront collab
Selling, general a Share-based c
Amortization of a
Acquisition relate Change in fair Acquisition an
Net income tax adNet income - Adjusted
Net income per commoBasicDiluted
In addition to financiameasures that we belietrends that facilitate cand should be considetypically exclude certadefinition of unusual ments:
old (excluding amortizationangible assets):ed or to be exited -Pharmiocompensation expense
evelopment:compensation expenseirmentsboration payments
and administrative:compensation expense
acquired intangible assets
ed charges and restructurinr value of contingent considnd restructuring costs
djustmentsdon share - Adjusted
CeReconc
al information prepared ieve provide investors and
comparisons between periered in addition to, but nain GAAP items that manaor non-recurring items. O
$
on(1)
(2)
(2)
(3)
(4)
(2)
(5)
ng, net:deration
(6)
(6)
(7) $
$ $ T
elgene Corporationciliation of GAAP to
(In millions, except p
in accordance with U.S. Gd management with suppliods and with respect to pot as a substitute for, theagement does not believeOther companies may def 2013
2012
478.1
367$
-
(0
3.7
3
31.8
23
-
-
81.8
75
34.3
27
65.7
44
12.5
38
-
1
(55.0)
(34
652.9
54 4$
1.58
1.$
1.52
1 .$
Three-Month Periods Ended
n and Subsidiarieso Adjusted Net Incoper share data)
June 30,
GAAP, this press release lemental information relaprojected information. Th
e information prepared ine affect our basic operatiofine these measures in diff
2013
7.4863.0
$
0.6)-
3.0
6.5
3.658.8
-
-
5.0177.5
7.170.1
4.1131.4
8.145.7
1.2
-
4.3)(108.4)
4.6
1,244.6$
.252.99
$ .22
2.89$
dSix-Month P
ome
Jun
also contains adjusted fiting to operating perform
hese adjusted measures an accordance with U.S. GAons and that do not meet
fferent ways.
48
2012768.9$ (2.0) 5.9 48.6 22.2 75.0 53.9 85.9 25.6 2.6 (57.6) 1,029.0$
2.35$ 2.30$
Periods Endedne 30,
inancial mance and are non-GAAP
GAAP. We the GAAP
Reconciliation Tables
Explanation of adjustments:(1) Exclude the net (benefit) cost of activities arising from the acquisition of Pharmion Corp. (Pharmion) that are planned to be exited.(2) Exclude share-based compensation expense totaling $69.8 for the three-month period ended June 30, 2013 and $53.7 for the
three-month period ended June 30, 2012. Exclude share-based compensation expense totaling $135.4 for the six-month period endedJ 30 2013 d $108 4 f th i th i d d d J 30 2012 June 30, 2013 and $108.4 for the six-month period ended June 30, 2012.
(3) Exclude in-process research and development impairments recorded as a result of changes in estimated probability-weighted cash flows.(4) Exclude upfront payments for research and development collaboration arrangements.(5) Exclude amortization of intangible assets acquired in the acquisitions of Pharmion, Gloucester Pharmaceuticals, Inc. (Gloucester),
Abraxis BioScience Inc. (Abraxis) and Celgene Avilomics Research, Inc. (formerly known as Avila Therapeutics)(Avila).(6) Exclude acquisition related charges and restructuring including changes in the fair value of contingent consideration related to the(6) Exclude acquisition related charges and restructuring, including changes in the fair value of contingent consideration, related to the
acquisitions of Gloucester, Abraxis and Avila.(7) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating
tax adjustments, including one-time effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits and deferred taxes on unremitted foreign earnings.
49
Reconciliation Tables
Projected net income -
Before tax adjust Cost of goods so of acquired int Share-based
Research and d Share-based Upfront coll a
Selling, general Share-based
Amortization of
Acquisition rela t Change in fai
Net income tax a
Projected net income -
Projected net income p
Projected net income p
Projected weighted av
(1)Our projected ear intangible asset occur after the d
Reconciliation o- GAAP
tments:old (excluding amortizationtangible assets):compensation expense
development:compensation expense
aboration payments
and administrative:compensation expense
facquired intangible assets
ted charges and restructurir value of contingent cons
adjustments
- Adjusted
per diluted common share
per diluted common share
verage diluted shares
rnings do not include the eimpairments, or changes i
date of this press release.
Celgene Corporof Full-Year 2013 P
(In millions
(1)$
n
s
ring, net:sideration
$
- GAAP$
- Adjusted$
effect of any business comin the fair value of our CV
ration and SubsidiaProjected GAAP to, except per share data)
LowHig
1,792.8$
1$
12.6
123.2
267.5
163.9
265.4
63.0
(194.4)
2,494.0$
2$
4.17$
$
5.80$
$
430.0
mbinations, collaboration aVRs issued as part of the a
Range
arieso Adjusted Net Incgh1,855.0
12.2 118.4 267.5 157.5 262.8 63.0 (199.4) 2,537.0
4.31 5.90 430.0 greements, asset acquisit iacquisition of Abraxis that
come
50
ions, t may
Return on Invested Capital Calculation
Return on Invested Capital (ROIC)Return on Invested Capital (ROIC)2013 (TTM) 2012 2011 2010 2009 2008
Operating income 1,850,332 1,746,442 1,442,753 989,635 841,526 (1,464,218) Certain charges (1) 2,043,069
Operating income (non-GAAP for 2008) 1,850,332 1,746,442 1,442,753 989,635 841,526 578,851
Effective tax rate 13% 13% 7% 13% 20% 24%Effective tax rate 13% 13% 7% 13% 20% 24%Operating income after tax (non-GAAP for 2008) 1,617,883 1,512,428 1,339,017 860,221 669,930 439,272
Total equity 5,407,102 5,694,467 5,512,727 5,995,472 4,394,606 3,491,328 Certain charges (1) 1,979,510 1,979,510 1,979,510 1,979,510 1,979,510 1,979,510 Total debt 3,618,161 3,079,792 1,802,269 1,247,584 - -
Total capital 11,004,773 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838Total capital 11,004,773 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838
Total capital beginning of period 9,600,085 9,294,506 9,222,566 6,374,116 5,470,838 3,040,499 Total capital end of period 11,004,773 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838
Average total capital 10,302,429 10,024,138 9,258,536 7,798,341 5,922,477 4,255,669
ROIC 15.7% 15.1% 14.5% 11.0% 11.31% 10.3%O C 5 % 5 % 5% 0% 3 % 0 3%
(1) Excludes $1.7 billion of IPR&D expense in 2008 associated with the acquisition of Pharmion, as well as $300 millionof expense related to the acquisition of intellectual property rights for Vidaza in 2008 prior to it's launch. Amounts adjustedfor tax effects in 2008 are excluded from equity in all years including and subsequent to 2008.
51
Appendix
Celgene Pipeline
53
Celgene Pipeline
54
Celgene Pipeline
55
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population NDMM Non-ASCT Eligible NDMM Non-ASCT Eligible
Trial Name MM-015MM-020FIRST®
Phase III III
Target Enrollment 459 1,623
D i
Arm A: REVLIMID® (10mg), melphalan, prednisone for 9 cycles followed by :
REVLIMID® (10mg) maintenance to disease progression
Arm B: : REVLIMID® (10mg) melphalan
Arm A: : REVLIMID®/low-dose dexamethasone until disease progression
Arm B: : REVLIMID®/low-dose d th f 18 4 k lDesign Arm B: : REVLIMID (10mg), melphalan,
prednisone for 9 cycles followed by placebo maintenance to disease progression
Arm C: Melphalan/prednisone for 9 cycles followed by placebo maintenance to disease
progression
dexamethasone for 18 4-week cyclesArm C:
THALOMID®/melphalan/prednisone for 12 6-week cycles
Primary Endpoint Progression Free Survival Progression Free Survival
Study met primary endpoint July 2009Data presented at ASH 2009 with follow-up d t t ASCO 2010 ASH d IMW 2011
Enrollment completeStatus data at ASCO 2010, ASH and IMW 2011,
ASH 2012 and IMW 2013. Published in NEJM May 2012
Follow-up continuing
Trial met primary endpoint for PFSData presentation expected at ASH 2013
56
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance Post-ASCT Maintenance Post-ASCT
Trial Name CALGB 100104 IFM 2005-02Trial Name CALGB 100104 IFM 2005-02
Phase III III
Target Enrollment 459 614
Arm A: Single agent : REVLIMID® (10mg)Arm A: : REVLIMID®consolidation (25mg) for 2 cycles followed by REVLIMID® (10-
15mg) until disease progressionDesign until disease progression
Arm B: Placebo until disease progression
15mg) until disease progressionArm B: : REVLIMID®consolidation (25mg)
for 2 cycles followed by placebo until disease progression
P i E d i t Ti t P i P i F S i lPrimary Endpoint Time to Progression Progression Free Survival
Status
Trial met primary endpoint in Dec 2009Data presented at ASCO 2010. Follow-up data at ASH 2010, IMW 2011 and IMW
2013
Trial met primary endpoint in June 2010Data presented at ASCO 2010. Follow-up data at ASH 2010 and IMW 2011.Status 2013.
Published in NEJM May 2012.Follow-up for survival continuing
pPublished in NEJM May 2012.
Follow-up for survival continuing
57
POMALYST® Multiple Myeloma Late Stage Programs
Patient Population RRMM (3rd Line +) RRMM
Trial NameMM-003 MM-007
Trial NameNIMBUS OPTIMISMM
Phase III III
Target Enrollment 426 782
Arm A: POMALYST® (4mg) and low- Arm A: POMALYST® (4mg), bortezomib (1.3
Design
Arm A: POMALYST (4mg) and lowdose dexamethasone to disease
progressionArm B: High-dose dexamethasone to
disease progression
Arm A: POMALYST (4mg), bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to
disease progressionArm B: Bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to disease progression
Primary Endpoint Progression Free SurvivalProgression Free Survival
Primary endpoint met Dec 2012Status
Primary endpoint met Dec 2012Data presented at ASH 2012 and ASCO
2013Trial enrolling
58
POMALYST® Multiple Myeloma Late Stage Programs
Patient Population RRMM
T i l N MM-010Trial Name MM 010STRATUS
Phase IIIb
Target Enrollment 507
DesignPOMALYST® (4mg), bortezomib (1.3
mg/m2 IV) and low-dose dexamethasone to disease progression
Primary Endpoint Adverse Events
Status Trial enrolling
59
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® (Oral Azacitidine)
Trial Name MDS-005 AZA-MDS-003
Phase III III
Target Enrollment 228 386
DesignArm A: REVLIMID® (10mg)
Arm B: PlaceboArm A: CC-486 (150- or 200-mg)
Arm B: Placebo
Primary Endpoint RBC-transfusion independencefor at least 8 weeks
RBC-transfusion independence formore than 12 weeks
Status Trial enrolling Trial enrolling
60
MDS/AML/MF Late Stage Programs
Patient Population Elderly Newly Diagnosed AML Post induction AML Maintenance
MoleculeVIDAZA®
(azacitidine)CC-486
(oral azacitidine)(azacitidine) (oral azacitidine)
Trial Name AZA-AML-001 CC-486-AML-001
Phase III III
Target Enrollment 480 460Target Enrollment 480 460
Arm A: VIDAZA®
(75 mg/m2 SC) daily for D1-7 28-day cycleuntil disease progression
A B C ti l C R i t A A CC 486 (150 200 )Design
Arm B: Conventional Care Regimen to disease progression
Intensive chemotherapy Low-dose cytarabineBest Supportive Care
Arm A: CC-486 (150- or 200-mg)Arm B: Best Supportive Care
Best Supportive Care
Primary Endpoint Overall Survival Overall Survival
StatusEnrollment complete
Trial not open to enrollmentStatusTop-line data in early 2014(E)
Trial not open to enrollment
61
MDS/AML/MF Late Stage Programs
Patient Population
Myeloproliferative-Neoplasm-Associated
Myelofibrosis
Molecule POMALYST®Molecule POMALYST®
Trial Name RESUME (MF-002)
Phase III
Target Enrollment 210
DesignArm A: POMALYST® 0.5mg
dailyArm B: Placebo
Primary Endpoint
Proportion of subjects achieving RBC-transfusion-
independence
Trial did not meet primary
StatusTrial did not meet primary
endpointData to be submitted to a future
meeting
62
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
Target Enrollment 428 400
Arm A: REVLIMID® (starting dosage A A REVLIMID® ( t ti d
Design
(sta t g dosage5mg/day escalated to 10mg/day) until
disease progression. 28-day cycleArm B: Chlorambucil (0.8 mg/kg) D1-15 of 28-day cycle for ~13 cycles (12 months)
Arm A: REVLIMID® (starting dosage 2.5mg/day escalated to 10mg/day) until
disease progression. 28-day cycleArm B: Placebo
Primary Endpoint Progression Free Survival Overall Survival and Progression-Free Survival
Enrollment completed in Q1:13Status
Enrollment completed in Q1:13Trial put on clinical hold in July 2013
Data being analyzed
Trial enrollingEnrollment complete in H2:14(E)
63
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 20m) D2 22 of 28 da c cle for p to 18 c cles
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 of 28-day cycle for up to 18 cycles and rituximab (starting dose 375 mg/m2
weekly) for up to 12 cyclesArm B: Physician’s choice of rituximab-
CHOP, rituximab-CVP or rituximab-bendamustinebendamustine
Primary Endpoint Progression Free Survival Complete response rate and Progression Free Survival
64
StatusTrial enrolling
Enrollment complete in Q4:13(E)Trial enrolling
Enrollment complete in H2:14(E)
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population Metastatic Malignant Melanoma Metastatic Adenocarcinoma of the Pancreas
Trial Name CA033MPACT
Trial Name CA033CA046
Phase III III
Target Enrollment 514 842
Arm A: ABRAXANE® (150 mg/m2) D 1, 8,Arm A: ABRAXANE® (125 mg/m2) and gemcitabine (1000 mg/m2) weekly for 3
Design
Arm A: ABRAXANE (150 mg/m2) D 1, 8, and 15 of a 28-day cycle
Arm B: Cacarbazine (1000 mg/m2) D 1 with steroid and antiemetic of a 21-day
cycle
gemcitabine (1000 mg/m2) weekly for 3 weeks of a 4 week cycle
Arm B: Gemcitabine (1000 mg/m2) weekly for 7 weeks of an 8 week cycle(Cycle 1); Weekly for 3 weeks of a 4
week cycles (Cycle 2+)
Primary Endpoint Progression Free Survival Overall Survival
Efficacy/safety data presented at Society f M l
Primary endpoint met
65
Statusof Melanoma
Research Meeting in November 2012Mature OS data expected in 2013
Efficacy/safety data presented at ASCO GI in January 2013
Regulatory submissions in US and EU
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population First-Line Triple Negative Metastatic Breast Cancer
Trial NametnAcity™
Trial NameABI-007-MBC-001
Phase II/III
Target Enrollment 240-350
Design
Phase IIArm A: ABRAXANE® 125mg/m2,/Gemcitabine 1000 mg/m2, d 1 and 8 – 21-day cycle
Arm B: ABRAXANE® 125mg/m2/Carboplatin AUC 2 IV, d 1 and 8 – 21-day cycleArm C: Gemcitabine 1000 mg/m2/Carboplatin AUC 2 IV, d 1 and 8 – 21-day cycleg g y y
Phase IIIArm 1: Selected phase II ABRAXANE® arm
Arm 2: Gemcitabine 1000 mg/m2/Carboplatin AUC 2 IV, d 1 and 8 – 21-day cycle
Primary Endpoint Progression Free Survival
Status Enrolling Soon
66
I&I Late Stage Programs
Patient Population
Moderate-to-SevereLate Stage Psoriatic
ArthritisModerate-to-Severe Late Stage Psoriatic Arthritis
Moderate-to-Severe Late Stage Psoriatic Arthritis
with Skin Lesions
M l l A il t A il t A il tMolecule Apremilast Apremilast Apremilast
Trial NamePALACE-1PSA-002
PALACE-2PSA-003
PALACE-3PSA-004
Phase III III III
Target Enrollment 495 495 495
Design
Arm A: Apremilast (20mg)twice daily
Arm B: Apremilast (30mg) twice daily
Arm C: Placebo
Arm A: Apremilast (20mg)twice daily
Arm B: Apremilast (30mg) twice daily
Arm C: Placebo
Arm A: Apremilast (20mg)twice daily
Arm B: Apremilast (30mg)twice daily
Arm C: Placebo
Primary Endpoint ACR20 ACR20 ACR20
Enrollment completeEffi / f t d t
Enrollment completeEnrollment complete
StatusEfficacy/safety data presented at ACR in
November 2012 and EULAR 2013
Top-line data in Sept 2012Efficacy/safety to be presented in 2013
Enrollment completeEfficacy/safety to bepresented in 2013
67
I&I Late Stage Programs
Patient Population
Treatment Naïve Moderate-to-SevereLate Stage Psoriatic
Arthritis
Moderate-to-SeverePlaque Psoriasis
Moderate-to-Severe Plaque Psoriasis
Molecule Apremilast Apremilast Apremilast
Trial NamePALACE-4PSA-005
ESTEEM-1PSOR-008
ESTEEM-2PSOR-009
Phase III III III
Target Enrollment 495 825 825
Design
Arm A: Apremilast (20mg)twice daily
Arm B: Apremilast (30mg) twice daily
A C Pl b
Arm A: Apremilast (30mg) twice daily
Arm B: Placebo
Arm A: Apremilast (30mg)twice daily
Arm B: PlaceboArm C: Placebo
Primary Endpoint ACR20 PASI-75 PASI-75
Enrollment complete Enrollment complete Enrollment completeStatus
Enrollment completeEfficacy/safety to be presented in 2013
Enrollment completeEfficacy/safety data presented
at AAD in March 2013
Enrollment completeEfficacy/safety data to be
presented in 2013
68
I&I Late Stage Programs
Patient Population Moderate-to-Severe Plaque Psoriasis Ankylosing Spondylitis
Molecule Apremilast ApremilastMolecule Apremilast Apremilast
Trial Name PSOR-010POSTURE
AS-001
Ph IIIb IIIPhase IIIb III
Target Enrollment 240 456
Design
Arm A: Apremilast (30 mg) twice dailyArm B: Etanercept (50 mg subcutaneous)
once weeklyArm C: Placebo
Arm A: Apremilast (20mg) twice dailyArm B: Apremilast (30mg) twice daily
Arm C: Placebo
Primary Endpoint PASI75 ASAS20
Trial enrollingStatus Trial enrolling
Trial enrollingEnrollment complete in H2:13(E)
Top line data expected in 2014
69