Post on 20-May-2020
Q2 2016 Conference CallJuly 28, 2016
Q2 2016 Earnings Call
Mark Alles, Chief Executive Officer
Peter Kellogg, Chief Financial Officer
Michael Pehl, President, Hematology & Oncology
Q&A
Scott Smith, President, Global I&I
Jackie Fouse, President & Chief Operating Officer
2
Forward 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” and similarexpressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speakonly as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information orfuture events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which aredifficult 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 onForm 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 that we believe provide investors and management with supplemental information relating to operating performance and trendsthat facilitate comparisons between periods and with respect to projected information. These adjusted measures are non-GAAP andshould be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typicallyexclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition ofunusual or non-recurring items. Other companies may define these measures in different ways. Further information relevant to theinterpretation of adjusted financial measures, and reconciliations of these adjusted financial measures to the most comparable GAAPmeasures, may be found on our website at www.Celgene.com in the “Investor Relations” section.
3
Mark Alles
Q2 2016: Accelerating Momentum; Investing for Our Future
5
Exceptional top-line and bottom-line growth reflects strength and leverage of business model Updating 2016 net product sales (~$11B) and adjusted diluted EPS guidance ($5.70 - $5.75)
Delivering Operational ExcellenceDelivering Operational Excellence
Maximizing the global potential of OTEZLA®
Advancing key pipeline programs, including GED-0301 and ozanimod
Building a Leading I&I FranchiseBuilding a Leading I&I Franchise
Growth driven by strong volume and market dynamics across entire portfolio Late-stage clinical programs position core products for continued growth
Capitalizing on Our Strength in Hematology & Oncology Capitalizing on Our Strength in Hematology & Oncology
Added high potential immuno-oncology partnerships with Jounce and Agios 2017 and 2020 financial targets on-track
Driving Innovation & Long Term Growth Driving Innovation & Long Term Growth
Peter Kellogg
Strong product growth across all franchises Continue to invest in R&D to advance the pipeline
Exceptional Q2 2016 Operating Results
7
Q2:16 year-over-year net product sales grew 22% and adjusted diluted EPS grew 17% Adjusted operating margins improved by 330 bps
Financial HighlightsFinancial Highlights
Excellent Performance on Operating MetricsExcellent Performance on Operating Metrics
2016 adjusted diluted EPS raised from $5.60-$5.70 to $5.70-$5.75 REVLIMID® net product sales and total net product sales guidance updated
2016 Guidance Updated2016 Guidance Updated
Total Net Product Sales(Growth Rates = Growth vs. Prior Year Period)
Q2:14 Q2:15 Q2:16
$1,845
$2,254
$2,745
8
$ M
illio
ns
↑18% ↑22% ↑22%
Volume Drove Q2 2016 Net Product Sales Growth
$0
$500
$1,000
$1,500
$2,000
$2,500
Q2:15 Volume Price Fx / Hedge Q2:16
9
Contribution to Q2:16 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
↑21.8%↓0.7%↑16.1% ↑6.4%
Mill
ions
Adjusted Diluted Earnings Per Share(Growth Rate = Growth vs. Prior Year Period)
$0.90
$1.23
$1.44
Q2:14 Q2:15 Q2:16
10
↑18% ↑37%Dol
lars
Per
Sha
re
↑17%
Q2:16 ∆ vs.Q2:15
∆ vs.Q1:16
Product Gross Margin 96.3% ↑40 bps ↑20 bps
R&D expenses% of revenue
$601M21.8% ↑90 bps ↓170 bps
SG&A expenses% of revenue
$547M19.9% ↓380 bps ↑130 bps
Operating Margin 54.6% ↑330 bps ↑60 bps
Effective Tax Rate 16.3% ↓40 bps ↓30 bps
Key P&L Line Items (Adjusted)
11
Q2 2016 Adjusted Diluted EPS Growth Driven by Increased Adjusted Operating Income
Q2:15 Operating Income
Financial Income / Expense
Tax Rate Share Count Q2:16
12
Dol
lars
Per
Sha
re
$1.44$0.35$1.23 ($0.02) $0.04
Contribution to Q2:16 Adjusted Diluted EPS
($0.16)
Cash and Marketable Securities
• Cash flow from operations was approximately $936M during Q2:16• In Q2:16, purchased $343M of shares; In H1:16, purchased $1.8B
of shares• Authorized additional $3B for share repurchases• $5.1B remaining under stock repurchase program at 6/30/16
13
(in Billions) 6/30/16 12/31/15
Cash and Marketable Securities $6.40 $6.55
Previous 2016 Guidance
Updated 2016 Guidance
REVLIMID® $6.7B ~$6.8B
POMALYST® $1.0B+ Unchanged
ABRAXANE® $950M-$1.0B Unchanged
OTEZLA® $1.0B+ Unchanged
Total Net Product Sales $10.75B - $11.0B ~$11.0B
Adjusted Operating Margin ~53.5% ~54.0%
Adjusted Diluted EPS $5.60 - $5.70 $5.70 - $5.75
Share Count 811M 806M
Updating 2016 Guidance
14
Michael Pehl
Q2 2016 Hematology & Oncology Franchise Results
16
– Q2:16 net sales growth of +16% Y/Y; +9% Q/Q– Advancing market leading positions in myeloma, myeloid disease and pancreatic cancer
Strong Net Product Sales and Franchise Operating MomentumStrong Net Product Sales and Franchise Operating Momentum
– NDMM share and duration increasing globally– POMALYST® U.S. label update for renal impairment data; IMNOVID® EU approval expected in Q3:16– ABRAXANE® performance stable with near-term growth potential in launch markets outside of the U.S.
2016 Product Growth Drivers On-Track2016 Product Growth Drivers On-Track
– AG-221 and luspatercept pivotal programs enrolling– New trials in the FUSIONTM program open; total of six trials enrolling– I/O programs with Juno’s CD19 and bluebird bio’s BCMA advancing– Next generation CELMoD® programs moving forward in the clinic
Long-term Growth Drivers AdvanceLong-term Growth Drivers Advance
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
Q2 2016 REVLIMID® Net Sales Summary
17
• Q2:16 net sales $1,701M; +18% Y/Y (+19% Y/Y excluding negative F/X); +8% Q/Q
• 2016 Growth Drivers REVLIMID® strong duration and share trends globally NDMM launch momentum in U.S. and EU launch
countries EU NDMM reimbursement Japan NDMM launch off to a positive start
• Future Growth Drivers– Triplet combinations further enhancing value proposition
and treatment duration– REVLIMID® maintenance post-ASCT submitted in EU;
U.S. submission in H2:16– Lymphoma program continues to advance
$625 $716$873
$1,080
$427 $498
$571
$621
Q2:13 Q2:14 Q2:15 Q2:16
US ROW
Net Sales ($M)
$1,052
$1,214
$1,444
$1,701
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016
Global REVLIMID® Multiple Myeloma Momentum and Opportunity Continues to Grow
Vd control arms from ENDEAVOR/PANORAMA
Vd control arms from ENDEAVOR/PANORAMA
ASH 2015 and SWOG data release
ASH 2015 and SWOG data release
Updated mSMART & NCCN Guidelines
Updated mSMART & NCCN Guidelines
Rd approval in ndMM
Rd approval in ndMM
Ph III Rd+X readouts and FDA approvals
Ph III Rd+X readouts and FDA approvals
Rd+X clinical experience, later line market expansion
REVLIMID® re-challenge
Rd+X clinical experience, later line market expansion
REVLIMID® re-challenge
18
Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016
Global REVLIMID® Multiple Myeloma Momentum and Opportunity Continues to Grow
Vd control arms from ENDEAVOR/PANORAMA
Vd control arms from ENDEAVOR/PANORAMA
ASH 2015 and SWOG data release
ASH 2015 and SWOG data release
Updated mSMART & NCCN Guidelines
Updated mSMART & NCCN Guidelines
Rd approval in ndMM
Rd approval in ndMM
Ph III Rd+X readouts and FDA approvals
Ph III Rd+X readouts and FDA approvals
Rd+X clinical experience, later line market expansion
REVLIMID® re-challenge
Rd+X clinical experience, later line market expansion
REVLIMID® re-challenge
19
Rd+Dara POLLUX, REVLIMID®
Post-ASCT Maintenance US & EU Submissions
Rd+Dara POLLUX, REVLIMID®
Post-ASCT Maintenance US & EU Submissions
Additional Phase III Lymphoma Trials Reading Out to 2020
20
2016 2017 2018 2019 20201. Reddy N et al, ASH 2015 #2739; Ferreri A et al, ASH 2015 #15472. Kimby, ASCO 2015 #799; Tuscano, ASCO 2015 #4477; Fowler, Lancet Oncol. 2014 Nov;15(12):1311-8; Martin, ASCO 2014, #85213. Leonard, J Clin Oncol. 2015 Nov 1;33(31):3635-40; Tuscano, Br J Haematol. 2014 May;165(3):375-814. Nowakoswki, G; J Clin Oncol. 2015 Jan 20;33(3):251-7; Nowakowski, G. Future Oncology 2016
3 4
Rev + Rit vs Rit in R/R indolent NHL
Rev maintenanceafter 1st LineDLBCL Tx.
Rev+ Rit vs R-CHEMO1st Line indolent NHL
2
1
R2-CHOP vs R-CHOPin 1st Line
ABC DLBCL
3
Rev + Rit vs Rit followed by maintenance in R/R indolent NHL
Footnote: Rev: REVLIMID®, Rit: rituximab, R2:REVLIMID®+rituximab
Q2 2016 POMALYST®/IMNOVID® Net Sales Summary
21
$58$104
$144$185$8
$57
$91
$133
Q2:13 Q2:14 Q2:15 Q2:16
US ROW
$66
$161
$235
$318Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q2:16 net sales $318M; +35% Y/Y (+34% Y/Y excluding positive F/X); +16% Q/Q
• Global launch continues – Global demand continues to grow from volume and
duration• 2016 Growth Drivers
Japan launch exceeding expectations and quickly attained leadership position in 3rd line+ MM
Market share continues to increase in reimbursed markets in Europe
Duration increasing across geographies• Future Growth Drivers
Renal impairment data and label update in U.S. in June; EU label update expected in Q3:16
Research on POMALYST®/IMNOVID® combinations with other novel agents advancing
Net Sales ($M)
Q2 2016 ABRAXANE® Net Sales Summary
22
$120 $160 $170 $175
$35
$55 $74 $74
Q2:13 Q2:14 Q2:15 Q2:16
US ROW
$155
$215
$244 $249
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q2:16 net sales $249M; +2% Y/Y (+3% Y/Y excluding negative F/X); +11% Q/Q
• 2016 Growth Drivers ABRAXANE® is a standard of care in the U.S. for
pancreatic cancer Increasing market share in Europe Demand in breast and lung cancer stabilizing
• Future Growth Drivers Ph II data from tnAcity® trial expected by year-end Ph III data with I/O combinations expected in 2017 and
2018 Ph III adjuvant pancreatic trial (apact®) data expected in
2017
Net Sales ($M)
Advancing Hematology & Oncology Pipeline
23
Selected Key Hematology & Oncology Pipeline Assets
24
• AG-221 (Agios) RRAML De novo AML
• Luspatercept (Acceleron) Lower-risk RS+ MDS Beta-thalassemia
• CC-486 AML MDS
Late Stage
• Durvalumab (AstraZeneca) RRMM MDS, AML Lymphoma, CLL
• CD19 CAR-T (Juno) RRALL, RRNHL and
RRCLL• BCMA (bluebird bio) RRMM
I/O Collaborations
• CC-122 RRNHL RRCLL RRMM
• CC-220 RRMM
• CC-90009 AML
Next Generation CELMoD®s
Significant progress with AG-221 and luspatercept programs in myeloid diseases Durvalumab FUSIONTM program continues to expand CAR-T programs with Juno and bluebird making progress Next generation CELMoD®s moving forward in the clinic
2016 Continues to be Strong for Hematology & Oncology
25
Highly successful REVLIMID® NDMM launch; combinations with novel therapies support role as a backbone of therapy
REVLIMID® net product sales guidance for 2016 now ~$6.8B POMALYST®/IMNOVID® sales strong; ABRAXANE® stable
REVLIMID® maintenance after SCT submitted in EU; U.S. submission expected in H2:16 POMALYST®/IMNOVID® label updated with renal impairment data in U.S.; EU update expected
in H2:16
Early- and Mid-Stage Programs AdvanceEarly- and Mid-Stage Programs Advance
Robust Results from Key Products
On-Track with Key Regulatory Activities
Scott Smith
Q2 2016 I&I Franchise Results
27
– Revenue continued to accelerate through Q2:16 in both U.S. and ROW– Strong TRx trajectory relative to competitor products– Exceptional foundation for product performance: share gains of growing market, increasing prescriber adoption
and treatment duration
Accelerating Sales Performance and Momentum for OTEZLA®Accelerating Sales Performance and Momentum for OTEZLA®
– Development underway in ulcerative colitis and Behçet's disease, and developing next steps for AS– Preparing for launch in four major European markets and Japan– Advancing regulatory submissions in Eastern Europe, Asia and Latin America– Ph II POC trial in atopic dermatitis completed; Evaluating next steps
Maximizing OTEZLA®’s Potential ValueMaximizing OTEZLA®’s Potential Value
– GED-0301 endoscopy trial completed enrollment– Executing pivotal program for GED-0301 in Crohn’s disease– Ozanimod Ph II UC study results published in the New England Journal of Medicine, and presented at DDW
May 2016 congress
Advancing Development of I&I PipelineAdvancing Development of I&I Pipeline
Advancing Revenue Growth Drivers for OTEZLA®
28
$129$167 $175
$217
$10
$16 $21
$25
Q3:15 Q4:15 Q1:16 Q2:16US ROW
$139
$183$196
$242Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q2:16 net sales $242M; +170% Y/Y, +24% Q/Q growth– U.S. sales increased +24% Q/Q; ROW +21% Q/Q
• Increasing OTEZLA® adoption in the U.S. on top of market TRx expansion (+23% in Q2:16 vs. Q2:15)
• Performance indicators predictive of continued strong growth
• Geographic expansion advancing– Achieved reimbursement in 14 EU countries– Approval in Japan expected by year-end
• New long-term data enhancing clinical profile– 3-year data from PALACE and ESTEEM programs
Net Sales ($M)
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
Apr
-14
May
-14
Jun-
14
Jul-1
4
Aug
-14
Sep
-14
Oct
-14
Nov
-14
Dec
-14
Jan-
15
Feb-
15M
ar-1
5
Apr
-15
May
-15
Jun-
15
Jul-1
5
Aug
-15
Sep
-15
Oct
-15
Nov
-15
Dec
-15
Jan-
16
Feb-
16M
ar-1
6
Apr
-16
May
-16
Jun-
16
OTEZLA
STELARA
COSENTYX
TALTZ
Notes: STELARA launched Oct 2009; approved for psoriasis, PsA and AS. OTEZLA® launched Apr 2014; approved for psoriasis and PsA. COSENTYX launched Feb 2015; approved for psoriasis, PsA and AS. TALTZ approved Apr 2016; approved for psoriasis. TRx reflects total number of new and refill prescriptions, per week, to-dateSource: IMS SMART data; through week ending 8 July 2016
US Weekly TRx
OTEZLA® Demonstrating Strong TRx Progression Relative to Recent Market Entrants
29
Ozanimod Clinical Development Continues to Progress on or Ahead of Schedule
Program Updates• Ph III MS trials completed enrollment; data expected in H1:17
• MS NDA filing expected in 2017
• UC Ph III (TRUE NORTH) study enrollment ongoing; data expected in 2018
• Crohn’s disease Ph II (STEPSTONE) study enrolling patients
Strategic Data Dissemination• UC Ph II (TOUCHSTONE) trial results published in
The New England Journal of Medicine May 2016
• TOUCHSTONE histologic data released as oral presentation at the DDW (Digestive Disease Week) May 2016 Congress
30
GED-0301 Registration Program Advancing; Endoscopy Trial (CD-001) Completed Enrollment
• Objective to explore endoscopic improvement and durability following initial treatment with GED-0301
• Induction phase (weeks 0 - 12): three treatment arms
• Observation phase (weeks 12 - up to 52): no treatment
• Patient population with advanced disease -active, moderate to severe Crohn’s confirmed by CDAI and SES-CD criteria
• Multicenter study with over 80% of patients enrolled from North America
• Completed enrollment; 12-week data expected in H2:16
CD-001 Trial Design
Week 12
No Treatment
Week 4 Week 8Week 0
Induction Phase Observation Phase
PlaceboArm B: GED-0301 160 mg/day
Arm A: GED-0301 160 mg/day
Arm C: GED-0301 160 mg/day Placebo
Up to Week 52
• Randomization 1:1:1• Primary Endpoint: Change in Simplified Endoscopic Activity Score
for Crohn's disease (SES-CD) from baseline at week 12• Key secondary endpoint: Crohn's Disease Activity Index (CDAI)
Study Overview
31
Maximizing I&I Portfolio Value
Continue strong operating momentum for OTEZLA® in the US Expand utilization across geographies and indications Advance launch preparations for multiple major European markets and Japan
Maximizing the OTEZLA® Opportunity
Advance ozanimod Ph III trial in ulcerative colitis Complete enrollment of ozanimod Ph II trial in Crohn’s disease Progress enrollment of GED-0301 registration trials in Crohn’s disease Completed enrollment of GED-0301 Ph II trial in UC
Moving Ozanimod and GED-0301 Forward
Complete CC-220 Ph II SLE trial Complete sotatercept Ph IIb trial
Advancing Development of the I&I Pipeline
32
Jackie Fouse
2016 Anticipated Milestones
Regulatory Submissions/Decisions Submit REVLIMID® in U.S. and EU ✓ for maintenance post-ASCT Submit POMALYST® renal impairment data in US and EUX Submit ABRAXANE® for early-stage breast cancer in EU Submit OTEZLA® for PSOR in Japan CHMP opinion on REVLIMID® for MCL
Trial Enrollment Complete enrollment in AUGMENT® – REVLIMID® in RR FL Complete enrollment in apact® – ABRAXANE® in adjuvant PanC Complete enrollment in RELIEF® – OTEZLA® in Behçet’s disease Complete enrollment in Ph II trial of CC-486 + pembrolizumab in NSCLC Initiate enrollment in Ph I trial of BCMA CART in RRMM Initiate enrollment in FUSION™ program with durvalumab in NDMM,
RRMM, NHL, MDS/AML
Trial Initiations Initiate pivotal trial with CC-122 in NHL Initiate Ph III trial with OTEZLA® in AD Initiate second Ph III trial with GED-0301 Initiate Ph III trial with RPC4046 in EoE
Financial Performance Total Net Product Sales $10.5-11B1 Total Net Product Sales ~$11B2
Net REVLIMID® sales $6.6-6.7B1 Net REVLIMID® sales $6.8B2
Adj. operating margin ~53.5%1 Adj operating margin ~54.0%2
Adj. EPS $5.50-$5.701 Adj EPS $5.70 to $5.752
34
Clinical DataX Ph III REMARC – REVLIMID® in DLCBL maintenance Ph III CONTINUUM® – REVLIMID® in CLL maintenanceX Ph III ETNA – ABRAXANE® in neoadjuvant BC Ph III POSTURE® – long-term radiographic data of OTEZLA® in AS Ph III PSA-006 – OTEZLA® in biologic-naïve PsA Ph II CC-122 in NHL Ph II motolimod (VTX-2337) in SCCHN and ovarian cancer Ph II portion of tnAcity® – ABRAXANE® in TNBC Ph II OTEZLA® in AD ✓ and UC Ph II CC-220 in SLE Ph II RPC4046 in EoE Pharmacokinetic comparability study – OTEZLA® once-daily formulation
R&ED File at least 8 IND’s Advance at least 2 compounds to mid-to-late stage development
1. Original January 2016 2. Updated July 2016
Data from at Least 18 Phase III Trials Expected by 2018
35
2016 2017 2018
PSA-006Biologic-naïve PsA
ETNANeoadjuvant BC
CONTINUUM®
CLL maintenance
REMARCDLBCL maintenance
apact®Adjuvant PanC
AUGMENT®
RR fNHL
IMpower 130*I/O non-squamous NSCLC
SUNBEAMMS
IMpower 131*I/O squamous NSCLC
RADIANCEMS
RELEVANCE®
1st Line fNHL
OPTIMISMM®
2nd Line+ RRMM
IMpassion 130*I/O TNBC
abound®.sqmSquamous maintenance
RELIEFTM
Behçet’s
ozanimod
ozanimod TRUE NORTHUC
ozanimod
CD-003Crohn’s
GED-0301
CD-002Crohn’s
GED-0301
*Roche Ph III trial in combination with atezolizumab
Data from at Least 18 Phase III Trials Expected by 2018
36
2016 2017 2018
PSA-006Biologic-naïve PsA
ETNANeoadjuvant BC
CONTINUUM®
CLL maintenance
REMARCDLBCL maintenance
apact®Adjuvant PanC
AUGMENT®
RR fNHL
IMpower 130*I/O non-squamous NSCLC
SUNBEAMMS
IMpower 131*I/O squamous NSCLC
RADIANCEMS
RELEVANCE®
1st Line fNHL
OPTIMISMM®
2nd Line+ RRMM
IMpassion 130*I/O TNBC
abound®.sqmSquamous maintenance
RELIEFTM
Behçet’s
ozanimod
ozanimod TRUE NORTHUC
ozanimod
CD-003Crohn’s
GED-0301
CD-002Crohn’s
GED-0301
*Roche Ph III trial in combination with atezolizumab
Additional Catalysts in H2:16
• GED-0301 endoscopy 12-week data• Phase II data from:
• CC-122 in NHL• Motolimod in SCCHN and ovarian cancer• tnAcity® - ABRAXANE® in TNBC• OTEZLA® in UC• CC-220 in SLE
• Medical Congresses – UEGW, ASH and SABCS• R&D Deep Dive Series – Sept 2016
Q2 2016 Conference CallJuly 28, 2016
Appendix
Celgene Pipeline
39
Celgene Pipeline
40
Celgene Pipeline
41
Celgene Pipeline
42
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance Post-VMP induction
Trial NameMM-026ARUMM
Phase III
Target Enrollment 350
Design
2:1 randomizationInduction with Melphalan/prednisone/bortezomib (VMP)
for 6-9 cyclesArm A: REVLIMID® (10mg) d 1-21
for 28-day cycleArm B: Placebo d 1-21 for 28-day cycle
Primary Endpoint Progression Free Survival
Status Trial enrolling
43
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance in ASCT EligibleTrial Name MYELOMA XI
Phase III
Target Enrollment 3,970
Design
Arm A: Cyclophosphamide (500mg) d1,8,15; THALOMID® (100mg d1-21 then 200mg daily), Dexamethasone (40mg) d1-4, 12-15 for minimum of 4 21-day cycle
Arm B: REVLIMID® (25mg) d 1-21, Cyclophosphamde (500mg) d1,8, dexamethasone (40mg) d1-4,12-15 for minimum of 4 28-day cycles
Arm C: Cyclophosphamde (500mg) d1,8, Carfilzomib (20 mg/m2) d 1,2 cycle 1 then (36 mg/m2) d 1,2,8,9,15,16, REVLIMID® (25mg) d1-21, Dexamethasone (40mg) d 1-4,8,9,15,16 for 4 21-day cycles
Patients with no change, progressive disease, PR or MR randomized toArm A: Bortezomib (1.3mg/m2) d 1,4,8,11, Cyclophosphamide (500mg) d 1,8,15, Dexamethasone (20mg) d 1,2,4,5,8,9,11,12 for
max of 8 21-day cyclesArm B: No treatmentAll patients go to SCT
After SCT randomization to:Arm A: REVLIMID® (10mg) d 1-21 for 28-day cycle to disease progression
Arm B: No maintenance
Primary Endpoint Overall Survival and Progression Free Survival
Status Trial enrolling
44
POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs
Patient Population RRMM
Trial NameMM-007
OPTIMISMM®
Phase III
Target Enrollment 782
Design
Arm A: POMALYST®/IMNOVID® (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 Survival
Status Trial enrolling; Data in 2018E
45
MDS/AML/MF Late Stage Programs
Patient Population Low risk/INT-1 transfusion-dependent MDS Post induction AML Maintenance
MoleculeCC-486
(Oral Azacitidine)CC-486
(oral azacitidine)
Trial Name AZA-MDS-003 CC-486-AML-001
Phase III III
Target Enrollment 386 460
DesignArm A: CC-486 (150mg or 200mg)
Arm B: PlaceboArm A: CC-486 (150mg or 200mg)
Arm B: Best Supportive Care
Primary Endpoint RBC-transfusion independence for more than 12 weeks Overall Survival
Status Trial enrolling Trial enrolling
46
MDS/AML/MF Late Stage Programs
Patient Population Anemia in to Very Low-, Low-, or Intermediate-Risk MDS
Red Blood Cell Transfusion Dependent Beta-Thalassemia
Molecule Luspatercept Luspatercept
Trial Name MEDALISTTM BELIEVETM
Phase III III
Target Enrollment 210 300
DesignArm A: Luspatercept (Starting dose of 1.0 mg/kg
subcutaneous injection every 3 weeksArm B: Placebo (Subcutaneous injection every 3 weeks)
Arm A: Luspatercept (1mg/kg plus Best Supportive CareArm B: Placebo plus Best Supportive Care
Primary Endpoint Red Blood Cell Transfusion Independence (RBC-TI) ≥ 8 weeks
Proportion of subjects with hematological improvement from Week 13 to Week 24 compared to 12-week prior to
randomizationHematological improvement from Week 13 to Week 24
compared to the 12-week.
Status Trial enrolling Trial enrolling
47
MDS/AML/MF Late Stage Programs
Patient Population IDH2 Mutant AML
Molecule AG-221 (CC-90007)
Trial Name IDHENTIFYTM
Phase III
Target Enrollment 280
Design Arm A: AG 221 (100 mg daily , 28-day cycle) + Best supportive care
Arm B: Best supportive care
Primary Endpoint Overall survival
Status Trial enrolling
48
REVLIMID® Chronic Lymphocytic Leukemia Late Stage Program
Patient Population Maintenance in 2nd Line CLL
Trial NameCLL-002
CONTINUUM®
Phase III
Target Enrollment 400
DesignArm A: REVLIMID® (starting dosage 2.5mg/day escalated to
10mg/day) until disease progression - 28-day cycleArm B: Placebo
Primary Endpoint Overall Survival and ProgressionFree Survival
StatusEnrollment complete
Data in 2016E
49
REVLIMID® Lymphoma Late Stage Programs
Patient Population Maintenance 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
DesignArm A: REVLIMID® D1-21 of 28-day
cycle for 24 monthsArm B: Placebo D1-21 of 28-day
cycle for 24 months
Arm A: REVLIMID® (starting dose 20mg) D2-22 for up to 18 28-day cycles and Rituximab (starting
dose 375 mg/m2) weekly for up to 12 28-day cyclesArm B: Physician’s choice of rituximab-CHOP, rituximab-CVP
or rituximab-bendamustine
Primary Endpoint Progression Free Survival Complete Response Rate and Progression Free Survival
StatusPrimary endpoint met
Data in 2016EEnrollment complete
Data in 2017E
50
REVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Follicular Lymphoma Untreated Activated B-Cell DLBCL
Trial NameAUGMENTTM
NHL-007ROBUST®
DLC-002
Phase III III
Target Enrollment 500 560
Design
Arm A: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 2-5 for 5
28-day cyclesArm B: Placebo D1-21, / Rituximab 375 mg/m2 weeklyfor cycle 1 then D 1 of cycles 2-5 for 5 28-day cycles
Arm a: REVLIMID® (15mg) D1-14/+ R-CHOP21 for 6 21-day cycles
Arm B: Placebo + R-CHOP21 for 6 cycles
Primary Endpoint Progression Free Survival Progression Free Survival
StatusTrial enrollingData in 2017E
Trial enrollingData in 2019E
51
REVLIMID® Lymphoma Late Stage Programs
Patient Population Relapsed or Refractory Indolent Lymphoma
Trial NameMAGNIFYTM
NHL-008
Phase III
Target Enrollment 500
Design
Arm A: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 3, 5, 7,9 and 11 for 12 28-day cycles followed by REVLIMID® (10mg) D1-21 / Rituximab 375 mg/m2 D 1 of cycles 13, 15,
17,19, 21, 23, 25, 27 and 29 for 18 28-day cycles followed by REVLIMID® (10mg) D 1-21 until disease progression – 28 day cycle
Arm B: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 3, 5, 7,9 and 11 for 12 28-day cycles followed by REVLIMID® (10mg) D1-21 / Rituximab 375 mg/m2 D 1 of cycles 13, 15,
17,19, 21, 23, 25, 27 and 29 for 18 28-day cycles
Primary Endpoint Progression Free Survival
StatusTrial enrollingData in 2020E
52
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population Maintenance After Induction in Squamous Non-Small Cell Lung Cancer
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
Trial Name NSCL-003PANC-003
apact®
Phase III III
Target Enrollment 540 800
Design
Induction: ABRAXANE® (100 mg/m2) D 1, 8,and 15 / Carboplatin (6 mg min/mL) D 1 for
4 21-day cyclesMaintenance:
Arm A: ABRAXANE® (100 mg/m2) D 1 and 8 plus BSC until disease progression –
21-day cycleArm B: BSC until disease progression
Arm A: ABRAXANE® (125 mg/m2) / Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28-day cycles
Arm B: Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28-day cycles.
Primary Endpoint Progression Free Survival Disease Free Survival
Status Trial enrollingEnrollment complete
Data in 2017E
53
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population First-Line Triple Negative Metastatic Breast Cancer First Line Stage IIIB / IV Squamous NSCLC
Trial NametnAcity®
ABI-007-MBC-001NSCL-003
Abound.sqm®
Phase II/III III
Target Enrollment 240/550 260
Design
Phase IIArm A: ABRAXANE® 1(25mg/m2) / Gemcitabine (1000 mg/m2) D 1
and 8 – 21-day cycleArm 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 cyclePhase III
Arm 1: Selected phase II ABRAXANE® armArm 2: Gemcitabine (1000 mg/m2) / Carboplatin AUC 2 IV, D 1
and 8 – 21-day cycle
Arm A: Induction – ABRAXANE® (100 mg/m2) D 1, 8 and 15 / Carboplatin (6 mg/min/ml) D 1 of a 21-day cycle;
Maintenance – ABRAXANE® (100 mg/m) D 1 and 8 of a 21-day cycle or Best supportive care
Arm B: Induction – ABRAXANE® (100 mg/m2) D 1, 8 and 15 / Carboplatin (6 mg/min/ml) D 1 of a 21-day cycle;
Maintenance – Best supportive care
Primary Endpoint Progression Free Survival Progression Free Survival
StatusTrial enrolling;
Phase II data in 2016ETrial enrollingData in 2017E
54
I&I Late Stage Programs
Patient Population Untreated Moderate-to-SevereLate Stage Psoriatic Arthritis Active Behçet’s Disease
Molecule OTEZLA® OTEZLA®
Trial Name PSA-006BCT-002RELIEFTM
Phase III III
Target Enrollment 214 204
DesignArm A: OTEZLA® single agent (30mg)
twice dailyArm B: Placebo
Arm A; Placebo for 12 weeks followed by 30mg OTEZLA® twice daily for 52-weeksArm B: 30mg OTEZLA® twice daily for 64
weeks
Primary Endpoint ACR 20 at Week 16Area under the curve (AUC) for the number of oral ulcers from baseline through week
12
StatusPrimary endpoint met
Data at an major medical congress expected
Trial enrollingData in 2017E
55
I&I Late Stage Programs
Patient Population Active Crohn’s Disease Moderate to Severe Ulcerative Colitis
Molecule GED-0301 Ozanimod
Trial Name CD-002 TRUE NORTH
Phase III III
Target Enrollment 1,064 900
Design
Arm A: GED-301 160mg daily 12 weeks/GED-301 40mg daily 40 weeks
Arm B: GED-301 160mg daily 12 weeks/GED-301 40mg daily 4 weeks on/4 weeks off 40 weeks
Arm C: GED-301 160mg daily 12 weeks/GED-301 160mg daily 4 weeks on/4 weeks off 40 weeks
Arm A: Ozanimod 1mg (daily for induction and maintenance)
Arm B: Placebo (induction and maintenance)
Primary Endpoint Clinical remission defined by Crohn's Disease Activity Index (CDAI)
Clinical remission assessed by Mayo component sub-scores at week 10
Clinical remission assessed by Mayo component sub-scores at week 52
StatusEnrolling
Data in 2018EEnrolling
Data in 2018E
56
I&I Late Stage Programs
Patient Population Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis
Molecule Ozanimod Ozanimod
Trial Name SUNBEAM RADIANCE
Phase III II/III
Target Enrollment 1200 1200
DesignArm A: Ozanimod (0.5mg) daily/placebo IM weeklyArm B: Ozanimod (1mg) daily/placebo IM weekly
Arm C: Oral placebo daily/Beta-interferon IM weekly
Phase IIArm A: Ozanimod (0.5mg) dailyArm B: Ozanimod (1mg) daily
Arm C: Placebo dailyPhase III
Arm A: Ozanimod (0.5mg) daily/placebo IM weeklyArm B: Ozanimod (1mg) daily/placebo IM weekly
Arm C: Oral placebo daily/Beta-interferon IM weekly
Primary Endpoint Annualized relapse rate at month 12 Annualized relapse rate at month 24
StatusEnrollment complete
Data expected in H1:17EEnrollment complete
Data expected in H1:17E
57
Reconciliation Tables
Reconciliation Tables
59
2016
2015
2016
2015
Net pr
oduct s
ales
2,744.
5$
2,254.
1$
5,239.
2$
4,309.
3$
Other r
evenue
9.8
23.
7
26.7
49.
3
Total r
evenue
2,754.
3
2,277.
8
5,2
65.9
4,358.
6
Cost o
f goods
sold (
exclud
ing am
ortizat
ion of
acquire
d intan
gible a
ssets)
110.9
100
.8
216.8
204
.8
Resea
rch an
d deve
lopme
nt948
.7
1,110.
0
1,6
81.9
1,616.
0
Sel
ling, ge
neral a
nd adm
inistrat
ive732
.1
616.8
1,2
75.1
1,146.
0
Am
ortizat
ion of
acquire
d intan
gible a
ssets
174.8
63.
7
266.6
127
.3
Acqui
sition re
lated c
harges
and re
structu
ring, ne
t(35
.9)
(29.3)
0.3
(10.3)
Tot
al cost
s and
expens
es1,9
30.6
1,8
62.0
3,440.
7
3,0
83.8
Opera
ting inc
ome
823.7
415
.8
1,825.
2
1,2
74.8
Interes
t and in
vestme
nt inco
me, ne
t7.2
8.8
14.
0
17.8
Inte
rest (e
xpense
)(12
3.3)
(48
.3)
(245.2
)
(97.5)
Oth
er inco
me (ex
pense)
, net
(12.5)
94.
5
22.7
102
.8
Incom
e befo
re inco
me tax
es695
.1
470.8
1,6
16.7
1,297.
9
Incom
e tax p
rovisio
n 96.
9
114.6
217
.8
222.8
Net in
come
598.2
$
356
.2$
1,398.
9$
1,075.
1$
Net in
come p
er com
mon s
hare:
Basic
0.77
$
0.45
$
1.8
0$
1.35
$
Dil
uted
0.75
$
0.43
$
1.7
4$
1.30
$
Weigh
ted av
erage
shares
:Ba
sic775
.6
793.0
778
.1
796.0
Dil
uted
801.5
825
.3
804.7
829
.7
June 3
0,De
cember
31,
2016
2015
Balan
ce she
et ite
ms:
Cash,
cash e
quival
ents &
marke
table s
ecuritie
s6,4
03.7
$
6,5
51.9
$
Tot
al asse
ts*26,
562.0
26,964
.4
Lon
g-term
debt*
14,312
.1
14,
161.4
Total s
tockho
lders'
equity
5,548.
8
5,919.
0
Celge
ne Co
rporat
ion an
d Subs
idiarie
sCo
ndense
d Cons
olidate
d Stat
ement
s of In
come
(Unaud
ited)
(In mi
llions,
excep
t per s
hare d
ata) Jun
e 30,
Three-
Month
Period
s Ende
dSix
-Mont
h Perio
ds End
edJun
e 30,
* Tota
l asset
s and
long-te
rm deb
t as of
Decem
ber 31
, 2015
have b
een ad
justed
to refle
ct the
retroac
tive ad
option
of AS
U 2015
-03 in
the fir
st qua
rter of
2016.
ASU 2
015-03
require
s the p
resent
ation o
f debt i
ssuanc
e cost
s as a
reduct
ion of
long-te
rm deb
t.
Reconciliation Tables
60
20162015
20162015
Net inco
me - GA
AP598.
2$
356.2
$
1,39
8.9$
1,07
5.1$
Before
tax adju
stments:
Cost of
goods s
old (excl
uding am
ortization
of ac
quired in
tangible
assets):
Sha
re-based
compens
ation exp
ense
(1)8.6
8.1
17.6
14.8
Resear
ch and d
evelopm
ent:
Share-b
ased com
pensation
expense
(1)63.9
63.6
126.
1
119.8
Upfront
collabor
ation exp
ense(2)
284.0
569.
5
364.0
588.
5
Selling
, general
and adm
inistrativ
e:
Share-b
ased com
pensation
expense
(1)85.0
76.0
160.
3
141.9
Litigation
-related
loss con
tingency
accrual e
xpense
(3)100.
0
-
100.0
-
Amortiz
ation of a
cquired
intangible
assets
(4)174.
8
63.7
266.6
127.
3
Acquis
ition rela
ted (gai
ns) char
ges and
restruct
uring, ne
t:
Change
in fair va
lue of co
ntingent
consider
ation(5)
(43.7)
(29.
3)
(10.7)
(10.
3)
Res
tructurin
g charge
s(6)
7.8
-
11.0
-
Net inco
me tax
adjustme
nts(7)
(126.7)
(89.0)
(217
.6)
(147
.3)
Net
income
- Adjus
ted1,15
1.9$
1,01
8.8$
2,21
6.2$
1,90
9.8$
Net inco
me per
common
share -
Adjuste
dBas
ic1.49
$
1.28
$
2.85
$
2.40
$
Dilu
ted1.44
$
1.23
$
2.75
$
2.30
$
Six-Mon
th Perio
ds Ended
Celgen
e Corp
oration
and Sub
sidiarie
sRec
onciliat
ion of G
AAP to A
djusted
Net Inc
ome(In m
illions,
except p
er shar
e data)
Three-M
onth Per
iods End
ed
In addit
ion to fi
nancial
informa
tion pre
pared i
n accord
ance wi
th U.S. G
AAP, thi
s press
release
also con
tains ad
justed f
inancial
measure
s that
we belie
ve provi
de inve
stors an
d mana
gement
with sup
plementa
l inform
ation re
lating to
operati
ng perfo
rmance
and tren
ds that
facilitat
e com
parison
s betwee
n period
s and w
ith respe
ct to pro
jected i
nformat
ion. The
se adjus
ted fina
ncial me
asures
are non
-GAAP
and sho
uld be
conside
red in a
ddition
to, but n
ot as a
substitu
te for, th
e inform
ation pr
epared
in acco
rdance
with U
.S. GAAP
. We typ
ically e
xclude c
ertain
GAAP ite
ms that
manage
ment do
es not b
elieve a
ffect ou
r basic o
peration
s and th
at do no
t meet th
e GAAP
definiti
on of un
usual o
r non-
recurrin
g items.
Other c
ompanie
s may de
fine the
se measu
res in d
ifferent
ways.
June 30,
June 30,
Reconciliation Tables
61
Explanation of adjustments:(1) Exclude share-based compensation expense totaling $157.5 for the three-month period ended June 30, 2016 and $147.7 for the three-month period
ended June 30, 2015. Exclude share-based compensation expense totaling $304.0 for the six-month period ended June 30, 2016 and $276.5 for the six-month period ended June 30, 2015.
(2) Exclude upfront payment expense for research and development collaboration arrangements.(3) Exclude loss contingency accrual expense related to a contractual dispute.(4) Exclude amortization of intangible assets acquired in the acquisitions of Pharmion Corp., Gloucester Pharmaceuticals, Inc. (Gloucester), Abraxis
BioScience Inc. (Abraxis), Celgene Avilomics Research, Inc. (Avila), and Quanticel Pharmaceuticals, Inc. (Quanticel). The excluded amortization expense for the three- and six-month periods ended June 30, 2016 includes $83.1 million related to the impairment of an intangible asset acquired in the Avila acquisition.
(5) Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila, Nogra Pharma Limited and Quanticel.
(6) Exclude restructuring charges related to our relocation of certain operations into our two Summit, NJ locations as well as costs associated with certain headcount reductions.
(7) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments, including the effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits, and adjustments related to the gain on the sale of certain assets.
Reconciliation Tables
62
LowHig
h
Project
ed net in
come - G
AAP
(1)3,07
4.9$
3,26
6.5$
Before
tax adju
stments
:Cos
t of goo
ds sold
(excludin
g amortiz
ation of
acquire
d intang
ible asse
ts): Sh
are-base
d compe
nsation
expense
37.0
35.2
Researc
h and de
velopme
nt: Sh
are-base
d compe
nsation
expense
263
.4
250.9
Up
front co
llaboratio
n expen
se 601
.0
601.0
Selling,
general
and adm
inistrativ
e: Sh
are-base
d compe
nsation
expense
334
.8
318.9
Lit
igation-
related
loss con
tingenc
y accrua
l expen
se100
.0
100.0
Amortiz
ation of
acquire
d intang
ible asse
ts458
.2
418.6
Acquis
ition rela
ted (gai
ns) cha
rges and
restruc
turing, n
et: Ch
ange in
fair val
ue of co
ntingen
t consid
eration
43.7
39.5
Restru
cturing
charges
30.0
15.0
Net inc
ome tax
adjustm
ents(348
.8)
(411
.1)
Project
ed net in
come - A
djusted
4,594.2
$
4,634.5
$
Project
ed net in
come pe
r diluted
common
share -
GAAP
3.82$
4.05$
Project
ed net in
come pe
r diluted
common
share -
Adjuste
d5.70
$
5.75
$
Project
ed weigh
ted ave
rage dilu
ted shar
es806
.0
806.0
(1)Our
project
ed 2016
earning
s do not
include
the eff
ect of a
ny busin
ess com
bination
s, collabo
ration ag
reements
, asse
t acquis
itions, in
tangible
asset im
pairmen
ts, addit
ional litig
ation-re
lated lo
ss conti
ngency
accrual
s or
change
s in the
fair valu
e of our
CVRs i
ssued as
part of
the acq
uisition
of Abrax
is that m
ay occu
r after t
he day
prior to
the date
of this p
ress rele
ase.
Celgen
e Corp
oration
and Sub
sidiarie
sRec
onciliat
ion of F
ull-Year
2016 P
rojected
GAAP
to Adjus
ted Net
Income
(In millio
ns, exce
pt per s
hare da
ta)
Range