q2 2016 eps deck - final - 7 27 16 - for distribution.pptx ... · adjusted diluted earnings per...

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


ASH 2015 and SWOG data release


Updated mSMART & NCCN Guidelines


Rd approval in ndMM

Rd approval in ndMM

Ph III Rd+X readouts and FDA approvals


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







Rd approval in ndMM

Rd approval in ndMM







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


44

POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs

Patient Population RRMM

Trial NameMM-007

OPTIMISMM®

Phase III


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


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


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


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


Patient Population IDH2 Mutant AML

Molecule AG-221 (CC-90007)

Trial Name IDHENTIFYTM

Phase III


Design Arm A: AG 221 (100 mg daily , 28-day cycle) + Best supportive care

Arm B: Best supportive care

Primary Endpoint Overall survival


48

REVLIMID® Chronic Lymphocytic Leukemia Late Stage Program

Patient Population Maintenance in 2nd Line CLL

Trial NameCLL-002

CONTINUUM®

Phase III


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


Patient Population Relapsed or Refractory Follicular Lymphoma Untreated Activated B-Cell DLBCL

Trial NameAUGMENTTM

NHL-007ROBUST®

DLC-002

Phase III III


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


Patient Population Relapsed or Refractory Indolent Lymphoma

Trial NameMAGNIFYTM

NHL-008

Phase III


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


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


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


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


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


Patient Population Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis

Molecule Ozanimod Ozanimod

Trial Name SUNBEAM RADIANCE

Phase III II/III


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


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.


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,


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.


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

q2 2016 eps deck - final - 7 27 16 - for distribution.pptx ... · adjusted diluted earnings per...

Documents