Q4 2015 EPS Deck - FINAL - 1.28.16...2016/01/28 · Q4:15 and FY2015 Hematology & Oncology...

1/28/2016

1

Q4 and Full-Year 2015 Conference Call

January 28, 2016

Forward Looking Statements and Adjusted Financial Information

This presentation contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking

statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar

expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak

only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or

future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are

difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-

looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on

Form 10-K and our other reports filed with the Securities and Exchange Commission.

In addition to unaudited financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted financial

measures that we believe provide investors and management with supplemental information relating to operating performance and trends

that facilitate comparisons between periods and with respect to projected information. These adjusted measures are non-GAAP and

should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically

exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of

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 of these adjusted financial measures to the most comparable GAAP

measures, may be found on our website at www.Celgene.com in the “Investor Relations” section.

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Attendees

3

Bob Hugin, Chairman & Chief Executive Officer

Peter Kellogg, Chief Financial Officer

Jackie Fouse, President, Global Hematology & Oncology

Scott Smith, President, Global I&I

Q&A

Mark Alles, President & Chief Operating Officer

Bob Hugin

1/28/2016

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2015: A Year Of Significant Achievement

5

– Net product sales 21% Y/Y growth

– Growth across product lines driven by increased market share and duration

Delivering on the Potential of Our Key ProductsDelivering on the Potential of Our Key Products

– Key regulatory approvals across entire portfolio of products

– Advancing over 100 clinical trials with approximately 18,000 patients

Broadening Our Franchise FootprintBroadening Our Franchise Footprint

– Advanced early pipeline and existing collaborations; Entered new collaborations

– Organizational changes provide continuity and strengthen leadership structure

Continuing to Maximize Our Future Potential Continuing to Maximize Our Future Potential

Peter Kellogg

1/28/2016

4

Full-Year 2015 Financial Highlights

7

2015 year-over-year product sales grew 21% and adjusted diluted EPS grew 27%

Adjusted operating margins improved by 140 bps

Outstanding Operating ResultsOutstanding Operating Results

$3.3B in shares repurchased in FY2015

FY2015 adjusted effective tax rate improved by 80 bps due to favorable geographic mix

Adding Value with Financial DriversAdding Value with Financial Drivers

Strong product growth across all franchises

Investments in R&D while achieving meaningful SG&A leverage

Excellent Performance on Operating MetricsExcellent Performance on Operating Metrics

Advanced pivotal/phase III trials and accelerated early- to mid-stage pipeline

Accelerated critical investments to deliver sustainable, high-growth into the next decade

Investing for the FutureInvesting for the Future

Total Net Product Sales(Growth Rates = Growth vs. Prior Year Period)

$1,725

$2,055

$2,539

Q4:13 Q4:14 Q4:15

$6,362

$7,564

$9,161

2013 2014 2015

Mill

ion

s

↑22% ↑19% ↑18% ↑19%

Q4 Full Year

8

↑24% ↑21%

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5

Volume Drove Q4:15 and FY2015 Net Product Sales Growth

9

$0

$500

$1,000

$1,500

$2,000

$2,500

$3,000

Q4:14 Volume Price /Mix

Fx /Hedge

Q4:15

↑23.6%↓0.8%↑20.6% ↑3.8%

Contribution to Q4:15 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)

$0

$1,500

$3,000

$4,500

$6,000

$7,500

$9,000

2014 Volume Price /Mix

Fx /Hedge

2015

↑21.1%↓1.4%↑19.4% ↑3.1%

Contribution to FY2015 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)

Adjusted Diluted Earnings Per Share(Growth Rate = Growth vs. Prior Year Period)

$0.76

$1.01

$1.18

Q4:13 Q4:14 Q4:15

$2.98

$3.71

2013 2014 2015

↑14% ↑33% ↑21% ↑24%

Do

llars

Per

Sh

are

$4.71

10

↑17% ↑27%

Footnote: Adjusted EPS is split-adjusted for all periods presented; Full-year 2015 includes $0.14 per share dilutive impact related to the Receptos Inc. acquisition

Q4 Full Year

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6

Key P&L Line Items (Adjusted)

Q4:15∆ vs.Q4:14

FY2015∆ vs.

FY2014

Product Gross Margin 96.2% ↑90 bps 95.8% ↑60 bps

R&D expenses% of revenue

$649M 25.3%

↑240 bps $2,044M22.1%

↑60 bps

SG&A expenses% of revenue

$533M 20.8%

↓220 bps $2,011M21.7%

↓150 bps

Operating Margin 50.1% ↑50 bps 52.0% ↑140 bps

Effective Tax Rate 14.9% ↓40 bps 15.2% ↓80 bps

11

Q4:15 and FY2015 Adjusted Diluted EPS Growth Driven by Increased Operating Income

12

Q4:14 Operating Income

Financial Income / Expense

Tax Rate Share Count

Q4:15

$1.18($0.12)$0.25$1.01 $0.01 $0.03

Contribution to Q4:15 Adjusted Diluted EPS

2014 Operating Income

Financial Income / Expense

Tax Rate Share Count 2015

$4.71($0.06)$0.93$3.71 $0.07 $0.06

Contribution to FY2015 Adjusted Diluted EPS

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Cash and Marketable Securities

• Cash flow from operations was $2.5B during FY2015

• In FY2015, purchased ~$3.3B of shares

• In Q4:15, purchased ~$0.4B of shares

• ~$3.9B remaining under existing stock repurchase program

• In FY2015, issued an aggregate of $8.0B in three-, five-, seven-, ten- and thirty-year bonds

13

(in Billions) 12/31/15 12/31/14

Cash and Marketable Securities $6.55 $7.55

FY2016 Guidance∆ vs.

FY2015

Total Net Product Sales $10.5B-$11.0B ↑ ~17%1

REVLIMID® Net Product Sales $6.6B-$6.7B ↑ ~15%1

Operating Margin2 ~53.5% ↑150 bps

Diluted EPS2 $5.50-$5.70 ↑ ~19%1

Weighted Average Diluted Shares 825M -

Full-Year 2016 Financial Outlook

Footnote: 1) Using midpoint of range; 2) Adjusted

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Jackie Fouse

Q4:15 and FY2015 Hematology & Oncology Franchise Results

16

– Q4:15 net sales growth of +17.5% Y/Y, +18.4% operational

– Strong momentum across myeloma portfolio

– Multiple product launches underway across a number of geographies

Strong Product Sales and Franchise Operating MomentumStrong Product Sales and Franchise Operating Momentum

– First full year of revenue for key products in several markets post-2015 launches

– Clinical data supports longer myeloma treatment durations and backbone role of IMiD®s

– ABRAXANE® ex-U.S. growth strong and I/O combination data emerging

2016 Product Growth Drivers2016 Product Growth Drivers

– REMARC data expected mid-2016; NHL phase III program progressing well

– Luspatercept and AG-221 pivotal trials enrolling; Advancing durvalumab and AG-120

– ABRAXANE® apact®, tnAcity®, ETNA trials and abound® program all ongoing

Investing in Next Generation Growth DriversInvesting in Next Generation Growth Drivers

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Q4:15 and FY2015 REVLIMID® Sales Summary

17

Current Results & Future Growth DriversCurrent Results & Future Growth Drivers

• Q4:15 sales $1,561M; +7% Q/Q, +18% Y/Y (+19% operational)

• FY2015 sales $5.8B; +16% Y/Y (+18% operational)

• Ongoing U.S. NDMM highly successful launch; EU uptake in early launch countries has been strong and is ongoing (Germany now 21% share in NSCT NDMM)

– Other EU G5 reimbursements on track to complete in H1:16

– Late 2015 approval in Japan for NDMM, launch coming in 2016

• 2016 growth drivers

First full year of revenue in several markets post-NDMM launch; launch in Japan

Strong momentum for increased duration of treatment and adoption of continuous treatment around the world

• Future growth drivers advancing

– Ph III NHL program accelerating with REMARC data expected in mid-2016 and AUGMENT® enrollment expected to complete by YE

– RVd added as category 1 preferred in NCCN guidelines for 1st line transplant and non-transplant candidates creating another opportunity for expanding the use of REVLIMID®-based triplets

$811 $873 $895 $956

$532 $571 $558

$605

Q1:15 Q2:15 Q3:15 Q4:15

US ROW

Sales ($M)

$1,343$1,444 $1,453

$1,561

2015 2016

Switzerland

France

Italy

Germany

Denmark

Sweden

Austria

Netherlands

Spain

Belgium

Reimbursement achieved

Global REVLIMID® NDMM Launch

Norway

Ireland

USA Japan

Wales

Portugal

Scotland

Finland

Preliminary Reimbursement

Greece

1/28/2016

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Q4:15 and FY2015 POMALYST®/IMNOVID® Sales Summary

19

$129 $144 $150$170

$70

$91 $107

$124

Q1:15 Q2:15 Q3:15 Q4:15

US ROW

$199

$235$257

$294


• Q4:15 sales $294M; +15% Q/Q, +45% Y/Y

• FY2015 sales $983M; +45% Y/Y, 95% from volume

• Successful global launch of POMALYST®/IMNOVID® continues

– Global demand continues to grow from market share and duration

– U.S. POMALYST® leading 3rd line+ share

– EU IMNOVID® achieving rapid penetration of 3rd line+ market and leads in 4th line

– Strong POMALYST® uptake in Japan following June launch

• 2016 growth drivers

First full year of launch in Japan

Duration trends increasing

Renal impairment data and label update

• Future growth drivers

POMALYST®/IMNOVID® combinations with other novel agents advancing

Sales ($M)

Q4:15 and FY2015 ABRAXANE® Sales Summary

20

$159 $170 $145

$180

$64 $74

$85

$90

Q1:15 Q2:15 Q3:15 Q4:15

US ROW

$223$244

$230

$270


• Q4:15 sales $270M; +17% Q/Q; +14% Y/Y, +18% volume

• FY2015 sales $967M; +14% Y/Y, +16% volume

• 2015 Growth Drivers

Maintaining leadership in pancreatic cancer in U.S.

Growth in U.S. market share in squamous NSCLC in H2:15

Strong uptake in pancreatic cancer in EU; metastatic breast cancer share shifting to 1st and 2nd line from 3rd line

• 2016 Growth Drivers

Continued uptake in PanC in EU; early days for NSCLC

Pancreatic cancer standard of care in U.S. and solid positions in lung and breast

• Future Growth Drivers

Advancing I/O strategy in NSCLC, TNBC; ongoing trials in support of label expansions in PanC, breast and lung

Significant Ph III data flow expected beginning in 2017 and continuing into 2018 and beyond

Sales ($M)

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11

REVLIMID® maintenance in DLBCL (REMARC Ph III)

REVLIMID® maintenance in RR CLL (CONTINUUM® Ph III)

ABRAXANE® in neoadjuvant therapy in HER2-negative high-risk BC and TNBC (ETNA Ph III and tnAcity® Ph II)

Proof-of-concept data for CC-122 in NHL and motolimod in ST

Full-Year 2016 Hematology & Oncology Franchise Outlook

21

REVLIMID® global net sales expected in range of $6.6B - $6.7B; +15% Y/Y*

ABRAXANE® and POMALYST®/IMNOVID® expected to exceed $1B

REVLIMID® maintenance after SCT in U.S. and EU

POMALYST®/IMNOVID® label update with renal impairment data in U.S. and EU

ABRAXANE® in early-stage breast cancer in EU

Clinical Data ExpectedClinical Data Expected

Advancing partnered programs luspatercept, AG-221, AG-120, durvalumab and BCMA Advancing partnered programs luspatercept, AG-221, AG-120, durvalumab and BCMA

Growth from Key Products

Expecting Key Regulatory Decisions

Footnote: * Growth calculated using the mid-point of the range

Scott Smith

1/28/2016

12

Q4:15 and FY2015 I&I Franchise Updates

23

– Revenue continued to accelerate throughout Q4

– Strong results across performance indicators (TRx, new-to-brand share, persistency)

– Data presented at major medical meetings and publications continue to enhance the profile

Accelerating U.S. Performance and Momentum for OTEZLA®Accelerating U.S. Performance and Momentum for OTEZLA®

– Uptake accelerating in early launch countries in Europe as well as Canada

– Multiple accelerated reimbursement approvals in EU; Japan filing planned in H1:16

Expanding OTEZLA®’s Global FootprintExpanding OTEZLA®’s Global Footprint

– Phase III trial for GED-0301 in CD; Phase III trial in CD and phase II trial in UC initiated

– Phase III trial for ozanimod in MS completed ahead of schedule

– Phase III trial for ozanimod in UC enrolling to plan; Phase II trial for ozanimod in CD initiated

Advancing Development of I&I PipelineAdvancing Development of I&I Pipeline

$60

$90

$139

$183

Q1:15 Q2:15 Q3:15 Q4:15

• Q4:15 net sales of $183M; FY2015 net sales of $472M

• Strong U.S. performance across all key metrics

• Geographic expansion advancing

• Launched in early reimbursement countries in the EU

• Launched in Canada

• Launch in rest of EU in 2016

• Filing in Japan in 2016 with launch in 2017

• New data enhances clinical profile

Strong Q4:15 OTEZLA® Revenue Performance

24

Global Sales ($M)Current Results & Future Growth Drivers

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13

Market Dynamics Supporting Positive U.S. Launch Performance

25

• Continued growth in TRx and new patient starts

• Consumer and physician campaigns continue to increase demand:

– Brand awareness

– Patient requests

– Number of trialists

• Market leader in new-to-brand share in PsA and PSOR

• Persistency to-date similar to that of biologics and ahead of oral DMARDs

U.S. Market Dynamics

Source: Symphony Health Solutions, 31 December 2015

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

COSENTYX ENBREL HUMIRA OTEZLA REMICADE STELARA

Enbrel 15.3%

Humira 34.4%

Stelara 25.9%

OTEZLA®

20.7%

OTEZLA® Derm Market Share Accelerating SurpassingEnbrel within First Year of PSOR Launch

Cosentyx3.6%

Remicade 0.1%

Geographic Expansion AdvancingOTEZLA® Launch Underway in Key Markets

2015 2016

Germany

Switzerland

Austria

France

Netherlands

Italy

Belgium

SpainScotland

Denmark

Sweden

Norway

Finland England & Wales

Reimbursement achieved

1/28/2016

14

• 2-Year radiographic data show delay in disease progression

• Presentation expected at a major medical meeting this year

• Evaluating next steps

Ankylosing Spondylitis Advancing a Robust Life Cycle Plan

OTEZLA®: An Emerging Blockbuster for Immune-Inflammatory Diseases

2016

2016

2016

Trial Expected Data

2016/17

Phase IIIBehçets Disease

Phase IIAtopic Dermatitis

Phase IIUlcerative Colitis

Bridging StudyOnce daily regimen

27

2017

Ankylosing SpondylitisLong-term follow-up

• First-in-class smad7 anti-sense treatment

• Phase III program in CD underway; endoscopic data expected in 2017

• Phase II trial in UC initiated

• Potential best-in-class next-generation S1P receptor modulator

• Phase III MS trials fully enrolled, filing expected in 2017

• Phase III trial in UC underway; data expected in 2018

• Phase II trial in CD initiated

Building a Leading Global Inflammation & Immunology Franchise

28

GED-0301

Ozanimod

Advancing Differentiated Oral Therapies Through Mid-to-Late Stage Trials

1/28/2016

15

Full-Year 2016 I&I Franchise Outlook

29

Continuing strong growth in U.S.

Accelerating ex-US market uptake in early launch countries; Preparing for the next wave of global launches

Expanding use and indications via robust life cycle plan

Maximizing the OTEZLA® Opportunity

Advancing ozanimod phase III trials in ulcerative colitis and multiple sclerosis

Completing enrollment in ozanimod phase II clinical program in Crohn’s disease

Progressing enrollment of GED-0301 registration trials in Crohn’s disease

Completing enrollment of GED-0301 phase II trial in UC

Moving Ozanimod and GED-0301 Forward

Complete CC-220 phase II SLE trial

Complete sotatercept phase IIb trial

Data from RPC-4046 phase II trial in eosinophilic esophagitis

Advancing the I&I Development Pipeline

Mark Alles

1/28/2016

16

We Are Well Positioned to Grow Through the Next Decade

31

Total Sales Potential

2015 2030

Commercial Productsand

Mid-to-Late Stage Pipeline

50 Potential New Products

>100 Indications

Data from at Least 18 Phase III Trials Expected by 2018

32

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

1/28/2016

17

Data from at Least 18 Phase III Trials Expected by 2018

33

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

Mid-Stage and Proof-of-Concept Data Expected by 2018

Hematology/Oncology • Ph II CC-122 in NHL

• Ph II ACY-1215 in RRMM

• Ph I/II durvalumab in hematological malignancies

• Ph Ib CC-220 and CC-122 in RRMM

• Ph I bb2121 (BCMA) in RRMM

• Ph II ABRAXANE® in TNBC (tnAcity®)

• Ph II motolimod (VTX-2337) in SCCHN and ovarian cancer

• Ph II CC-486/pembrolizumab in NSCLC and BC

• Ph II demcizumab in PanC

I&I • Endoscopy data with GED-0301 in CD

• Ph II OTEZLA® in AD and UC

• Ph II CC-220 in SLE

• Ph II RPC-4046 in EoE

• Ph II GED-0301 in UC

• Ph II ozanimod in CD

• Ph II sotatercept in renal anemia

• Ph I CC-90001 in IPF

2016 Anticipated Milestones

Regulatory Submissions/Decisions Submit REVLIMID® in US and EU for maintenance post-ASCT Submit POMALYST® renal impairment data in US and EU 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 ph III trial with AG-120 in IDH1 mutant AML Initiate pivotal trial with CC-122 in NHL Initiate ph III trial with OTEZLA® in AD Initiate second ph III trial with GED-0301 in adults Initiate ph III trial with RPC-4046 in EoE

Financial Performance Total Net Product Sales between $10.5 to $11.0 billion Net REVLIMID® sales between $6.6 to $6.7 billion Adjusted operating margin of ~53.5% Adjusted EPS between $5.50 to $5.70

34

Clinical Data Ph III REMARC – REVLIMID® in DLCBL maintenance Ph III CONTINUUM® – REVLIMID® in CLL maintenance 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 RPC-4046 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

1/28/2016

18

Q4 and Full-Year 2015 Conference Call

January 28, 2016

Reconciliation Tables

1/28/2016

19


37

2015

2014

2015

2014

Net p

roduct

sales

2,539.

2$

2,054.

9$

9,161.

1$

7,563.

8$

Othe

r reven

ue24.

1

30.

6

94.

9

10

6.6

To

tal rev

enue

2,563.

3

2,085.

5

9,256.

0

7,670.

4

Cost o

f good

s sold

(excl

uding

amort

ization

ofac

quired

intan

gible

assets

)105

.4

103

.2

420

.1

38

5.9

Re

search

and d

evelop

ment

776.8

584.9

3,697.

3

2,430.

6

Sellin

g, gen

eral an

d adm

inistra

tive609

.1

544

.4

2,3

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27.9

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63.

6

279

.0

25

8.3

Ac

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on rel

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harge

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cturin

g, net

83.7

37.7

299.6

48.7

Total

costs

and e

xpens

es1,6

63.1

1,3

33.8

7,0

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ting inc

ome

900.2

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2,254.

6

2,519.

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incom

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31.

1

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2

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(51

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(31

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(17

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come

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et(34

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3.2

48.4

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axes

745.5

710.8

2,023.

5

2,327.

4

Incom

e tax

provis

ion

184.5

96.9

421.5

327.5

Net in

come

561.0

$

613.9

$

1,602.

0$

1,999.

9$

Net in

come p

er com

mon s

hare:

Basic

0.71

$

0.77

$

2.02

$

2.49

$

Dilute

d0.6

9$

0.7

4$

1.9

4$

2.3

9$

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verage

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s:Ba

sic785

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800

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80

2.7

Di

luted

816.5

834.6

824.9

836.0

Decem

ber 31

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r 31,

2015

2014

Balan

ce sh

eet it

ems:

Cash,

cash

equiva

lents

& ma

rketab

le secu

rities

6,551.

9$

7,546.

7$

Total

assets

27,053

.4

17,340

.1

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-term

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n of lo

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ods En

dedDe

cember

31,

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orpor

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ubsid

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are da

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31,

Three

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38

2015

2014

2015

2014

Net in

come -

GAAP

561.0

$

613

.9$

1,602.

0$

1,999.

9$

Befor

e tax a

djustm

ents:

Cost

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-

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25.

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ible as

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(5)88.

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63.6

279

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(gains)

charg

es and

restruc

turing,

net:

Ch

ange in

fair va

lue of

conting

ent co

nsidera

tion(6)

9.3

37.

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(7.9)

48.

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quisitio

n cost

s(7)

66.0

-

297.6

-

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structu

ring ch

arges

(8)8.4

-

9.9

-

Net in

come ta

x adju

stment

s(9)

16.4

(55

.4)

(277.1

)

(263.7

)

Net in

come -

Adjust

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840.2

$

3,8

82.4

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3,0

98.6

$

Net in

come p

er com

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hare -

Adjust

edBa

sic1.2

2$

1.0

5$

4.90

$

3.8

6$

Dilute

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8$

1.0

1$

4.71

$

3.7

1$

In add

ition to

financ

ial inf

ormatio

n prep

ared in

accor

dance

with U

.S. GA

AP, th

is pres

s relea

se als

o cont

ains a

djuste

d fina

ncial m

easure

s that

we be

lieve p

rovide

invest

ors an

d mana

gement

with s

upplem

ental i

nforma

tion re

lating

to oper

ating p

erform

ance a

nd tre

nds tha

t facili

tate

compar

isons

betwe

en per

iods a

nd wit

h resp

ect to

projec

ted inf

ormatio

n. Thes

e adju

sted f

inanci

al meas

ures a

re non

-GAAP

and s

hould b

e con

sidere

d in ad

dition

to, but

not as

a subs

titute f

or, the

inform

ation p

repare

d in ac

cordan

ce wit

h U.S.

GAAP

. We ty

pically

exclu

de cer

tain

GAAP

items

that m

anagem

ent do

es not

believ

e affe

ct our

basic o

peratio

ns and

that do

not m

eet the

GAAP

defin

ition o

f unus

ual or

non-

recurr

ing ite

ms. Ot

her co

mpani

es ma

y defin

e these

measu

res in

differ

ent wa

ys.

Twelv

e-Mont

h Perio

ds End

ed

Decem

ber 31

,

Celge

ne Co

rporat

ion an

d Subs

idiarie

sRe

concili

ation

of GA

AP to

Adjus

ted Ne

t Incom

e(In

millio

ns, ex

cept pe

r shar

e data

)

Three-

Month

Period

s Ende

d

Decem

ber 31

,

1/28/2016

20


39

Explanation of adjustments:(1) Exclude share-based compensation expense totaling $150.2 for the three-month period ended December 31, 2015 and $128.4 for the three-month

period ended December 31, 2014. Exclude share-based compensation expense totaling $576.6 for the twelve-month period ended December 31, 201 and $447.6 for the twelve-month period ended December 31, 2014.

(2) Exclude upfront payment expense for research and development collaboration arrangements.(3) Exclude in-process research and development (IPR&D) impairment recorded as a result of changes in estimated probability-weighted cash flows

related to CC-292.(4) Exclude settlement of a contingent obligation to make matching contributions to a non-profit organization.(5) 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).(6) Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila, Nogra Pharma Limited and

Quanticel.(7) Exclude equity compensation and other fees and costs related to the acquisitions of Receptos, Inc. and Quanticel.(8) Exclude restructuring charges related to our relocation of certain operations into our two Summit, NJ locations as well as costs associated

with certain headcount reductions.(9) 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, adjustments related to the gain on the sale of an equity investment and nonrecurring items connected with the launch of new products.


40

Low

High

Low

High

Projec

ted ne

t incom

e - GA

AP(1)

804.5

$

859.9

$

3,5

17.8

$

3,8

27.7

$

Befor

e tax a

djustm

ents:

Cost o

f good

s sold

(excl

uding

amort

ization

of ac

quired

intang

ible as

sets):

Shar

e-base

d com

pensat

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pense

8.1

7.9

38.

7

36.

8

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rch an

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nt: S

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ased c

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6

63.

4

307

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292

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Selling

, gener

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: S

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ased c

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3

74.

7

362

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344

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Amo

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cquired

intang

ible as

sets

97.1

88.7

388.4

354.8

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relate

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ges an

d rest

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t: C

hange

in fair

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tingent

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n37.

2

33.

6

136

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123

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estruc

turing

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es10.

0

5.0

30.0

15.0

Net in

come ta

x adju

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s(56

.4)

(67

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(24

3.8)

(29

1.7)

Projec

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t incom

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justed

1,041.

4$

1,066.

0$

4,537.

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4,702.

5$

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diluted

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re - G

AAP

0.98

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1.05

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4.64

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re - A

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5.5

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Projec

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ares

820.0

820.0

825.0

825.0

(1)Ou

r proje

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016 ea

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do not

includ

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ffect o

f any

busine

ss com

binatio

ns, co

llabora

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reeme

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asset a

cquisit

ions, i

ntangi

ble as

set im

pairm

ents, o

r chan

ges in

the fa

ir valu

e of o

ur CV

Rs iss

ued as

part o

f the

acquis

ition o

f Abra

xis tha

t may

occur

after

the da

y prior

to the

date o

f this p

ress re

lease.

Celge

ne Co

rporat

ion an

d Sub

sidiar

iesRe

concili

ation

of 20

16 Pr

ojecte

d GAA

P to A

djuste

d Net

Incom

e(In

millio

ns, ex

cept pe

r shar

e data

)

Three

-Mont

h Perio

d Endi

ngTw

elve-M

onth P

eriod E

nding

March

31, 20

16De

cember

31, 20

16

1/28/2016

21

Appendix

Celgene Pipeline

42

1/28/2016

22

Celgene Pipeline

43

Celgene Pipeline

44

1/28/2016

23

Celgene Pipeline

45

REVLIMID® Multiple Myeloma Late Stage Programs

Patient Population Maintenance Post-VMP induction

Trial NameMM-026

ARUMM

Phase III

Target Enrollment 350

Design

2:1 randomization

Induction with Melphalan/prednisone/bortezomib (VMP) for 6-9 cycles

Arm A: REVLIMID® (10mg) d 1-21 for 28-day cycle

Arm B: Placebo d 1-21 for 28-day cycle

Primary Endpoint Progression Free Survival

Status Trial enrolling

46

1/28/2016

24

REVLIMID® Multiple Myeloma Late Stage Programs

Patient Population Maintenance in ASCT Eligible

Trial 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 to

Arm 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 cycles

Arm B: No treatment

All 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


47

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

progression

Arm B: Bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to disease progression


Status Trial enrolling; Data in 2018E

48

1/28/2016

25

MDS/AML/MF Late Stage Programs

Patient Population Low risk/INT-1 transfusion-dependent MDS Elderly Newly Diagnosed AML

MoleculeCC-486

(Oral Azacitidine)

VIDAZA®

(azacitidine)

Trial Name AZA-MDS-003 AZA-AML-001

Phase III III

Target Enrollment 386 488

DesignArm A: CC-486 (150mg or 200mg)

Arm B: Placebo

Arm A: VIDAZA®

(75 mg/m2 SC) daily for D1-7 of a 28-day cycle until disease progression

Arm B: Conventional Care Regimen (intensive chemotherapy, low-dose cytarabine or best supportive

care) to disease progression

Primary Endpoint RBC-transfusion independence for more than 12 weeks Overall Survival

Status Trial enrollingData presented at EHA 2014 and ASH 2014

Approved in EU Dec 2015

49


Patient Population Post induction AML Maintenance Anemia in to Very Low-, Low-, or Intermediate-Risk MDS

MoleculeCC-486

(oral azacitidine)Luspatercept

Trial Name CC-486-AML-001 MEDALISTTM

Phase III III


DesignArm A: CC-486 (150mg or 200mg)

Arm B: Best Supportive Care

Arm A: Luspatercept (Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks

Arm B: Placebo (Subcutaneous injection every 3 weeks)

Primary Endpoint Overall Survival Red Blood Cell Transfusion Independence (RBC-TI) ≥ 8 weeks

Status Trial enrolling Trial enrolling

50

1/28/2016

26


Patient Population Red Blood Cell Transfusion Dependent Beta-Thalassemia IDH2 Mutant AML

Molecule Luspatercept AG-221 (CC-90007)

Trial Name BELIEVETM IDHENTIFYTM

Phase III III


DesignArm A: Luspatercept (1mg/kg plus Best Supportive

Care

Arm B: Placebo plus Best Supportive Care

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

Arm B: Best supportive care

Primary Endpoint

Proportion of subjects with hematological improvement from Week 13 to Week 24 compared

to 12-week prior to randomization

Hematological improvement from Week 13 to Week 24 compared to the 12-week.

Overall survival

Status Trial enrolling Trial enrolling

51

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 cycle

Arm B: Placebo

Primary Endpoint Overall Survival and ProgressionFree Survival

StatusTrial enrolling

Data in 2016E

52

1/28/2016

27

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

Design

Arm A: REVLIMID® D1-21 of 28-daycycle for 24 months

Arm B: Placebo D1-21 of 28-daycycle 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 cycles

Arm B: Physician’s choice of rituximab-CHOP, rituximab-CVP or rituximab-bendamustine

Primary Endpoint Progression Free Survival Complete Response Rate and Progression Free Survival

StatusEnrollment complete

Data in 2016E

Enrollment complete

Data in 2017E

53


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

Trial NameAUGMENTTM

NHL-007

ROBUST®

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 cycles

Arm 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


Data in 2017ETrial enrolling

54

1/28/2016

28


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



55

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 cycles

Maintenance:

Arm A: ABRAXANE® (100 mg/m2) D 1 and 8 plus BSC until disease progression –

21-day cycle

Arm 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 enrollingTrial enrolling

Data in 2017E

56

1/28/2016

29

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-001

NSCL-003

Abound.sqm®

Phase II/III III

Target Enrollment 240/550 260

Design

Phase II

Arm A: ABRAXANE® 1(25mg/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 cycle

Arm C: Gemcitabine (1000 mg/m2) / Carboplatin AUC 2 IV, D 1 and 8 – 21-day cycle

Phase III

Arm 1: Selected phase II ABRAXANE® arm

Arm 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

Status Trial enrollingTrial enrolling

Data in 2017E

57

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-002

RELIEFTM

Phase III III


DesignArm A: OTEZLA® single agent (30mg)

twice daily

Arm B: Placebo

Arm A; Placebo for 12 weeks followed by 30mg OTEZLA® twice daily for 52-weeks

Arm 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


Data in 2016E

Trial enrolling

Data in 2017E

58

1/28/2016

30


Patient Population Active Crohn’s Disease Active Crohn’s Disease

Molecule GED-0301 GED-0301

Trial Name CD-002 CD-003

Phase III III

Target Enrollment 1,064 1,300

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: 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

Primary Endpoint Clinical remission defined by Crohn's Disease Activity Index (CDAI)

Clinical remission defined by Crohn's Disease Activity Index (CDAI)

StatusEnrolling

Data in 2018E

Enrolling

Data in 2018E

59


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 weekly

Arm B: Ozanimod (1mg) daily/placebo IM weekly

Arm C: Oral placebo daily/Beta-interferon IM weekly

Phase II

Arm A: Ozanimod (0.5mg) daily

Arm B: Ozanimod (1mg) daily

Arm C: Placebo daily

Phase III

Arm A: Ozanimod (0.5mg) daily/placebo IM weekly

Arm 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 H1:17

Enrollment complete

Data expected in H1:17

60

1/28/2016

31


Patient Population Moderate to Severe Ulcerative Colitis

Molecule Ozanimod

Trial Name TRUE NORTH

Phase III


DesignArm A: Ozanimod 1mg (daily for induction and maintenance)

Arm B: Placebo (induction and maintenance)

Primary Endpoint

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 2018E

61

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