q2 2015 conference call€¦ · this presentation contains forward-looking statements, which are...

Q2 2015 Conference CallJuly 23, 2015

Attendees

Bob Hugin, Chairman & Chief Executive Officer

Peter Kellogg, Chief Financial Officer

Jackie Fouse, President, Global Hematology & Oncology

Scott Smith, President, Global I&I

M k All P id t & Chi f O ti Offi

Q&A

Mark Alles, President & Chief Operating Officer

2

Q&A

Forward Looking Statements and Adjusted Financial Information

This presentation contains forward-looking statements, which are generally statements that are nothistorical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,”“believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking, , , p , , p gstatements are based on management’s current plans, estimates, assumptions and projections, andspeak only as of the date they are made. We undertake no obligation to update any forward-lookingstatement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict andare generally beyond our control Actual results or outcomes may differ materially from those impliedare generally beyond our control. Actual results or outcomes may differ materially from those impliedby the forward-looking statements as a result of the impact of a number of factors, many of whichare discussed in more detail in our Annual Report on Form 10-K and our other reports filed with theSecurities and Exchange Commission.

In addition to financial information prepared in accordance with U.S. GAAP, this presentation alsocontains adjusted financial measures that we believe provide investors and management withsupplemental information relating to operating performance and trends that facilitate comparisonsbetween periods and with respect to projected information. These adjusted financial measures arenon-GAAP and should be considered in addition to but not as a substitute for the informationnon GAAP and should be considered in addition to, but not as a substitute for, the informationprepared in accordance with U.S. GAAP. We typically exclude certain GAAP items thatmanagement does not believe affect our basic operations and that do not meet the GAAP definitionof unusual or non-recurring items. Other companies may define these measures in different ways.Further information relevant to the interpretation of adjusted financial measures, and reconciliations

f th dj t d fi i l t th t bl GAAP b f d

3

of these adjusted financial measures to the most comparable GAAP measures, may be found onCelgene’s website at www.Celgene.com in the “Investor Relations” section.

Additional Information on the Tender Offer

The acquisition of Receptos will be accomplished through a tender offer that has not yet commenced. The description contained herein is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any shares of Receptos. At the time the tender offer is y y pcommenced, Celgene and its wholly owned subsidiary, Strix Corporation, intend to file with the U.S. Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and Receptos intends to file a Solicitation/Recommendation Statement on Schedule 14D 9 with respect to the tender offer Celgene Strix Corporation and Receptos intend to mail14D-9 with respect to the tender offer. Celgene, Strix Corporation and Receptos intend to mail these documents to the stockholders of Receptos.

THESE DOCUMENTS, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER AND RECEPTOS STOCKHOLDERS ARE URGED TO READ THEM CAREFULLY WHEN THEY BECOME AVAILABLE.

Stockholders of Receptos will be able to obtain a free copy of these documents (when they become available) and other documents filed by Receptos Celgene or Strix Corporation with the SEC at theavailable) and other documents filed by Receptos, Celgene or Strix Corporation with the SEC at the website maintained by the SEC at www.sec.gov. In addition, stockholders will be able to obtain a free copy of these documents (when they become available) from the information agent named in the offer to purchase or from Celgene.

4

Bob Hugin

Q2 2015: Exceptional Results; Continued Investment for Future Growth

Strong top and bottom line growth

Outstanding Financial ResultsOutstanding Financial Results– Strong top- and bottom-line growth – Continued operating momentum into H2:15– 2015 adjusted EPS guidance raised; 2020 targets increased

– Growth of key products driven by increased market share and duration– 6 significant global regulatory approvals across the portfolio in H1:15

Strong Performance Across All Operating MetricsStrong Performance Across All Operating Metrics

6 significant global regulatory approvals across the portfolio in H1:15– Advanced 5 new agents into the clinic in H1:15

Investing in Next Generation Growth DriversInvesting in Next Generation Growth Drivers

– 4 INDs filed in H1:15– AstraZeneca/MEDI and Juno Therapeutics collaborations enhance pipeline– Receptos acquisition creates future industry-leading immune-inflammatory franchise

gg

6

– Receptos acquisition creates future industry-leading immune-inflammatory franchise

Juno and Receptos transactions subject to completion.

Peter Kellogg

Q2 2015 Financial Highlights

E ceptional Q2 Res lts Across the PortfolioE ceptional Q2 Res lts Across the PortfolioExceptional Q2 Results Across the PortfolioExceptional Q2 Results Across the Portfolio

Strong Execution on New Product ApprovalsStrong Execution on New Product Approvals

Investment in Next-Generation Growth DriversInvestment in Next-Generation Growth Drivers

Executing a Balanced Capital Allocation StrategyExecuting a Balanced Capital Allocation Strategy

8

Executing a Balanced Capital Allocation Strategy Executing a Balanced Capital Allocation Strategy

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

$2,254

$1 564$1,845

$2,254

s $1,564

$ M

illio

ns

↑17% ↑18% ↑22%

Q2:13 Q2:14 Q2:15

9

Volume Drove Q2 2015 Growth

Contribution to Q2:15 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)

$2 000

↑22.2%↓2.0%↑21.7% ↑2.5%

$1,500

$2,000

llion

s

$1,000

$ M

i

$0

$500

$0Q2:14 Volume Price Fx / Hedge Q2:15

10

Worldwide Net Product Sales

Net Product Sales(in $ Millions) Q2:15 ∆ vs.

Q2:14∆ vs.Q1:15

REVLIMID® Total $1 444 ↑19% ↑8%REVLIMID® Total $1,444 ↑19% ↑8%U.S. $873 ↑22% ↑8%International $571 ↑15% ↑7%

ABRAXANE® Total $244 ↑13% ↑9%ABRAXANE Total $244 ↑13% ↑9%U.S. $170 ↑6% ↑7%International $74 ↑34% ↑16%

POMALYST®/IMNOVID® Total $235 ↑46% ↑18%U.S. $144 ↑38% ↑12%International $91 ↑60% ↑30%

VIDAZA® Total $152 0% ↑6%U.S. $6 ↓42% ↓5%International $146 ↑3% ↑6%

OTEZLA® Total $90 NA ↑49%Other Total $89 ↓9% ↑4%

11

Other Total $89 ↓9% ↑4%

Total Net Product Sales $2,254 ↑22% ↑10%

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

$1 23

$0 90

$1.23

e

$0.76$0.90

Per S

hare

↑25% ↑18%Dol

lars

↑37%

Q2:13 Q2:14 Q2:15

12

Footnote: Adjusted EPS is split-adjusted for Q2:13

Key P&L Line Items (Adjusted)

Q2:15 H1:15 ∆ vs. ∆ vs. ∆ vs.Q2:15 H1:15 Q2:14 Q1:15 H1:14

Product Gross Margin 95.9% 95.6% ↑90 bps ↑60 bps ↑50 bps

R&D expenses% of revenue

$477M 20.9%

$908M 20.8%

↓30 bps ↑20 bps ↓20 bps

SG&A expenses $541M $1,004MSG&A expenses% of revenue

$541M 23.7%

$1,004M 23.0%

↑20 bps ↑140 bps ↓80 bps

Operating Margin 51.3% 51.8% ↑100 bps ↓110 bps ↑140 bps

Effective Tax Rate 16.7% 16.2% ↑70 bps ↑100 bps ↓10 bps

13

Q2 2015 Adjusted Diluted EPS Growth Driven by Increased Operating Income

Contribution to Q2:15 Adjusted Diluted EPS

$1.23$0.23$0.90 $0.01 $0.01$0.08

Shar

eD

olla

rs P

er

Q2:14 Operating Financial Tax Rate Share Q2:15

D

Q p gIncome Income /

ExpenseCount

Q

14

Cash and Marketable Securities

(in Billions) 6/30/15 12/31/14(in Billions) 6/30/15 12/31/14

Cash and Marketable Securities $7.49 $7.55

• Cash flow from operations was approximately $284M during Q2:15

• In Q2:15, purchased $902M of shares; In H1:15, purchased $2 034M of sharespurchased $2,034M of shares– Reauthorized additional $4B for share repurchases– $5.1B remaining under stock repurchase program at 6/30/15

15

Focused on Returns

35 0%$16 0

ROIC

25.0%

30.0%

35.0%

$12.0

$14.0

$16.0

15.0%

20.0%

25.0%

$8.0

$10.0

illio

n

5.0%

10.0%

$2.0

$4.0

$6.0

$ B

i

Average Invested Capital0.0%$0.0

2009 2010 2011 2012 2013 2014 2015 (TTM)

Capital Base Excluding Cash* Capital Base ROIC Excluding Cash* ROIC

Average Invested Capital

Cap ta ase c ud g Cas Cap ta ase O C c ud g Cas O C

16

* For purposes of this calculation, cash includes cash and cash equivalents and marketable securities available for sale.

Footnote: Refer to reconciliation tables for ROIC calculation methodology. Calculation revised in 2015 for all prior periods to reflect amortization of certain charges excluded from 2008 calculation.

Q2 2015 Summary

Q2 P f D i b S l V l G th d O ti LQ2 P f D i b S l V l G th d O ti LQ2 Performance Driven by Sales Volume Growth and Operating LeverageQ2 Performance Driven by Sales Volume Growth and Operating Leverage

Q1 Global Approvals Began to Contribute in Q2Q1 Global Approvals Began to Contribute in Q2

Investments in Next-Generation Growth Drivers On-GoingInvestments in Next-Generation Growth Drivers On-Going

Raised 2015 Adjusted EPS Guidance to $4.75 to $4.85*Raised 2015 Adjusted EPS Guidance to $4.75 to $4.85*

17

j $ $j $ $

* Adjusted EPS assumes closing of Juno and Receptos transactions.

Jackie Fouse

Q2 2015 Hematology & Oncology Franchise Results

– Q2:15 net sales growth of 18% Y/Y; 9% Q/Q

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

g ;– Excellent results from REVLIMID® and POMALYST®/IMNOVID®

2015 P d t G th D i O T k2015 P d t G th D i O T k– Strong uptake in the U.S. with REVLIMID® in NDMM– Progress with key markets reimbursement for REVLIMID® NDMM,

2015 Product Growth Drivers On-Track2015 Product Growth Drivers On-Track

ABRAXANE® PanC and POMALYST®/IMNOVID® in RRMM– POMALYST® approval and launch in Japan

– Advancing hematology clinical development plan for durvalumab– Juno Therapeutics collaboration complements emerging best-in-class

Investing in Next Generation Growth DriversInvesting in Next Generation Growth Drivers

19

Juno Therapeutics collaboration complements emerging best in class immuno-oncology pipeline

Juno transaction subject to completion.

Q2 2015 REVLIMID® Net Sales Summary

Current Results & Future Growth DriversCurrent Results & Future Growth Drivers

• Q2:15 sales $1,444M; +19% Y/Y, +8% Q/QSales ($M)

$$1,444, ; ,

• Strong U.S. Q2 TRx and NRx trends• Market shares and duration of treatment are

strong across the world$540 $525

$532 $571

$1,300 $1,322 $1,343

• Progress on 2015 commercial drivers– On-track with NDMM reimbursement

discussions in EU; EU G5 by Q1:16– Execution of launch for NDMM in U.S. and EU

R i F d l RRMM i b i Q2

$540 $525

– Russia Federal RRMM reimbursement in Q2– Data at ASCO to support the evolving triplet

regiment landscape with REVLIMID® as backbone

• Future growth drivers advancing$760 $797 $811 $873

Future growth drivers advancing Geographic expansion in Latin America

continues Updates at ASCO and EHA on MM-020

survival data and “FLASH” meta-analysis in FL Q3:14 Q4:14 Q1:15 Q2:15

20

NDMM approval in Japan by YE15U.S. ROW

Q2 2015 POMALYST®/IMNOVID® Sales Summary


$202

$235

• Q2:15 sales $235M; +46% Y/Y 18% Q/QSales ($M)

$70 $70

$91 $181

$202 $199• Q2:15 sales $235M; +46% Y/Y,18% Q/Q

• Positive trends in U.S. and EU market share

• Progress on 2015 growth drivers$63

Progress on 2015 growth drivers Reimbursement in Italy; Finland, Ireland

and Netherlands expected in Q3 Launch in Japan has begun

Strong growth in Canada; Launching in

$118 $132 $129 $144

Strong growth in Canada; Launching in Australia

• Future growth drivers advancing U.S. label update with OS

Q3:14 Q4:14 Q1:15 Q2:15

p Phase II trials with checkpoint inhibitors,

HDAC inhibitors, proteasome inhibitor enrolling

21

U.S. ROW

Q2 2015 ABRAXANE® Sales Summary


• Q2:15 sales $244M; +13% Y/Y 9% Q/QSales ($M)

$64 $74 $212

$236$223

$244Q2:15 sales $244M; +13% Y/Y, 9% Q/Q

• Continued growth in U.S. and EU in pancreatic cancer

• Progress on 2015 growth drivers$61

$$64• Progress on 2015 growth drivers

EU launch in pancreatic cancer continues to expand; Reimbursement expected in H2 in France and PortugalReimbursement secured in Q1 in Spain

$151 $172 $159 $170

Reimbursement secured in Q1 in Spain and Italy; Launching in Q2

Launching in Germany and Austria for NSCLC in early access markets

Q3:14 Q4:14 Q1:15 Q2:15

• Future growth drivers advancing Combination phase III trials with PD-L1

in NSCLC and TNBC enrolling

22

U.S. ROW

Strong Current Performance;Bright Future

18% Y/Y net product sales growth for Hematology/Oncology in Q2:15

Strong Operating Momentum

18% Y/Y net product sales growth for Hematology/Oncology in Q2:15 Exceptional growth across the portfolio

Advancing Near Term Growth Drivers

Positive trends for REVLIMID® NDMM in U.S. and early markets in EU IMNOVID® market share in EU showing strong growth

Advancing Near-Term Growth Drivers

g g g ABRAXANE® U.S. pancreatic cancer market share in MPACT population ~50%

Key Data Inflection Point Over Next 24 MonthsKey Data Inflection Point Over Next 24 Months

Data read outs from REVLIMID® lymphoma trials beginning in 2017 Progress on label expansion with ABRAXANE® in NSCLC, adjuvant PanC and

TNBC; Data expected beginning in 2016

Key Data Inflection Point Over Next 24 MonthsKey Data Inflection Point Over Next 24 Months

23

TNBC; Data expected beginning in 2016 Trials with ABRAXANE® I/O combinations advancing

Scott Smith

Q2 2015 I&I Franchise Updates

Strong U.S. Sales and Global Launch Advancing for OTEZLA®Strong U.S. Sales and Global Launch Advancing for OTEZLA®

– Market dynamics continue to favor OTEZLA® utilization– EU launch trends accelerating– Launch underway across North America and Europe

Accelerating OTEZLA® Growth DriversAccelerating OTEZLA® Growth Drivers

– Increasing brand awareness (i.e., U.S. growth drivers) through DTC– Expanding geographic footprint and lifecycle applications

– Initiating phase III trials for GED-0301

Investing in Next-Generation Growth DriversInvesting in Next-Generation Growth Drivers

25

– Receptos transaction announced

Accelerating Prescription and Revenue Growth

U.S. Weekly TRx

4 0004,5005,000

2014 2015 Sales ($M)

1,5002,0002,5003,0003,5004,000

$5

0500

1,000,

1 14 27 40 53 66Weeks Since Product Launch

OTEZLA (P A/PSOR) SIMPONI (RA/P A/AS) XELJANZ (RA)

$1

Germany Monthly TRx

OTEZLA (PsA/PSOR) SIMPONI (RA/PsA/AS) XELJANZ (RA)CIMZIA (Crohn's) STELARA (PsO)

1,000 $47$59

$85

0

500

1 2 3 4 5Months Since Product Launch

$5$18

Q2:14* Q3:14 Q4:14 Q1:15 Q2:15

Note: STELARA TRx launch aligned based on 4 week trailing average; TRx reflects total number of new and refill prescriptions to-date;Source: IMS SMART data; through week ending 17 July 2015. *Partial quarter

26

Months Since Product Launch

OTEZLA (PsA/PSOR) SIMPONI (RA/PsA/AS) CIMZIA (RA) STELARA (PsO)

Q2:14 Q3:14 Q4:14 Q1:15 Q2:15U.S. ROW

Psoriasis Market Dynamics SupportingPositive U.S. Launch Performance

• Revenue and prescription growth on strong trajectory• Execution of multi-channel consumer and physician campaign drivingExecution of multi channel consumer and physician campaign driving

increase in brand awareness, patient requests and number of trialists• Majority (note >70%) of OTEZLA® Rx’s in pre-biologic patients

approved on first passapproved on first pass

Psoriasis Source of Business(based on last therapy prior to OTEZLA®*)

Total U.S. Patient Share in Psoriasis(based on last therapy prior to OTEZLA® )

14%30%

Biologic

Oral S stemic15%

20%

25%

30%

35%

10%

45%

Oral Systemic

Topical

Naïve (No tx in prior 12 months)

0%

5%

10%

15%

27

HUMIRA COSENTYX ENBREL STELARA OTEZLA

Note: Symphony data is subject to restatement. * Based on 12-month windowSource: comScore, Symphony Prescriber-level data through week ending 5 June 2015; SHA PTD claims data (May ‘15 feed for month ending March '15)

Transformational I&I Pipeline

Multiple Potential Blockbuster Products in I&IMultiple Potential Blockbuster Products in I&I

Significant Growth through 2020 and

beyondOzanimod* beyondOzanimodUC

2019E

GED-0301

Ozanimod*RMS

2018E

CD2019E

OTEZLA®

PsA / Psor2014

2018E

Celgene existing Receptos

28

1 Under co-development option with AbbVie

* Receptos transaction subject to completion.

Comprehensive Development ProgramUnderway for GED-0301

CD 001 E d i ( 48)CD 001 E d i ( 48)

20142014 20152015 20162016 20172017 20182018 20192019

CD-002: 52 Week (n=1,100) CD-002: 52 Week (n=1,100)

CD-001: Endoscopic (n=48)CD-001: Endoscopic (n=48)

CD-003: 52 week (n=900)CD-003: 52 week (n=900)

CD-006: Adolescent population (n=250)CD-006: Adolescent population (n=250)

UC Phase II trial (n=152)UC Phase II trial (n=152)

• CD-001 progressing as planned; complete enrollment targeted mid-year 2015CD 001 progressing as planned; complete enrollment targeted mid year 2015• Phase III registration trials on schedule for initiation H2:15• Phase II proof of concept study in ulcerative colitis on schedule for

initiation H2:15

29

initiation H2:15• Preparations ongoing for adolescent study; initiation YE15 / H1:16

Advancing and Expanding Blockbuster Development Opportunities in I&I

Strong operating momentum to further enhance current revenue trajectory

Maximizing the OTEZLA® Opportunity

Strong operating momentum to further enhance current revenue trajectory Activities underway to drive increased awareness, access and usage Preparing for next wave of global launches and indication expansions

Completing enrollment of registration enabling endoscopy trial in Crohn’s disease

Moving GED-0301 Forward

Completing enrollment of registration-enabling endoscopy trial in Crohn s disease Initiating Ph III trials of GED-0301 in adults and adolescents with Crohn’s disease Initiating clinical program in ulcerative colitis

Potential for Ozanimod in ulcerative colitis and multiple sclerosis

New Products Furthering the I&I PipelineNew Products Furthering the I&I Pipeline

30

p Advancing CC-220 and sotatercept trials in multiple indications

Receptos transaction subject to completion.

Mark Alles

Key Milestones – Full-Year 2015

Franchise Milestone ExpectedTiming

Regulatory decisions on REVLIMID® for NDMM in the U.S. and EU Feb 2015

Regulatory decision on REVLIMID® for NDMM in Japan H2Regulatory decision on REVLIMID for NDMM in Japan H2

Submit REVLIMID® for non-del5q MDS in U.S. and Japan 2015

Presentation of FLASH meta-analysis on durable CR in follicular NHL Jun 2015

Initiate enrollment in REVLIMID® Ph III ROBUST trial in DLBCL Jan 2015

EU regulatory decision on ABRAXANE® in NSCLC Mar 2015

Regulatory decision on POMALYST® for RRMM in Japan Mar 2015

Complete enrollment in REVLIMID® Ph III CONTINUUM trial in CLL H2

CHMP opinion on VIDAZA® for elderly AML H2

Hematology& Oncology

CHMP opinion on VIDAZA® for elderly AML H2

Advance CC-122 in Ph I/II trials in DLBCL H2

Initiate luspatercept in Ph III trial in beta-thalassemia H2

Initiate Ph III trial with AG-221 in AML with IDH-2 mutation H2

EU regulatory decision on OTEZLA® in PSOR and PsA Jan 2015

Complete enrollment in GED-0301 registration-enabling endoscopy trial H2

Initiate enrollment in GED-0301 Ph III trials in Crohn’s disease H2

Initiate GED 0301 clinical program in ulcerative colitis H2I & I

Initiate GED-0301 clinical program in ulcerative colitis H2

Complete enrollment in CC-220 Ph II trial in SLE H2

Completion of Receptos acquisition H2

32

Q2 2015 Conference CallJuly 23, 2015

Reconciliation Tables


2014 3,5

52.1

$

50.

6

3,602.

7

185.0

1,1

70.6

985

.9

131.0

9.5

2,482.

0

1,1

20.7

13.7

(70

.9)

(24.4)

1,0

39.1

161.6

877

.5$

1.09

$

1.0

5$

805.5

838

.0

Perio

ds En

dede 3

0,201

4201

5

1,844.

6

4,309.

3$

28.1

49.3

1,872.

7

4,358.

6

98.9

204.8

456.9

1,616.

0

491.8

1,146.

0

65.3

127.3

0.9

(10

.3)

1,1

13.8

3,0

83.8

758.9

1,274.

8

7.3

17.

8

(41

.6)

(97

.5)

(17

.8)

102

.8

706.8

1,297.

9

109.0

222.8

597.8

1,0

75.1

$

0.75

1.35

$

0.72

1.30

$

799.6

796.0

831.0

829.7

mber

31,201

4 7,546.

7 17,

340.1

605

.9

6,265.

7 6,5

24.8

Six-M

onth P Jun

e

me Ended

2015

2

2,254.

1$

$

23.

7

2,2

77.8

100.8

1,110.

0

616.8

63.7

(29.3)

1,862.

0

415.8

8.8

(48.3)

94.5

470.8

114.6

356.2

$

$

0.45

$

$

0.4

3$

$

793.0

825.3

June 3

0,De

cem201

52

7,492.

2$

$

17,

745.7

1,3

62.9

6,2

56.1

6,3

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on an

d Sub

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tatem

ents

of Inc

o mud

ited)

pt per

share

data)

June 3

0,Th

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n of lo

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ate (Unau

(In m

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s, exce

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amort

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debt

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ty

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reven

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s sold

acquir

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costs a

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Other

incom

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Net in

come

Net in

come p

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Basic

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d

Balan

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eet it

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cash

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etsSh

ort-te

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Long-

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dTo

tal sto

ckh


2014

75.1

877.5

$

4.812

.0

9.892

.8

88

.532

3.0

41.9

103.0

-25

.0

27.3

131.0

0.3)

9.5

47.3)

(121.0

)

09.8

1,452

.8$

2.40

1.80

$

2.30

1.73

$

three

-mon

th pe

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d $20

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imite

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t tha

t fac

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uld be

ex

clude

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on-

onth

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ds E

nded

June

30,

2014

2015

597.8

1,0

7$

5.9

1

45.8

11

14.0

5 8

51.7

1 4

-

65.3

1 2

0.9

(1

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74

7.9

1,90

$

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2

$

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2

$

e 30,

2015

and $

103.4

for t

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nth pe

riod e

nded

June

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01

izatio

n.er

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aceu

ticals

, Inc.

(Glou

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adjus

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Return on Invested Capital CalculationReturn on Invested Capital (ROIC)(amounts in thousands) Q2 2015 (TTM) 2014 2013 2012 2011 2010 2009Operating income 2,673,100 2,519,000 1,808,900 1,746,442 1,442,753 989,635 841,526

Certain charges (1)Amortization of certain charges (2) (141,000) (141,000) (141,000) (261,000) (141,000) (141,000) (141,000)

Operating income (non-GAAP for 2008) 2,532,100 2,378,000 1,667,900 1,485,442 1,301,753 848,635 700,526

Effective tax rate 15.0% 14.1% 12.9% 13.4% 7.2% 13.1% 20.4%O ti i ft t 2 151 531 2 043 380 1 452 284 1 286 401 1 208 155 737 660 557 681Operating income after tax 2,151,531 2,043,380 1,452,284 1,286,401 1,208,155 737,660 557,681

Total equity 6,321,863 6,524,796 5,589,900 5,694,467 5,512,727 5,995,472 4,394,606 Certain charges net of amortization (3) 778,086 914,699 1,051,313 1,187,927 1,440,807 1,577,420 1,714,034 Total debt 7,619,051 6,871,632 4,741,269 3,079,792 1,802,269 1,247,584 -

Total capital 14,718,999 14,311,127 11,382,482 9,962,186 8,755,803 8,820,476 6,108,640

Total capital beginning of period 12,769,846 11,382,482 9,962,186 8,755,803 8,820,476 6,108,640 5,341,976 Total capital end of period 14 718 999 14 311 127 11 382 482 9 962 186 8 755 803 8 820 476 6 108 640Total capital end of period 14,718,999 14,311,127 11,382,482 9,962,186 8,755,803 8,820,476 6,108,640

Average total capital 13,744,423 12,846,805 10,672,334 9,358,994 8,788,140 7,464,558 5,725,308

ROIC 15.7% 15.9% 13.6% 13.7% 13.7% 9.9% 9.7%

Return on Invested Capital (ROIC), Net of Cash(amounts in thousands) Q2 2015 (TTM) 2014 2013 2012 2011 2010 2009Operating income 2,673,100 2,519,000 1,808,900 1,746,442 1,442,753 989,635 841,526

Certain charges (1)Amortization of certain charges (2) (141,000) (141,000) (141,000) (261,000) (141,000) (141,000) (141,000)

Operating income (non-GAAP for 2008) 2,532,100 2,378,000 1,667,900 1,485,442 1,301,753 848,635 700,526

Effective tax rate 15.0% 14.1% 12.9% 13.4% 7.2% 13.1% 20.4%Operating income after tax 2,151,531 2,043,380 1,452,077 1,286,401 1,208,155 737,660 557,681

Total equity 6,321,863 6,524,796 5,589,900 5,694,467 5,512,727 5,995,472 4,394,606 Certain charges net of amortization (3) 778,086 914,699 1,051,313 1,187,927 1,440,807 1,577,420 1,714,034 Total debt 7 619 051 6 871 632 4 741 269 3 079 792 1 802 269 1 247 584Total debt 7,619,051 6,871,632 4,741,269 3,079,792 1,802,269 1,247,584 - Less Cash and Marketable Securities (7,492,207) (7,546,633) (5,686,989) (3,900,270) (2,648,154) (2,601,301) (2,996,752)

Total capital 7,226,793 6,764,494 5,695,493 6,061,916 6,107,649 6,219,175 3,111,888

Total capital beginning of period 6,556,767 5,695,493 6,061,916 6,107,649 6,219,175 3,111,888 3,119,885 Total capital end of period 7,226,793 6,764,494 5,695,493 6,061,916 6,107,649 6,219,175 3,111,888

Average total capital 6,891,780 6,229,994 5,878,704 6,084,782 6,163,412 4,665,532 3,115,886

ROIC, Net of Cash 31.2% 32.8% 24.7% 21.1% 19.6% 15.8% 17.9%

38

ROIC, Net of Cash 31.2% 32.8% 24.7% 21.1% 19.6% 15.8% 17.9%

(1) Excludes $1.7 billion of IPR&D expense in 2008 associated with the acquisition of Pharmion, as well as $300 millionof expense related to the acquisition of intellectual property rights for Vidaza in 2008 prior to it's launch. (2) Adjustment to include amortization and impairment related to IPR&D and intellectual property rights acquired in 2008.(3) Cumulative net impact of items (1) and (2) on equity.

Appendix

Worldwide Other Net Product Sales

Net Product Sales(in $ Millions)

Q2:15 ∆ vs.Q2:14

∆ vs.Q1:15( )

THALOMID® Total $48 ↓12% ↑2%

U.S. $34 ↓7% ↑4%

International $14 ↓21% ↓3%International $14 ↓21% ↓3%

ISTODAX® Total $18 ↑5% ↑8%

U.S. $17 ↑4% ↑12%

International $1 ↑13% ↓31%International $1 ↑13% ↓31%

Authorized Generic of VIDAZA® Drug Product Total (U.S.) $22 ↓9% ↑8%

Other $1 NA NA

40

Celgene Pipeline

41

Celgene Pipeline

42

Celgene Pipeline

43

Celgene Pipeline

44

REVLIMID® Multiple Myeloma Late Stage Programs

Patient Population Maintenance Post-ASCT Maintenance Post-ASCT

Trial Name CALGB 100104 IFM 2005-02

Phase III III

Target Enrollment 459 614

DesignArm A: REVLIMID® (10mg) until disease

progression Arm B: Placebo until disease progression

Arm A: REVLIMID® consolidation (25mg) for 2 cycles followed by REVLIMID®

(10-15mg) until disease progressionArm B: REVLIMID® consolidation (25mg)

for 2 cycles followed by placebo until disease progressiondisease progression

Primary Endpoint Time to Progression Progression Free Survival

Trial met primary endpoint in Dec 2009Data presented at ASCO 2010. Follow-up

Trial met primary endpoint in June 2010Data presented at ASCO 2010. Follow-up

StatusData presented at ASCO 2010. Follow up

data at ASH 2010, IMW 2011 and IMW 2013 and ASCO 2015.Published in NEJM May 2012

Follow-up for survival continuing

Data presented at ASCO 2010. Follow up data at ASH 2010, IMW 2011 and

ASH 2013.Published in NEJM May 2012

Follow-up for survival continuing

45


Patient Population Maintenance Post-VMP induction

Trial Name MM-026Trial Name MM-026

Phase III

Target Enrollment 350

2 1 d i ti

Design

2:1 randomizationInduction with

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

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

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

Primary Endpoint Progression Free Survival

St t T i l lliStatus Trial enrolling

46


Patient Population Maintenance in ASCT EligibleTrial Name MYELOMA XI

Phase IIIPhase III

Target Enrollment 3,970

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)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 cyclesPatients with no change progressive disease PR or MR randomized toDesign 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 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 Survivaly p g

Status Trial enrolling

47

POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs

Patient Population RRMM

T i l NMM-007

Trial NameOPTIMISMM

Phase III

Target Enrollment 782

D i

Arm A: POMALYST®/IMNOVID® (4mg), bortezomib (1.3 mg/m2 IV) and low-dose dexamethasone to disease progressionDesign dexamethasone to disease progression

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

Primary Endpoint Progression Free SurvivalPrimary Endpoint Progression Free Survival


48

MDS/AML/MF Late Stage Programs

Patient Population Non-del5Q low risk/INT-1 transfusion-dependent MDS

Low risk/INT-1 transfusion-dependent MDS

CC 486Molecule REVLIMID®

CC-486(Oral Azacitidine)

Trial Name MDS-005 AZA-MDS-003

Phase III III

Target Enrollment 239 386g

DesignArm A: REVLIMID® (10mg)

Arm B: PlaceboArm A: CC-486 (150mg or 200mg)

Arm B: Placebo

Primary Endpoint RBC-transfusion independencefor at least 8 weeks

RBC-transfusion independence for more than 12 weeks

Primary endpoint metStatus

yData presented at ASH 2014

Submission to FDA expected in 2015ETrial enrolling

49

MDS/AML/MF Late Stage Programs

Patient Population Elderly Newly Diagnosed AML Post induction AML Maintenance

MoleculeVIDAZA® CC-486

Molecule(azacitidine) (oral azacitidine)

Trial Name AZA-AML-001 CC-486-AML-001

Phase III III


Arm A: VIDAZA®

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

Designcycle until disease progression

Arm B: Conventional Care Regimen (intensive chemotherapy, low-dose

cytarabine or best supportive care) to disease progression

Arm A: CC-486 (150mg or 200mg)Arm B: Best Supportive Care

Primary Endpoint Overall Survival Overall Survival

StatusData presented at EHA 2014 and ASH 2014

S b itt d t EU i 2014Trial enrolling

Submitted to EU in 2014g

50

REVLIMID® Chronic Lymphocytic Leukemia Late Stage Programs

Patient Population Elderly Newly Diagnosed CLL Maintenance in 2nd Line CLL

Trial NameCLL-008 CLL-002

Trial NameORIGIN® CONTINUUM®

Phase III III


D i

Arm A: REVLIMID® (starting dosage 5mg/day escalated to 10mg/day) until disease progression 28 day cycle

Arm A: REVLIMID® (starting dosage 2.5mg/day escalated to 10mg/day) until

Design disease progression – 28-day cycleArm B: Chlorambucil (0.8 mg/kg) D1-15 for

~13 cycles (12 months) of 28-day cycle

g y g y)disease progression - 28-day cycle

Arm B: Placebo

Primary Endpoint Progression Free Survival Overall Survival and ProgressionFree Survivaly p g Free Survival

Status

Enrollment completeTrial put on clinical hold & discontinued

in July 2013Data to be presented at a future

Trial enrollingEnrollment to complete in 2015E

Data to be presented at a future medical congress

51

REVLIMID® Lymphoma Late Stage Programs

Patient PopulationMaintenance in Patients with

DLBCL responding to R-CHOP to induction therapy

Newly Diagnosed Follicular Lymphoma

Trial Name REMARC RELEVANCE®

Phase III III

Target Enrollment 621 1,000

Arm A: REVLIMID® (starting dose 20mg)

DesignArm A: REVLIMID® D1-21 of 28-day

cycle for 24 monthsArm B: Placebo D1-21 of 28-day

cycle for 24 months

D2-22 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

Status Enrollment complete Enrollment completeStatus Enrollment complete Enrollment complete

52


Patient Population Relapsed or Refractory Follicular Lymphoma

Untreated Activated B-Cell DLBCL

T i l NAUGMENTTM ROBUSTTM

Trial NameNHL-007 DLC-002

Phase III III

Target Enrollment 500 560Target 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 cycles Arm a: REVLIMID® (15mg) D1-14/+ R-CHOP21 for 6 21-day cyclesDesign

Arm B: Placebo D1-21, / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of

cycles 2-5 for 5 28-day cycles

CHOP21 for 6 21 day cyclesArm B: Placebo + R-CHOP21 for 6 cycles

Primary Endpoint Progression Free Survival Progression Free Survival

Status Trial enrolling Trial enrolling

53


Patient Population Relapsed or Refractory Indolent Lymphoma

Trial NameMAGNIFYTM

NHL-008

Phase III

T t E ll t 500Target Enrollment 500

D i

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 cycleDesign 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


54

ABRAXANE® Solid Tumor Late Stage Programs

Patient PopulationMaintenance After Induction in

Squamous Non-Small Cell Lung Cancer

Adjuvant Therapy in Surgically Resected Pancreatic Cancer

PANC-003Trial Name NSCL-003

PANC 003APACT

Phase III III


Induction: ABRAXANE® (100 mg/m2) D 1, 8,and 15 / Carboplatin (6 mg min/mL) D 1 for

4 21-day cycles Arm A: ABRAXANE® (125 mg/m2) / Gemcitabine (1000 mg/m2) D 1 8 and 15 for

Design 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

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.

Arm B: BSC until disease progression

Primary Endpoint Progression Free Survival Disease Free Survival


55

ABRAXANE® Solid Tumor Late Stage Programs

Patient Population First-Line Triple Negative Metastatic Breast Cancer

First Line Stage IIIB / IV Squamous NSCLC

tnAcity™ NSCL 003Trial Name

tnAcity™ABI-007-MBC-001

NSCL-003Abound.sqm

Phase II/III III

Target Enrollment 240/550 260Target Enrollment 240/550 260

Phase IIArm A: ABRAXANE® 1(25mg/m2) / Gemcitabine

(1000 mg/m2) D 1 and 8 – 21-day cycleArm B: ABRAXANE® (125mg/m2) / Carboplatin

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

DesignAUC 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 IIIArm 1: Selected phase II ABRAXANE® arm

Maintenance – ABRAXANE® (100 mg/m) D 1 and 8 of a 21-day cycle or Best supportive

careArm B: Induction – ABRAXANE® (100 mg/m2) D 1, 8 and 15 / Carboplatin (6

mg/min/ml) D 1 of a 21-day cycle; pArm 2: Gemcitabine (1000 mg/m2) / Carboplatin

AUC 2 IV, D 1 and 8 – 21-day cycle

g ) y y ;Maintenance – Best supportive care

Primary Endpoint Progression Free Survival Progression Free Survival


56

I&I Late Stage Programs

Patient Population

Untreated Moderate-to-Severe

Late Stage Psoriatic Arthritis

Active Behçet’s DiseaseArthritis

Molecule OTEZLA® OTEZLA®

Trial Name PSA-006BCT-002RELIEFTM

Ph III IIIPhase III III


Arm A: OTEZLA® single agent Arm A; Placebo for 12 weeks followed by 30mg OTEZLA®

Designg g

(30mg)twice daily

Arm B: Placebo

followed by 30mg OTEZLA®

twice daily for 52-weeksArm B: 30mg OTEZLA® twice

daily for 64 weeks

Area under the curve (AUC) forPrimary Endpoint ACR 20 at Week 16

Area under the curve (AUC) for the number of oral ulcers from

baseline through week 12


57

q2 2015 conference call€¦ · this presentation contains forward-looking statements, which are...

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