q3 2013 conference call€¦ · 2013 ∆ vs. q3:12 through sep 2013 ∆ vs. through sep 2012sep...

Q3 2013 Conference CallOctober 24, 2013

Agenda

Patrick Flanigan, VP, Investor Relations

Bob Hugin, Chief Executive Officer

Jackie Fouse, Chief Financial Officer

Mark Alles, Head of Hematology & Oncology

Q&A

Scott Smith, Head of Inflammation & Immunology

2

Q&A

Forward Looking Statements and Adjusted Financial Information

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

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

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

3

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

Bob Hugin

Q3 2013: A Quarter of Outstanding Results

Outstanding Financial and Commercial Results:Strong Y/Y growth: net product sales ↑18%, adjusted diluted EPS ↑21%Successful launches: POMALYST®/IMNOVID® and ABRAXANE® pancreatic cancer

Advancing the Portfolio:Apremilast PSOR US NDA and PsA/PSOR EU submission on-track for year endCHMP opinion for ABRAXANE® pancreatic cancer in Q4

Building for the Future:>25 Pivotal/phase III programs and 12 novel early/mid-stage programs underway>30 pre-clinical programs in developmentAdvanced and entered into new strategic collaborations

5

Our Strategy for Long-Term Growth

Focusing on operational 1 g pexcellence

Capitali ing on strength in

1

Capitalizing on strength in Hematology2 Industry leading

performance and growth

Building new businesses in Oncology and I & I3

and growth

Sustaining innovation and long-term growth4

6

Jackie Fouse

Q3 2013 Financial Highlights

Excellent operating results across the P&L:Year over year net product sales grew 18% and adjusted diluted EPS grew 21%Year-over-year net product sales grew 18% and adjusted diluted EPS grew 21%

Adding value with financial drivers:Total repurchases in Q3 $211M, 1.5M shares; YTD ~$2.05B, 17.8M shares

Strong momentum including:Strong momentum including:REVLIMID® year-over-year growth of 12% EU approval for IMNOVID® in RRMM in AugustU S approval for ABRAXANE® in pancreatic cancer in SeptemberU.S. approval for ABRAXANE® in pancreatic cancer in September

Investing for the future:Executing on investment plan for I&IEntered into several new collaborations

8

Total Net Product Sales

Q3(Growth Rates = Growth vs. Prior Year Period)

$1,388$1,644

$1,218*

on

↑38% ↑14%$ M

illio

↑18%

Q3:11 Q3:12 Q3:13*Q3:11 adjusted

9

Volume Drove Q3:13 Net Product Sales Growth

Contribution to Q3:13 Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)

$1 600

$1,800 ↑18.4%↓1.2%↑19.3% ↑ 0.3%

$1,200

$1,400

$1,600

on

$600

$800

$1,000

$ M

illio

$200

$400

$600

$0Q3:12 Volume Price Fx / Hedge Q3:13

10

Adjusted Diluted Earnings Per Share

Q3(Growth Rates = Growth vs. Prior Year Period)

$1.29

$1.56

$1.02

r sha

re

↑26%↑36% ↑21%

olla

rs p

erD

Q3:11 Q3:12 Q3:13

11

Adjusted Diluted EPS Growth Driven by Operating Income

Contribution to Q3:13 Adjusted Diluted EPS

$1.56$0.02$0.23$1.29 ($0.01) $0.03

r Sha

reol

lars

Per

Do

Q3:12 Operating Income Financial Income / Expense

Tax Rate Share Count Q3:13

12

Worldwide Net Product Sales

Net Product Sales ($ million)Q3

2013∆ vs.Q3:12

∆ vs.Q2:13

REVLIMID® Total $1,090 ↑12% ↑4%

U.S. $633 ↑16% ↑1%

International $457 ↑8% ↑7%International $457 ↑8% ↑7%

VIDAZA® Total $220 0% ↑4%U.S. $77 ↓6% ↓8%

I t ti l $143 ↑4% ↑13%International $143 ↑4% ↑13%

ABRAXANE® Total $170 ↑60% ↑10%

U.S. $132 ↑64% ↑10%

International $38 ↑47% ↑7%

POMALYST®/IMNOVID® Total $90 NA ↑35%

U S $77 NA ↑33%U.S. $77 NA ↑33%

International $13 NA ↑47%

13

Volume Drove Q3:13 REVLIMID®

Net Product Sales Growth

Contribution to Q3:13 REVLIMID® Net Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)

$1,200 ↑12.3%↓1.1%↑11.0% ↑2.4%

$800

$1,000

on

$600

$800

$ M

illio

$200

$400

$0Q3:12 Volume Price Fx / Hedge Q3:13

14

Key P&L Line Items (Adjusted)

Q32013

∆ vs.Q3:12

Through Sep 2013

∆ vs.Through Sep 2012Sep 2012

Product Gross Margins 95.1% ↑20 bps 94.9% ↑20 bps

R&D Expenses% of revenue

$372M22.2% ↓90 bps 22.1% ↓230 bps

SG&A Expenses% of revenue

$405M24.2% ↑150 bps 23.7% ↑110 bps

Operating ProfitOperating Profit Margin 48.9% ↓20 bps 49.3% ↑150 bps

Effective Tax Rate 16.8% ↑30 bps 16.8% ↑30 bps

15

Effective Tax Rate 16.8% ↑30 bps 16.8% ↑30 bps

Adjusted Operating Leverage Increased

37.9%41.0%

44.3% 45.1%48.1% 49.3%

28.0%

25.4% 23.4% 22 8% 22.8% 22 1%24.1%

26.0% 25.5% 25.8%23.8% 23.7%

25.4% 23.4% 22.8% 22.8% 22.1%10.6% 8.0% 7.1% 6.5% 5.4% 5.1%

2008 2009 2010 2011 2012 YTD 2013

Operating Margin SG&A R&D COGS

16

Focused on Returns

25.0%

$

$14.0 ROIC

20.0%$10.0

$12.0

10 0%

15.0%

$6.0

$8.0

Bill

ion

5.0%

10.0%

$2 0

$4.0

$ B

Average Invested Capital

0.0%$0.0

$2.0

2008 2009 2010 2011 2012 2013 (TTM)

Average Invested Capital

Capital Base Net of Cash* Capital Base including Cash* ROIC Net of Cash* ROIC

17

GAAP operating income used for all periods except 2008. Refer to reconciliation tables for ROIC calculation methodology* For purposes of this calculation, cash includes cash and cash equivalents and marketable securities available for sale

Cash and Marketable Securities

($ billion) 9/30/13 12/31/12($ )

Cash and Marketable Securities $5.85 $3.90

• Cash flow from operations was $571.1M during Q3

• In Q3 2013, purchased 1.5M shares for total cost $211M

• YTD, purchased 17.8M shares for total cost ~$2.05B, p

• Issued aggregate of $1.5B in five-, ten- and thirty-year notes

18

2013 Adjusted Guidance Updated

2013 Guidance

∆ vs.2012 Previous

Total Net Product Sales $6.2B+ ↑~15% ~$6.2B

REVLIMID®

N t P d t S lMid-to-upper

d f ↑~13% $4.2-4.3BNet Product Sales end of range ↑ 13% $4.2 4.3B

Adjusted Diluted EPS $5.90-$5.95 ↑~21% $5.80- $5.90

Key Assumptions

• Range includes a generic VIDAZA® entryRange includes a generic VIDAZA entry

• Adjusted Operating Margin of ~49%

• Share count remains constant with YE:12

• Using midpoint of range to calculate growth

• Includes investment to build I&I franchise19

Mark Alles

Q3 Hematology & Oncology Franchise Results

Excellent Progress on Key ObjectivesExcellent Progress on Key Objectives

Product Growth Drivers Intact

Accelerating Franchise Expansion Opportunities

21

Near-term Hematology & Oncology Growth Drivers

• Q3:13 sales $1,090M; 4% Q/Q growth, 12% Y/Y growth• April 2013 EC approval for del 5q MDS • June 2013 FDA approval for MCL• July 2013 positive Phase III MM-020 data in NDMM• MM-020 data at ASH (December 2013)

• Q3:13 sales $90M; 35% Q/Q growthQ3:13 sales $90M; 35% Q/Q growth• February 2013 FDA approval for RRMM• August 2013 EC approval for RRMM• New market approvals throughout 2014

• Q3:13 sales $220M; 4% Q/Q growth, flat Y/Y growth• September 2013 generic entrant• VIDAZA® AML-001 Phase III data by year-end 2013• Enrolling CC-486 Phase III (SPA) studies in MDS and AML

• Q3:13 sales $170M; 10% Q/Q growth, 60% Y/Y growth• September 2013 FDA approval for metastatic pancreatic cancer

22

September 2013 FDA approval for metastatic pancreatic cancer• Expect CHMP opinion for metastatic pancreatic cancer (Q4:13)• Expect final OS data in metastatic melanoma (Q4:13)

ABRAXANE® Melanoma UpdateExpecting Overall Survival Analysis in Q4:13

Progression Free Survival* Overall Survival**Progression Free Survival Overall Survival

* Final PFS presented at November 2012 Society of Melanoma (SMR) Meeting** Interim OS presented at November 2012 SMR Meeting Interim OS presented at November 2012 SMR Meeting

ASH 2013 Submitted AbstractsFeatures Significant Data in Multiple Myeloma, MDS, NHL and CLL

TOPIC LEN POM AZA ROM ACE- ACE- CC- CC- CC- CC- Dx TOTAL011 536 122 223 292 486

MM 54 19 1 1 1 2 78

MDS 16 11 4 31

AML 1 5 1 7

MF 2 2

NHL 17 1 1 2 1 22

CLL 10 2 12

Anemia 4 1 5

Other 2 2 1 5Other 2 2 1 5

TOTAL 100 24 17 2 5 1 1 2 3 1 6 162

ASH 2013 Submitted AbstractsFeatures Significant Data in Multiple Myeloma, MDS, NHL and CLL

TOPIC LEN POM AZA ROM ACE- ACE- CC- CC- CC- CC- Dx TOTAL011 536 122 223 292 486

MM 54 19 1 1 1 2 78

MDS 16 11 4 31

PFS2 in Elderly Patients with Newly Diagnosed Multiple Myeloma (NDMM): Results From the MM-015 Study

AML 1 5 1 7

MF 2 2

NHL 17 1 1 2 1 22

Lenalidomide Maintenance Therapy in Multiple Myeloma: A Meta-analysis of Randomized Trials

I iti l Ph III R lt f th FIRST® (F tli I ti ti fCLL 10 2 12

Anemia 4 1 5

Other 2 2 1 5

Initial Phase III Results of the FIRST® (Frontline Investigation of Revlimid + Dexamethasone versus Standard Thalidomide) Trial

(MM-020/IFM 07 01) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Stem Cell Transplantation (SCT)Other 2 2 1 5

TOTAL 100 24 17 2 5 1 1 2 3 1 6 162

( ) g p ( )

REVLIMID® in NDMM: MM-020 Design and Objectives

Trial ArmsPatients

Trial Arms

N = 1623 N l di d

REVLIMID® / low dose dexamethasone continuous to disease progression

• Newly diagnosed

• Transplant-ineligiblemultiple myeloma REVLIMID® / low dose dexamethasone

18 28-day cyclesR

1:1:1 • Stratified by age

(65-75 vs. > 75 years) and disease stage (ISS I/II vs. III)

y y

THALOMID® / melphalan / prednisone12 42 day cycles12 42-day cycles

• Primary Endpoint: Progression-free survival• Secondary Endpoint: Overall survival

26

Generating Strong Franchise Momentum

OurStrategy

• Capitalize on our strength in Hematology• Build our global Oncology franchise

OurP f

• Focused on operational excellence2013 l t d t d $6 2BPerformance • 2013 sales expected to exceed $6.2B

OurOutlook

• Long growth runway with multiple drivers• Accelerating the pace of scientific innovation

27

Scott Smith

Building I&I Through Executing Successful Business Strategy

Target Target significant markets with high unmet1 Target Markets

Target significant markets with high unmet medical need1

Clinical Development

Conduct leading edge clinical development programs2

Launch Capabilities Build world class global launch capabilities3

Accelerate Portfolio

Accelerate I&I portfolio by developing pipeline through internal and external opportunities

4

29

Rapid Succession of Approvals Expected Through 2014 in Core Markets & Beyond

S b it

On Track

S b it I l t

Submit Australia and Switzerland PSOR/PsA

S b it

Submit EU MAA AS

PDUFA DateMarch 21

Submit EU Approval

Submit Canada

PSOR NDS

Approval Approval Approval

Implement next tier

registrations

Submit US AS NDA

Submit CanadaAS NDS

Approval US AS

March 21, 2014

Submit US PsA NDA

Submit EU PsA/PSOR

MAA

Submit USPSOR NDA

Approval US PsA

Approval US PSOR

Submit Canada

PsA NDS

Approval Canada

PsA

Approval CanadaPSOR

ApprovalEU

PsA/PSOR

Q1Q1 Q2Q2 H1H1 H2H2 H1H1H2H2

2013 2014 20152013 2014 2015

30

• Exploring opportunities to file Behçet’s

Important Apremilast Psoriasis Phase III data at EADV

DLQISCALPNail

-2.1-3-2-10

in D

LQI

line

6.5

-10

0

10

ge F

rom

Sc

ore

46.5

40

50

ng

(%)

*

DLQISCALPNail

2.1

-6.6-8-7-6-5-4-3

*

Mea

n C

hang

e i

From

Bas

el

-22.5

-40

-30

-20

-10

*

an P

erce

nt C

hang

Bas

elin

e, N

APS

I S

17.5

10

20

30

Patie

nts

Ach

ievi

nSc

PGA

Res

pons

e

*P<0 0001 vs placebo based on ANCOVA

Week 16 (LOCF)*

Apremilast 30 mg BIDPlacebo

-50Mea B

*P<0 0001 vs placebo based on ANCOVA


Week 16 (LOCF) 0

. *P<0.0001 vs. placebo, based on the chi square test Week 16 (LOCF):


Week 16 (LOCF)

P<0.0001 vs. placebo, based on ANCOVA model. Baseline mean DLQI: placebo, 12.1; apremilast 30 mg BID, 12.7. Week 16 (LOCF): placebo n=274, apremilast 30 mg BID n=556.

*P<0.0001 vs. placebo, based on ANCOVA model. Week 16 (LOCF): placebo, n=178; apremilast 30 mg BID, n=339.

chi-square test. Week 16 (LOCF): placebo, n=189; apremilast 30 mg BID, n=374.

LOCF=last observation carried forward.

31

Source: Papp et al EADV 2013, Reich et al EADV 2013

ACR 2013: Apremilast PsA 52-Week Results, Plenary and Late Breaking Presentation

PALACE Program (1 3)PALACE Program (1-3) • PALACE 2 52-Week Results (Oral)• PALACE 3 52-Week Update• Pooled Safety• Pooled Enthesitis/Dactylitis (Oral)• Pooled Laboratory Data• Pooled HAQ-DI• Pooled TJC and SJC

BCT -001 (Oral Plenary) PALACE 4 DMARD Naïve 52-week results (Late Breaker)

CC-220

32

I&I Has Transformational Potential for Patients and for Celgene

Apremilast

• Emerging 52-week data enhancing the profile of apremilast and supports significant

Potential to createa cornerstone

for treatment of

p p pp gopportunity across multiple segments of the market

• Submissions progressing on schedule for treatment ofpsoriatic disease as well

as other serious immunologic

diseases

p g g

• Preparations for Q1:14 launch ongoing

• Commercial build-out on track, hiring talented e perienced leadership in Sales diseasestalented, experienced leadership in Sales, Marketing and Medical Affairs

• ACR will be a significant meeting in advance of the US PsA launchof the US PsA launch

33

Bob Hugin

Key Near-Term Milestones

Product Milestone Expected Timing

Phase III MM-020 data in NDMM Q2:13 / Q3:13

US decision for mantle cell lymphoma Q2:13

• Resubmission of the NDMM application in EU H2:13 → Q1:14

• Submit for approval in the US in NDMM H2:13 → Q1:14

• Approvals and reimbursement for RRMM in emerging markets Throughout 2013

US Regulatory decision for RRMM Q1:13

EU Regulatory decision for RRMM Q3:13

×× Phase III myelofibrosis data H1:13

Submit regulatory applications for pancreatic cancer in US & EU H1:13

• Final phase III overall survival data in melanoma H2:13

FDA decision for pancreatic cancer Q3:13FDA decision for pancreatic cancer Q3:13

Phase III ESTEEM data in psoriasis Q1:13

• Submit for approval in psoriatic arthritis and psoriasis US; ROW Throughout 2013

Ph III d t i t t t ï i ti th iti H1 13Phase III data in treatment-naïve psoriatic arthritis H1:13

Complete enrollment in Phase III ankylosing spondylitis trial H2:13

35

Q3 2013 Conference CallOctober 24, 2013

Reconciliation Tables


2012

7.43,9

70.1

$

0.6

89.2

8.04,0

59.3

7.6219

.0

5.0

1,250

.7

5.81,0

03.4

7.1

132.1

9.428

.9

4.9

2,634

.1

3.11,4

25.2

4.9)

(34.0)

8.21,3

91.2

2.7198

.1

5.51,1

93.1

$

982.7

5$

87

2.69

$

4.7434

.1

0.5

443.4

nth Pe

riods

Ended

ptemb

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12201

3

1,388.

04,6

37$

31.2

100

1,419.

24,7

38

74.6

247

441.5

1,4

95

354.6

1,2

35

46.2

197

0.7

79

917.6

3,2

54

501.6

1,4

8 3

(25.1)

(3 4

476.5

1,4

4 8

52.3

21 2

424.2

1,2

3 5$

0.99

2.9

$

0.97

2.8

$

427.2

41 4

436.3

430

mber

31,12 3,9

00.3

1,734.

3308

.5 2,7

71.3

5,694.

5

s ncom

e

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Nine-M

on Sep

2013

20

1,644.

0$

1$

30.4

1,6

74.4

1

86.2

584

.5

448.7

65.

7

33.7

1,2

18.8

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(13.6)

442.0

69.5

372.5

$

$

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$

$

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7$

$

412.3

428

.8

Septe

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30,De

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2013

20

5,847.

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13,629

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405.9

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5.51,1

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0.575.

8

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39

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Explanation of adjustments:(1) Exclude the net (benefit) cost of activities arising from the acquisition of Pharmion Corp. (Pharmion) that are planned to be exited.(2) Exclude share-based compensation expense totaling $92.0 for the three-month period ended September 30, 2013 and $62.5 for the

three-month period ended September 30, 2012. Exclude share-based compensation expense totaling $227.4 for the nine-month periodended September 30 2013 and $170 9 for the nine-month period ended September 30 2012 ended September 30, 2013 and $170.9 for the nine month period ended September 30, 2012.

(3) Exclude in-process research and development impairments recorded as a result of changes in estimated probability-weighted cash flows.(4) Exclude upfront payments for research and development collaboration arrangements.(5) Exclude amortization of intangible assets acquired in the acquisitions of Pharmion, Gloucester Pharmaceuticals, Inc. (Gloucester),

Abraxis BioScience Inc. (Abraxis) and Celgene Avilomics Research, Inc. (formerly known as Avila Therapeutics)(Avila).(6) Exclude acquisition related charges and restructuring, including changes in the fair value of contingent consideration, related to the

acquisitions of Gloucester, Abraxis and Avila.(7) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating( ) j j p p g

tax adjustments, including one-time effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits and deferred taxes on unremitted foreign earnings.

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Return on Invested Capital Calculation

Return on Invested Capital (ROIC)2013 (TTM) 2012 2011 2010 2009 2008

Operating income 1,804,348 1,746,442 1,442,753 989,635 841,526 (1,464,218) Certain charges (1) 2,043,069

Operating income (non-GAAP for 2008) 1,804,348 1,746,442 1,442,753 989,635 841,526 578,851

Effective tax rate 14% 13% 7% 13% 20% 24%Effective tax rate 14% 13% 7% 13% 20% 24%Operating income after tax (non-GAAP for 2008) 1,555,374 1,512,428 1,339,017 860,221 669,930 439,272

Total equity 5,894,666 5,694,467 5,512,727 5,995,472 4,394,606 3,491,328 Certain charges (1) 1,979,510 1,979,510 1,979,510 1,979,510 1,979,510 1,979,510 Total debt 4,634,212 3,079,792 1,802,269 1,247,584 - -

Total capital 12,508,388 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838

Total capital beginning of period 10,802,428 9,294,506 9,222,566 6,374,116 5,470,838 3,040,499 p g g pTotal capital end of period 12,508,388 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838

Average total capital 11,655,408 10,024,138 9,258,536 7,798,341 5,922,477 4,255,669

ROIC 13.3% 15.1% 14.5% 11.0% 11.31% 10.3%

Return on Invested Capital (ROIC), Net of Cash2013 (TTM) 2012 2011 2010 2009 2008

Operating income 1,804,348 1,746,442 1,442,753 989,635 841,526 (1,464,218) Certain charges (1) 2,043,069

Operating income (non-GAAP for 2008) 1,804,348 1,746,442 1,442,753 989,635 841,526 578,851

Effective tax rate 14% 13% 7% 13% 20% 24%Operating income after tax (non-GAAP for 2008) 1,555,374 1,512,428 1,339,017 860,221 669,930 439,272

Total equity 5,894,666 5,694,467 5,512,727 5,995,472 4,394,606 3,491,328 Certain charges (1) 1,979,510 1,979,510 1,979,510 1,979,510 1,979,510 1,979,510 Total debt 4,634,212 3,079,792 1,802,269 1,247,584 - - Less Cash and Marketable Securities (5,847,300) (3,900,270) (2,648,154) (2,601,301) (2,996,752) (2,222,091)

Total capital 6,661,088 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747

Total capital beginning of period 6,969,492 6,646,352 6,621,265 3,377,364 3,248,747 3,040,499 Total capital end of period 6,661,088 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747

Average total capital 6,815,290 6,749,926 6,633,809 4,999,315 3,313,056 3,144,623

ROIC N t f C h 22 8% 22 4% 20 2% 17 2% 20 2% 14 0%

42

ROIC, Net of Cash 22.8% 22.4% 20.2% 17.2% 20.2% 14.0%

(1) Excludes $1.7 billion of IPR&D expense in 2008 associated with the acquisition of Pharmion, as well as $300 millionof expense related to the acquisition of intellectual property rights for Vidaza in 2008 prior to it's launch. Amounts adjustedfor tax effects in 2008 are excluded from equity in all years including and subsequent to 2008.

Appendix

Celgene Pipeline

44

Celgene Pipeline

45

Celgene Pipeline

46

REVLIMID® Multiple Myeloma Late Stage Programs

Patient Population NDMM Non-ASCT Eligible NDMM Non-ASCT Eligible

Trial Name MM-015MM-020FIRST®

Phase III III

Target Enrollment 459 1,623

D i

Arm A: REVLIMID® (10mg) / melphalan / prednisone for 9 cycles followed by

REVLIMID® (10mg) maintenance to disease progression

Arm B: : REVLIMID® (10mg) / melphalan /

Arm A: REVLIMID® (25mg)/ low-dose dexamethasone until disease progression

Arm B: REVLIMID® (25mg)/ low-dose dexamethasone for 18 4-week cycles (72Design Arm B: : REVLIMID (10mg) / melphalan /

prednisone for 9 cycles followed by placebo maintenance to disease progression

Arm C: Melphalan / prednisone for 9 cycles followed by placebo maintenance to disease

progression

dexamethasone for 18 4 week cycles (72 weeks)

Arm C: THALOMID® / melphalan / prednisone for 12 6-week cycles (72

weeks)

Primary Endpoint Progression Free Survival Progression Free Survival

Study met primary endpoint July 2009Data presented at ASH 2009 with follow-up d t t ASCO 2010 ASH d IMW 2011

Enrollment completeStatus data at ASCO 2010, ASH and IMW 2011,

ASH 2012 and IMW 2013. Published in NEJM May 2012

Follow-up continuing

Trial met primary endpoint for PFSData presentation at ASH 2013

47

REVLIMID® Multiple Myeloma Late Stage Programs

Patient Population Maintenance Post-ASCT Maintenance Post-ASCT

Trial Name CALGB 100104 IFM 2005-02Trial Name CALGB 100104 IFM 2005-02

Phase III III

Target Enrollment 459 614

Arm A: REVLIMID® (10mg) until disease Arm A: REVLIMID® consolidation (25mg) for 2 cycles followed by REVLIMID® (10-

15mg) until disease progressionDesign progression

Arm B: Placebo until disease progression

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

for 2 cycles followed by placebo until disease progression

P i E d i t Ti t P i P i F S i lPrimary Endpoint Time to Progression Progression Free Survival

Status

Trial met primary endpoint in Dec 2009Data presented at ASCO 2010. Follow-up data at ASH 2010, IMW 2011 and IMW

2013

Trial met primary endpoint in June 2010Data presented at ASCO 2010. Follow-up data at ASH 2010 and IMW 2011.Status 2013.

Published in NEJM May 2012.Follow-up for survival continuing

pPublished in NEJM May 2012.

Follow-up for survival continuing

48

POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs

Patient Population RRMM

Trial NameMM-007

Trial NameOPTIMISMM

Phase III

Target Enrollment 782

Arm A: POMALYST®/IMNOVID® (4mg),

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

Primary EndpointProgression Free Survival

Status Trial enrolling

49

MDS/AML/MF Late Stage Programs

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

Low risk/INT-1 transfusion-dependent MDS

CC-486Molecule REVLIMID® (Oral Azacitidine)

Trial Name MDS-005 AZA-MDS-003

Phase III III


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 formore than 12 weeks

Status Enrollment complete Trial enrolling

50


Patient Population Elderly Newly Diagnosed AML Post induction AML Maintenance

MoleculeVIDAZA®

(azacitidine)CC-486

(oral azacitidine)(azacitidine) (oral azacitidine)

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

Phase III III

Target Enrollment 488 460Target Enrollment 488 460

Arm A: VIDAZA®

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

A A CC 486 (150 200 )Design 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

StatusEnrollment complete

Trial enrollingStatusTop-line data YE2013(E)

Trial enrolling

51


Patient PopulationMyeloproliferative-

Neoplasm-Associated Myelofibrosis

Molecule POMALYST®/IMNOVID®Molecule POMALYST®/IMNOVID®

Trial Name RESUME (MF-002)

Phase III


DesignArm A: POMALYST®/IMNOVID®

(0.5mg) dailyArm B: Placebo

Primary Endpoint Proportion of subjects achieving RBC-transfusion-independence

Trial did not meet primary endpointStatus

p y pData to be submitted to a future

medical congress

52

REVLIMID® Chronic Lymphocytic Leukemia Late Stage Programs

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

Trial NameCLL-008ORIGIN®

CLL-002CONTINUUM®

Phase III III

Target Enrollment 450 400Target Enrollment 450 400

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

2 5mg/day escalated to 10mg/day) untilDesign disease progression – 28-day cycle

Arm B: Chlorambucil (0.8 mg/kg) D1-15 for ~13 cycles (12 months) of 28-day cycle

2.5mg/day escalated to 10mg/day) until disease progression - 28-day cycle

Arm B: Placebo

Primary Endpoint Progression Free Survival Overall Survival and Progression Free Survival

St t

Enrollment completed in Q1:13Trial put on clinical hold & discontinued in

J l 2013Trial enrolling

Status July 2013Data to be presented at a future medical

congress

gEnrollment to complete in H2:14(E)

53

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) D2 22 for p to 18 28 da c cles and

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-bendamustinebendamustine

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

54

StatusTrial enrolling

Enrollment to complete in Q4:13(E)Trial enrolling

Enrollment to complete in H2:14(E)


Patient Population Relapsed or Refractory Follicular Lymphoma

Trial NameMAGNIFYNHL-007

Phase III

Target Enrollment 500Target Enrollment 500

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 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

Primary Endpoint Progression Free Survival

Status Trial enrolling

55


Patient Population Relapsed or Refractory Indolent Lymphoma

Trial NameAUGMENTNHL-008

Phase III

Target Enrollment 500Target Enrollment 500

Design

Arm A: REVLIMID® (10-20mg) D1-21 / Rituximab 375 mg/m2 weekly for cycle 1 then D 1 of cycles 3, 5, 7,9 and 11 for 12 28-day cycles followed by REVLIMID®

(10mg) D1-21 / Rituximab 375 mg/m2 D 1 of cycles 13, 15, 17,19, 21, 23, 25, 27 and 29 for 18 28-day cycles followed by REVLIMID® (10mg) D 1-21 until disease

progression – 28 day cycleDesign progression 28 day cycleArm 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


Status Trial enrolling soon

56

ABRAXANE® Solid Tumor Late Stage Programs

Patient Population Metastatic Malignant Melanoma Metastatic Adenocarcinoma of the Pancreas

Trial Name CA033MPACTCA046CA046

Phase III III


Arm A: ABRAXANE® (150 mg/m2) D 1, 8, Arm A: ABRAXANE® (125 mg/m2) and gemcitabine (1000 mg/m2) weekly for 3

weeks of a 4 week cycleDesign

( g )and 15 - 28-day cycle

Arm B: Dacarbazine (1000 mg/m2) D 1 -21-day cycle

weeks of a 4 week cycleArm B: Gemcitabine (1000 mg/m2)

weekly for 7 weeks of an 8 week cycle(Cycle 1); Weekly for 3 weeks of a 4

week cycles (Cycle 2+)

Primary Endpoint Progression Free Survival Overall Survival

Primary endpoint met Efficacy/safety data presented at Society

Primary endpoint metEfficacy/safety data presented at ASCO

57

StatusEfficacy/safety data presented at Society

of MelanomaResearch Meeting in November 2012Final OS data expected by YE2013(E)

GI in January 2013US approval in Sept 2013CHMP opinion in Q4:13(E)


Patient Population First-Line Triple Negative Metastatic Breast Cancer

Adjuvant Therapy in Surgically Resected Pancreatic Cancer

Trial NametnAcity™

ABI-007-MBC-001PANC-003

ABI 007 MBC 001

Phase II/III III

Target Enrollment 240/550 800

D i

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 A: ABRAXANE® (125 mg/m2) /

Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28 d lDesign Arm 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

6 28-day cyclesArm B: Gemcitabine (1000 mg/m2) D 1, 8

and 15 for 6 28-day cycles.

IV, D 1 and 8 – 21-day cycle

Primary Endpoint Progression Free Survival Disease Free Survival

58

Status Trial Enrolling Trial Enrolling Soon


Patient PopulationMaintenance After Induction in

Squamous Non-Small Cell Lung Cancer

Trial Name NSCL 003Trial Name NSCL-003

Phase III


Design

Induction: ABRAXANE® (100 mg/m2) D 1, 8,and 15 / Carboplatin (6 mg min/mL) D 1 for 4

21-day cyclesMaintenance: Design

Arm A: ABRAXANE® (100 mg/m2) D 1 and 8 plus BSC until disease progression – 21-day

cycleArm B: BSC until disease progression


Status Trial Enrolling soon

59

Status Trial Enrolling soon

I&I Late Stage Programs

Patient Population

Moderate-to-SevereLate Stage Psoriatic

ArthritisModerate-to-Severe Late Stage Psoriatic Arthritis

Moderate-to-Severe Late Stage Psoriatic Arthritis

with Skin Lesions

M l l A il t A il t A il tMolecule Apremilast Apremilast Apremilast

Trial NamePALACE-1PSA-002

PALACE-2PSA-003

PALACE-3PSA-004

Phase III III III

Target Enrollment 495 495 495

Design

Arm A: Apremilast (20mg)twice daily

Arm B: Apremilast (30mg) twice daily

Arm C: Placebo



Arm C: Placebo


Arm B: Apremilast (30mg)twice daily

Arm C: Placebo

Primary Endpoint ACR20 ACR20 ACR20

Enrollment complete Enrollment completeT li d t i S t 2012

Enrollment completeStatus Efficacy/safety data

presented at ACR 2012, EULAR 2013 and ACR 2013

Top-line data in Sept 2012Long-term efficacy/safety to be presented at ACR 2013

pLong-term efficacy/safety to be

presented at ACR 2013

60


Patient Population

Treatment Naïve Moderate-to-SevereLate Stage Psoriatic

Arthritis

Moderate-to-SeverePlaque Psoriasis

Moderate-to-Severe Plaque Psoriasis

Molecule Apremilast Apremilast Apremilast

Trial NamePALACE-4PSA-005

ESTEEM-1PSOR-008

ESTEEM-2PSOR-009

Phase III III III

Target Enrollment 495 825 825

Design



A C Pl b

Arm A: Apremilast (30mg) twice daily

Arm B: Placebo


Arm B: PlaceboArm C: Placebo

Primary Endpoint ACR20 PASI75 PASI75

Enrollment complete Enrollment complete Enrollment completeStatus

Enrollment completeEfficacy/safety to be

presented in ACR 2013

Enrollment completeEfficacy/safety data presented at AAD 2013 and EADV 2013

Enrollment completeEfficacy/safety data to be

presented in 2014(E)

61


Patient Population Moderate-to-Severe Plaque Psoriasis Ankylosing Spondylitis

Molecule Apremilast ApremilastMolecule Apremilast Apremilast

Trial Name PSOR-010POSTURE

AS-001

Ph IIIb IIIPhase IIIb III


Design

Arm A: Apremilast (30 mg) twice dailyArm B: Etanercept (50 mg subcutaneous)

once weeklyArm C: Placebo

Arm A: Apremilast (20mg) twice dailyArm B: Apremilast (30mg) twice daily

Arm C: Placebo

Primary Endpoint PASI75 ASAS20

Trial enrollingStatus

Trial enrollingExpected to complete in H1:14(E)

Trial enrollingEnrollment complete

Top line data expected in H1:14(E)

62

q3 2013 conference call€¦ · 2013 ∆ vs. q3:12 through sep 2013 ∆ vs. through sep 2012sep...

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