60
Q4 and Full-Year 2014 Conference Call J 29 2015 January 29, 2015
Q4 and Full-Year 2014 Conference Call
J 29 2015January 29, 2015
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
2
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.
Attendees
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
3
Q&A
Bob Hugin
Full-Year 2014: Exceptional Financial and Operating Performance
Strong top and bottom line growth
Outstanding Financial ResultsOutstanding Financial Results– Strong top- and bottom-line growth – Continued operating momentum with improving adjusted margins
– Growth across product lines driven by increased market share and duration– Launch of OTEZLA®
Strong Performance Across All Operating MetricsStrong Performance Across All Operating Metrics
Launch of OTEZLA
Building for the FutureBuilding for the Future
– REVLIMID® NDMM expected regulatory decisions in U.S. and EU– Advancing key early- to mid-stage pipeline programs
gg
5
Peter Kellogg
Full-Year 2014 Financial Highlights
Year-over-year product sales grew 19% and adjusted diluted EPS grew 24%Adj t d ti i i d b 220 b i i l id f 160 b
Outstanding Operating ResultsOutstanding Operating Results
Adjusted operating margins improved by 220 bps vs. original guidance of 160 bps
Excellent Performance on Operating MetricsExcellent Performance on Operating Metrics
Strong product growth from REVLIMID®, POMALYST®/IMNOVID® and ABRAXANE®
OTEZLA® launch accelerating
~$2.9B in shares repurchased in FY2014; ~$0.5B in shares repurchased in Q4:14 Adjusted effective tax rate improved by 80 bps due to favorable geographic mix
Adding Value with Financial DriversAdding Value with Financial Drivers
j p y p g g p
Ad d i t l/ h III t i l d l t d l t id t i li
Investing for the FutureInvesting for the Future
7
Advanced pivotal/phase III trials and accelerated early- to mid-stage pipeline Entered into new collaborations and expanded existing partnerships
Total Product Sales(Growth Rates = Growth vs. Prior Year Period)
$7,564Q4 Full Year
$2,055 $5,386
$6,362
$1,416
$1,725
Mill
ions
↑14% ↑22% ↑15% ↑18%↑19% ↑19%
Q4:12 Q4:13 Q4:14 2012 2013 2014
8
Worldwide Net Product Sales
Net Product Sales(in $ Millions) Q4:14 ∆ vs.
Q4:13 FY2014 ∆ vs.FY2013( )
REVLIMID® Total $1,322 ↑16% $4,980 ↑16%U.S. $797 ↑20% $2,916 ↑17%International $525 ↑11% $2,064 ↑15%
VIDAZA® Total $154 ↓8% $612 ↓24%VIDAZA® Total $154 ↓8% $612 ↓24%U.S. $9 ↓67% $43 ↓84%International $145 ↑3% $569 ↑8%
ABRAXANE® Total $236 ↑17% $848 ↑31%$ $U.S. $172 ↑8% $624 ↑24%
International $64 ↑50% $224 ↑55%POMALYST®/IMNOVID® Total* $202 ↑67% $680 ↑123%
U.S. $132 ↑47% $443 ↑80%International $70 ↑122% $237 ↑298%
OTEZLA® (U.S.) $47 NA $70 NAOther Total $93 ↓5% $374 ↑15%
U S $75 ↓4% $299 ↑24%U.S. $75 ↓4% $299 ↑24%International $18 ↓10% $75 ↓10%
9
Footnote: * IMNOVID® was approved in the EU on Aug 5, 2013
Volume Drove Q4:14 Growth
Contribution to Q4:14 Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
$2 000
↑19.1%↓1.4%↑17.4% ↑3.1%
$1,500
$2,000
lions
$1,000
Mill
$0
$500
$0Q4:13 Volume Price Fx / Hedge Q4:14
10
Volume Drove Full-Year 2014 Growth
Contribution to FY2014 Product Sales Growth(Growth Rates = Growth vs. Prior Year Period)
$8,000 ↑18.9%↓0.2%↑15.7% ↑3.4%
$5 000
$6,000
$7,000
lions
$3,000
$4,000
$5,000
Mill
$0
$1,000
$2,000
$02013 Volume Price Fx / Hedge 2014
11
Adjusted Diluted Earnings Per Share(Growth Rate = Growth vs. Prior Year Period)
$3.71
Q4 Full Year
$1.01$2.98
e
$
$0.66$0.76 $2.45
s Pe
r Sha
re
↑26% ↑14% ↑30% ↑21%
Dol
lars
↑33% ↑24%
Q4:12 Q4:13 Q4:14 2012 2013 2014
12
Footnote: Adjusted EPS is split-adjusted for all periods presented
Key P&L Line Items (Adjusted)
Q4:14 ∆ vs.Q4:13 FY2014 ∆ vs.
FY2013Q4:13 FY2013
Product Gross Margin 95.3% ↑30bps 95.2% ↑30 bps
R&D $478M $1 651MR&D expenses% of revenue
$478M 22.9% ↓330 bps $1,651M
21.5% ↓170 bps
SG&A expenses% f
$479M ↑20bps $1,778M ↓20 bps% of revenue 23.0% ↑20bps 23.2% ↓20 bps
Operating Margin 49.6% ↑350bps 50.6% ↑220 bps
Effective Tax Rate 15.3% ↓150 bps 16.0% ↓80 bps
13
Q4:14 Adjusted Diluted EPS Growth Driven by Increased Operating Income
Contribution to Q4:14 Adjusted Diluted EPS
$1.01($0.01)$0.21$0.76 $0.02 $0.03
Shar
eD
olla
rs P
er
D
Q4:13 Operating Income
Financial Income / Expense
Tax Rate Share Count
Q4:14
14
Full-Year 2014 Adjusted Diluted EPS Growth Driven by Increased Operating Income
Contribution to FY2014 Adjusted Diluted EPS
$3.71($0.12)$0.71$2.98 $0.03 $0.11
Shar
eD
olla
rs P
er
D
2013 Operating Income
Financial Income / Expense
Tax Rate Share Count
2014
15
Cash and Marketable Securities
(in Billions) 12/31/14 12/31/13
Cash and Marketable Securities $7.55 $5.69
• Cash flow from operations was $2.8B during FY2014• In FY2014 purchased ~$2 9B of shares• In FY2014, purchased ~$2.9B of shares
– In Q4:14, purchased ~$0.5B of shares– ~$3.1B remaining under existing stock repurchase program
I FY2014 i d t f $2 5B i fi t d• In FY2014, issued an aggregate of $2.5B in five-, ten- and thirty-year bonds
16
Focused on Returns
ROIC
30.0%
35.0%
$12 0
$14.0
$16.0
20.0%
25.0%
$8.0
$10.0
$12.0
ion
5 0%
10.0%
15.0%
$4.0
$6.0
$ B
illi
0.0%
5.0%
$0.0
$2.0
2008 2009 2010 2011 2012 2013 2014
Average Invested Capital
Capital Base Excluding Cash* Capital Base* ROIC Excluding Cash* ROIC
17
Footnote: 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
Full-Year 2015 Financial Outlook
FY2015 Guidance
∆ vs.FY2014Guidance FY2014
Total Net Product Sales $9.0B-$9.5B ↑ ~22.3%1
REVLIMID® Net Product Sales $5.6B-$5.7B ↑ ~13.5%1↑
ABRAXANE® Net Product Sales $1.0B-$1.25B ↑ ~32.6%1
Operating Margin2 ~52% ↑140 bps
Effective Tax Rate2 ~16% 0 bps
Diluted EPS2 $4.60-$4.75 ↑ ~26.0%1
Weighted Average Diluted Shares 830M ↓6M
Footnote: 1) Using midpoint of range; 2) Adjusted
18
Strong Sales and Earnings Profile
Product Sales($B)
EPS1
($)
23%CAGR
>$20>$12.50
18%CAGR CAGR
$13-$14 ~$7.50
CAGR
$7.6 $3.71
2014 2017E 2020E 2014 2017E 2020E
19
Footnote: 1) Adjusted
Jackie Fouse
Q4 and Full-Year 2014Hematology & Oncology Franchise Results
– Q4:14 net sales growth of 16% Y/Y and 3% Q/Q; FY net sales growth of 18% Y/YStrong Product Sales and Franchise Operating MomentumStrong Product Sales and Franchise Operating Momentum
g ; g– Multiple brands contributing to growth– REVLIMID® increased globally in both share and duration
Accelerating Product Growth DriversAccelerating Product Growth Drivers– Multiple regulatory submissions, including REVLIMID® NDMM in U.S. & EU– Additional POMALYST®/IMNOVID® data in patients with renal insufficiency and
combination data
Accelerating Product Growth DriversAccelerating Product Growth Drivers
combination data– ABRAXANE® pancreatic approval in Japan and additional reimbursement in key EU
markets
– Completed enrollment in RELEVANCE® and REMARC lymphoma trials– Established proof-of-concept data from mid-stage pipeline
Advancing Franchise Expansion OpportunitiesAdvancing Franchise Expansion Opportunities
21
– Continuing to advance multiple immuno-oncology collaborations
Q4 and Full-Year 2014 REVLIMID® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q4:14 sales $1,322M; +2% Q/Q, +16% Y/Y
Sales ($M)
$1 214$1,300 $1,322
, ; ,• FY2014 sales $4.98B; +16% Y/Y• Increased duration and strong overall and
RRMM market shares $502
$498 $540 $525
$1,144$1,214
• Expansion into NDMM– U.S. and EU regulatory decisions expected in
Q1:15; Japan decision by YE2015• Other New Indications & Opportunities:
®
$502
– REVLIMID® triplet combinations– Ph III trials underway with REVLIMID® in FL
and DLBCL with data possibly expected in late 2016/early 2017
– Updated MM-020 survival data and “FLASH”$642 $716 $760 $797
– Updated MM-020 survival data and FLASH meta-analysis in FL expected at ASCO 2015
– Geographic expansion in RRMM in Russia, Mexico, Brazil and other markets
Q1:14 Q2:14 Q3:14 Q4:14
22
US ROW
Q4 and Full-Year 2014POMALYST®/IMNOVID® Sales Summary
$202
Sales ($M)Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q4:14 sales $202M; ↑12% Q/Q, ↑67% Y/Y
$70 $161$181
$202• FY2014 sales $680M; +123% Y/Y
• Successful global launch of POMALYST®/IMNOVID® continues
$47 $57
$63 $136– Global demand continues to grow in market share and duration
– U.S. POMALYST® leading 3rd line+ share– EU IMNOVID® achieving rapid penetration of
$89 $104 $118 $132
g p p3rd line+ market
– POMALYST® decision in Japan for RRMM expected in H1:15
• Favorable data in patients with renal
Q1:14 Q2:14 Q3:14 Q4:14
• Favorable data in patients with renal insufficiency presented at ASH 2014
• Advancing POMALYST®/IMNOVID®
combinations with other novel agents
23
US ROW
Q4 and Full-Year 2014 ABRAXANE® Sales Summary
$215$212
$236Sales ($M)Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q4:14 sales $236M; ↑11% Q/Q; ↑ 17% Y/Y
$43
$55 $61
$64 $185
$212• FY2014 sales $848M; +31% Y/Y• Establishing a new standard of care
in pancreatic cancer– Market leader in U.S. metastatic 1st line $43 Market leader in U.S. metastatic 1 line– Significant progress in EU pancreatic launch – Patient enrolment into Ph III adjuvant and Ph II
locally advanced trials advancing rapidly
• Expanding in NSCLC
$142 $160 $151
$172• Expanding in NSCLC
EU NSCLC decision expected in Q1:15– Continued enrollment in broad clinical program
in NSCLC
Q1:14 Q2:14 Q3:14 Q4:14
• New Opportunities in breast cancer Favorable Ph III GeparSepto data in
neoadjuvant BC supports value proposition Complete enrollment in Ph II tnAcity™ trial in
24
US ROWmetastatic TNBC
• Anti-PD-1/PDL-1 combo trials initiated
Full-Year 2015 Hematology & Oncology Franchise Outlook
REVLIMID® global net sales in range of $5.6B - $5.7B; +13.5% Y/Y* ABRAXANE® global net sales in the range of $1 0B-$1 25B +32 6% Y/Y*
Growth from Key Products
ABRAXANE global net sales in the range of $1.0B $1.25B, +32.6% Y/Y
REVLIMID® NDMM decisions in U.S., EU and Japan
Expecting Key Regulatory Decisions
REVLIMID® RR MCL in EU POMALYST® RRMM in Japan ABRAXANE® NSCLC in EU
VIDAZA® ld l AML i EU VIDAZA® elderly AML in EU
Launching REVLIMID® in NDMM in U.S. and EULaunching REVLIMID® in NDMM in U.S. and EU
Continuing Successful Launches of POMALYST®/IMNOVID® in RRMM and ABRAXANE® in Pancreatic CancerContinuing Successful Launches of POMALYST®/IMNOVID® in RRMM and ABRAXANE® in Pancreatic CancerAdvancing REVLIMID® Lymphomas Programs in FL and DLBCL Advancing REVLIMID® Lymphomas Programs in FL and DLBCL
25
Initiating Pivotal Programs for AG-221 in AML and Sotatercept/ Luspatercept in beta-Thalassemia and MDSInitiating Pivotal Programs for AG-221 in AML and Sotatercept/ Luspatercept in beta-Thalassemia and MDS
Footnote: * Growth calculated using the mid-point of the range
Scott Smith
Q4 and Full-Year 2014 I&I Franchise Results
Prescription trends continue to accelerate
Executing “Best in Class” U.S. Launch for OTEZLA®Executing “Best in Class” U.S. Launch for OTEZLA®
– Prescription trends continue to accelerate– Rapid dermatologist adoption post psoriasis approval
– Broad label in positive CHMP opinion; Ahead of schedule– Preparations for Q1:15 launch
EU Approval for OTEZLA® in Both PsA and PsoriasisEU Approval for OTEZLA® in Both PsA and Psoriasis
Preparations for Q1:15 launch
Advancing Development of I&I PipelineAdvancing Development of I&I Pipeline– Expanding lifecycle applications for OTEZLA®
– Executing pivotal program for GED-0301– Developing new products – sotatercept and CC-220
g p & pg p & p
27
OTEZLA®’s U.S. Launch Performance Exceeds Analogues
3,000Q2:14 Q3:14 Q4:14
2,000
2,500
x Psoriasis
1,000
1,500
Wee
kly
TRx Approval
0
500
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 391 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39
Week Since Product Launch
OTEZLA (PsA/PSOR) XELJANZ (RA) CIMZIA (Crohn's) SIMPONI (RA/PsA/AS) STELARA (PsO)
Footnote: all products launch aligned based on 4 week trailing average; TRx reflects total number of new and refill prescriptions to-date; OTEZLA® TRx normalized for year-end holidaysSource: IMS SMART data; through week ending December 26, 2014
28
U.S. Psoriasis Launch off to a Strong Start
Number of OTEZLA® Dermatology Prescribers Drivers of Dermatology UptakeDrivers of Dermatology Uptake• Strong initial prescription
demand
• Rapid adoption by2 000
2,500
Psoriasis
Rapid adoption by dermatologists, especially among target prescribers (>50% of decile 7-10) 1,500
2,000
PsoriasisApproval
• Broad utilization across dermatologists; includes biologic-, oral systemic- and t i l it
500
1,000
topical-writers
• Positive initial experience; trialists rapidly converting to
0Apr May Jun Jul Aug Sep Oct Nov Dec
Footnote: Symphony data is subject to restatement; Source: Symphony Prescriber; data through December 26, 2014
29
repeat prescribers
Q4 and Full-Year 2014 OTEZLA® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q4:14 sales $47M; +170% Q/Q; FY2014
Sales ($M)
; ;sales $70M
– Continued acceleration in Rx and revenue following psoriasis launch
– Leading branded share in PsA new patientLeading branded share in PsA new patient starts
• Long term data support clinical profile– Sustained clinical response over 2 years in
patients with active PsA$47
patients with active PsA
• Geographic Expansion:– EC approval for PsO and PsA on January 16th– Early launch countries include UK, Germany $18y , y
and Nordic countries, additional throughout 2015
– Approvals in Australia, Switzerland (PsO and PsA) and Canada (PsA) in 2015
$5
$18
Q2:14 Q3:14 Q4:14
30
– PsO and PsA approvals in Japan and other regions 2016 and beyond
Q2:14 Q3:14 Q4:14US
Initiated GED-0301 Registration Program
• Broad, multi-trial pivotal program underway
– Over 2 000 patients expected to enroll GED-0301 Registration ProgramOver 2,000 patients expected to enroll
– All trials will run in parallel
– Designed to support global registrations CD-001: Endoscopic Outcomes 12 wk Ind 52 wk Obs 24 wk Ext
Initiating
• Registration-enabling endoscopy trial initiated
– Evaluates endoscopic changes at week 12
– Includes additional analyses of clinical i i
CD-002 : 52 Wk Treat Through
CD-003 : 52 Wk Treat Through
12 wk Ind. 52 wk Obs. 24 wk Ext
InitiateMid-15E
remission
• Initiate 2 additional trials in mid-15E
– 52-week “treat-through” designCD-002 and CD-003:– Primary endpoint measuring CDAI at week 4
• Data possible beginning in 2017
• Developing registration clinical program in d l t C h ’ di
Primary endpoint measuring CDAI at week 4– Major secondary endpoints: endoscopic
changes, CDAI improvement over time, and Patient Reported Outcomes 2 (PRO2)
adolescent Crohn’s disease
31
Full-Year 2015 I&I Franchise Outlook
First full year of launch in U.S. and Europe Expansion in key geographies
Maximizing the OTEZLA® Opportunity
Expansion in key geographies Complete enrollment in the Ph II trial for atopic dermatitis
Moving GED-0301 Forward
Complete enrollment of registration-enabling endoscopy trial in Crohn’s disease Initiate enrollment in Ph III trials in Crohn’s disease
Moving GED 0301 Forward
a e e o e a s C o s d sease Initiate clinical program in ulcerative colitis Publication of Ph II trial in Crohn’s disease in a major medical journal
Complete Ph IIb enrollment for sotatercept in ESRD patients with anemia
New Products Furthering the I&I PipelineNew Products Furthering the I&I Pipeline
32
Complete Ph IIb enrollment for sotatercept in ESRD patients with anemia Complete enrollment in Ph IIa trial with CC-220 in patients with SLE
Mark Alles
Key Milestones – Full-Year 2015
Franchise Milestone ExpectedTiming
• Regulatory decisions on REVLIMID® for NDMM in the U.S. and EU Q1
• Regulatory 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 H1
• Initiate enrollment in REVLIMID® Ph III ROBUST trial in DLBCL H1Initiate enrollment in REVLIMID Ph III ROBUST trial in DLBCL H1
• EU regulatory decision on ABRAXANE® in NSCLC H1
• Regulatory decision on POMALYST® for RRMM in Japan H1
• Complete enrollment in REVLIMID® Ph III CONTINUUM trial in CLL H2
Hematology& Oncology
• CHMP opinion on VIDAZA® for elderly AML H2
• Advance CC-122 in Ph I/II trials in DLBCL H2
• Initiate sotatercept / luspatercept in Ph III trial in beta-thalassemia H2
• Initiate pivotal program with AG-221 in AML with IDH-2 mutation H2Initiate pivotal program with AG 221 in AML with IDH 2 mutation H2
• EU regulatory decision on OTEZLA® in PSOR and PsA Q1
• Complete enrollment in GED-0301 registration-enabling endoscopy trial H2
• Initiate enrollment in GED-0301 Ph III trials in Crohn’s disease H2I & I• Initiate GED-0301 in clinical program in ulcerative colitis H2
• Complete enrollment in CC-220 Ph II trial in SLE H2
34
Q4 and Full-Year 2014 Conference Call
J 29 2015January 29, 2015
Reconciliation Tables
Reconciliation Tables
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Reconciliation Tables
Explanation of adjustments:Explanation of adjustments:(1) Exclude share-based compensation expense totaling $128.4 for the three-month period ended December 31, 2014 and $98.4 for the
three-month period ended December 31, 2013. Exclude share-based compensation expense totaling $447.6 for the twelve-month period ended December 31, 2014 and $325.8 for the twelve-month period ended December 31, 2013.
(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-weightedp p ( ) p g p y g
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) and Celgene Avilomics Research, Inc. (Avila).(6) Exclude changes in the fair value of contingent consideration related to the acquisitions of Gloucester, Abraxis, Avila and
Nogra Pharma Limited.(7) Exclude impairment of royalty receivable asset that was received in April 2011 as partial consideration in the sale of the non-core
assets obtained by Celgene in the acquisition of Abraxis.(8) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain
other non-operating tax adjustments, including the effects of acquisition related matters, adjustments to the amount of unrecognized tax benefits, and nonrecurring items connected with the launch of new products.
39
Reconciliation Tables
come
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Return on Invested Capital Calculation
Return on Invested Capital (ROIC)(amounts in thousands) 2014 2013 2012 2011 2010 2009 2008Operating income 2,519,000 1,808,900 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) 2,519,000 1,808,900 1,746,442 1,442,753 989,635 841,526 578,851
Effective tax rate 14% 13% 13% 7% 13% 20% 24%Operating income after tax 2,164,539 1,575,056 1,512,428 1,339,017 860,221 669,930 439,272
Total equity 6,524,796 5,589,900 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 1,979,510 Total debt 6,871,632 4,741,269 3,079,792 1,802,269 1,247,584 - -
Total capital 15,375,938 12,310,679 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838
Total capital beginning of period 12,310,679 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838 3,040,499 Total capital end of period 15,375,938 12,310,679 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838
Average total capital 13,843,309 11,532,224 10,024,138 9,258,536 7,798,341 5,922,477 4,255,669
ROIC 15.6% 13.7% 15.1% 14.5% 11.0% 11.3% 10.3%
Return on Invested Capital (ROIC), Net of Cash(amounts in thousands) 2014 2013 2012 2011 2010 2009 2008Operating income 2,519,000 1,808,900 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) 2,519,000 1,808,900 1,746,442 1,442,753 989,635 841,526 578,851
Effective tax rate 14% 13% 13% 7% 13% 20% 24%Operating income after tax 2,164,539 1,575,056 1,512,428 1,339,017 860,221 669,930 439,272
Total equity 6,524,796 5,589,900 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 1,979,510 Total debt 6,871,632 4,741,269 3,079,792 1,802,269 1,247,584 - - Less Cash and Marketable Securities (7,546,633) (5,686,989) (3,900,270) (2,648,154) (2,601,301) (2,996,752) (2,222,091)
Total capital 7,829,305 6,623,690 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747
Total capital beginning of period 6,623,690 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747 3,040,499 Total capital end of period 7,829,305 6,623,690 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747
Average total capital 7,226,498 6,738,595 6,749,926 6,633,809 4,999,315 3,313,056 3,144,623
41
ROIC, Net of Cash 30.0% 23.4% 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
Worldwide Other Net Product Sales
Net Product Sales(in $ Millions)
Q4:14 ∆ vs.Q4:13 FY2014 ∆ vs.
FY2013( )
THALOMID® Total $57 ↓6% $221 ↓10%
U.S. $41 ↓4% $152 ↓9%
International $16 ↓12% $69 ↓12%International $16 ↓12% $69 ↓12%
ISTODAX® Total $17 ↑23% $66 ↑21%
U.S. $16 ↑24% $62 ↑23%
International $1 ↓0% $4 ↑2%International $1 ↓0% $4 ↑2%
Authorized Generic of VIDAZA® Drug Product Total (U.S.) $15 ↓33% $78 NA
Other Total $4 NA $9 NA
U.S. $3 NA $7 NA
International $1 NA $2 NA
43
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-020
Trial Name MM-015FIRST®
Phase III III
Target Enrollment 459 1,623
Design
Arm A: REVLIMID® (10mg)/melphalan/ prednisone for 9 cycles followed by REVLIMID® (10mg) maintenance to
disease progressionArm B: REVLIMID® (10mg)/melphalan/
prednisone for 9 cycles followed by placebo
Arm A: REVLIMID® (25mg)/low-dose dexamethasone until disease progression
Arm B: REVLIMID® (25mg)/low-dose dexamethasone for 18 4-week cycles g prednisone for 9 cycles followed by placebo
maintenance to disease progressionArm C: Melphalan/prednisone for 9 cycles
followed by placebo maintenance to disease progression
(72 weeks)Arm C: THALOMID®/melphalan/prednisone
for 12 6-week cycles (72 weeks)
P i E d i tPrimary Endpoint Progression Free Survival Progression Free Survival
Status
Study met primary endpoint July 2009Data presented at ASH 2009 with follow-up data at ASCO 2010, ASH and IMW 2011,
ASH 2012 and IMW 2013 PFS2 presented
Enrollment completeTrial met primary endpoint for PFS
Final PFS and interim OS presented at ASH 2012 and IMW 2013. PFS2 presented at ASH 2013. Published in NEJM May 2012
Follow-up continuing
pASH 2013
REVLIMID® for NDMM filed in U.S. and EU
47
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.
Published in NEJM May 2012Follow-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
48
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance Post-VMP induction
Trial Name MM-026Trial Name
Phase III
Target Enrollment 350
2:1 randomization
Design
2:1 randomizationInduction with
Melphalan/prednisone/bortezomib (VMP) for 6-9 cycles
Arm A: REVLIMID® (10mg) d 1-21 for 28 day cyclefor 28-day cycle
Arm B: Placebo d 1-21 for 28-day cycle
Primary Endpoint Progression Free Survival
Status Trial enrollingStatus Trial enrolling
49
REVLIMID® Multiple Myeloma Late Stage Programs
Patient Population Maintenance in ASCT EligibleTrial Name MYELOMA XI
Phase 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)
Design
( g) y ( g) ( g)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
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 Survival
StatusTrial enrolling
Possible interim data in mid-2015E
50
POMALYST®/IMNOVID® Multiple Myeloma Late Stage Programs
Patient Population RRMM
Trial NameMM-007
Trial NameOPTIMISMM
Phase III
T t E ll t 782Target Enrollment 782
Design
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 Survivaly p g
Status Trial enrolling
51
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 2015Trial enrolling
52
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
Target Enrollment 488 460
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
53
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
Target Enrollment 450 400
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
54
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 complete
55
Status Enrollment complete Enrollment complete
REVLIMID® Lymphoma Late Stage Programs
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 soon
56
REVLIMID® Lymphoma Late Stage Programs
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
Status Trial enrolling
57
ABRAXANE® Solid Tumor Late Stage Programs
Patient PopulationMaintenance After Induction in
Squamous Non-Small Cell Lung Cancer
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
Trial Name NSCL-003 PANC-003
Phase III III
Target Enrollment 540 800
Induction: ABRAXANE® (100 mg/m2) D 1, 8,and 15 / Carboplatin (6 mg min/mL) D 1 for
4 21-day cycles A A ABRAXANE® (125 / 2) / G it bi
Design
4 21-day cyclesMaintenance:
Arm A: ABRAXANE® (100 mg/m2) D 1 and 8 plus BSC until disease progression –
21-day cycle
Arm A: ABRAXANE® (125 mg/m2) / Gemcitabine (1000 mg/m2) D 1, 8 and 15 for 6 28-day cyclesArm 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
58
Status Trial enrolling Trial enrolling
ABRAXANE® Solid Tumor Late Stage Programs
Patient Population First-Line Triple Negative Metastatic Breast Cancer
tnAcity™Trial Name
tnAcity™ABI-007-MBC-001
Phase II/III
Target Enrollment 240/550Target Enrollment 240/550
Phase IIArm A: ABRAXANE® 1(25mg/m2) / Gemcitabine
(1000 mg/m2) D 1 and 8 – 21-day cycleArm B: ABRAXANE® (125mg/m2) / Carboplatin
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® armp
Arm 2: Gemcitabine (1000 mg/m2) / Carboplatin AUC 2 IV, D 1 and 8 – 21-day cycle
Primary Endpoint Progression Free Survival
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Status Trial enrolling
I&I Late Stage Programs
Patient Population
Untreated Moderate-to-Severe
Late Stage Psoriatic Arthritis
Moderate-to-Severe Plaque Psoriasis Active Behçet’s Disease
Molecule OTEZLA® OTEZLA® OTEZLA®
Trial Name PSA-006 PSOR-010BCT-002RELIEFTM
Phase III IIIb III
Target Enrollment 214 240 204
Arm A: OTEZLA® single agent (30mg)
Arm A: OTEZLA® (30 mg) twice daily
Arm A; Placebo for 12 weeks followed by 30mg OTEZLA®
i d il f 2 kDesign(30mg)
twice dailyArm B: Placebo
Arm B: Etanercept (50 mg subcutaneous) once weekly
Arm C: Placebo
twice daily for 52-weeksArm B: 30mg OTEZLA® twice
daily for 64 weeks
Primary ACR 20 t W k 16 PASI75Area under the curve (AUC) for th b f l l fPrimary
Endpoint ACR 20 at Week 16 PASI75 the number of oral ulcers from baseline through week 12
Status Enrolling Enrollment complete Trial enrollingStatus g p g
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