Q2 2015 Conference Call€¦ · This presentation contains forward-looking statements, which are...
Transcript of 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%
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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)
$$1,444, ; ,
• Strong U.S. Q2 TRx and NRx trends• Market shares and duration of treatment are
strong across the world$540 $525
$532 $571
$1,300 $1,322 $1,343
• Progress on 2015 commercial drivers– On-track with NDMM reimbursement
discussions in EU; EU G5 by Q1:16– Execution of launch for NDMM in U.S. and EU
R i F d l RRMM i b i Q2
$540 $525
– Russia Federal RRMM reimbursement in Q2– Data at ASCO to support the evolving triplet
regiment landscape with REVLIMID® as backbone
• Future growth drivers advancing$760 $797 $811 $873
Future growth drivers advancing Geographic expansion in Latin America
continues Updates at ASCO and EHA on MM-020
survival data and “FLASH” meta-analysis in FL Q3:14 Q4:14 Q1:15 Q2:15
20
NDMM approval in Japan by YE15U.S. ROW
Q2 2015 POMALYST®/IMNOVID® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
$202
$235
• Q2:15 sales $235M; +46% Y/Y 18% Q/QSales ($M)
$70 $70
$91 $181
$202 $199• Q2:15 sales $235M; +46% Y/Y,18% Q/Q
• Positive trends in U.S. and EU market share
• Progress on 2015 growth drivers$63
Progress on 2015 growth drivers Reimbursement in Italy; Finland, Ireland
and Netherlands expected in Q3 Launch in Japan has begun
Strong growth in Canada; Launching in
$118 $132 $129 $144
Strong growth in Canada; Launching in Australia
• Future growth drivers advancing U.S. label update with OS
Q3:14 Q4:14 Q1:15 Q2:15
p Phase II trials with checkpoint inhibitors,
HDAC inhibitors, proteasome inhibitor enrolling
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U.S. ROW
Q2 2015 ABRAXANE® Sales Summary
Current Results & Future Growth DriversCurrent Results & Future Growth Drivers
• Q2:15 sales $244M; +13% Y/Y 9% Q/QSales ($M)
$64 $74 $212
$236$223
$244Q2:15 sales $244M; +13% Y/Y, 9% Q/Q
• Continued growth in U.S. and EU in pancreatic cancer
• Progress on 2015 growth drivers$61
$$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
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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
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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
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– 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
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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iesd S
tatem
ents
of Inc
o mud
ited)
pt per
share
data)
June 3
0,Th
ree-M
onth P
eriods
urities
n of lo
ng-ter
m deb
t
Celge
ne C
orpo
ratio
onde
nsed
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solid
ate (Unau
(In m
illion
s, exce
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luding
amort
ization
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sets)
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adminis
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cquire
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d (gai
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and ex
penses
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e, net
) xpense
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axes
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e shar
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tems:
equiva
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mark
etable
secu
borrow
ings a
nd cur
rent p
ortion
debt
holder
s' equi
ty
Co
35
Net p
roduct
sales
Other
reven
ueTo
tal rev
enu
Cost o
f good
s sold
acquir
ed inta
Resea
rch an
d dev
Sellin
g, gene
ral an
Amort
ization
of a
Acqui
sition
relate
Total
costs a
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ting inc
ome
Intere
st and
inves
Intere
st (exp
ense
Other
incom
e (e x
Incom
e befo
re inc
Incom
e tax
provis
Net in
come
Net in
come p
er c
Basic
Dilute
d
Weigh
ted av
erage
Basic
Dilute
d
Balan
ce sh
eet it
Cash,
cash
eTo
tal ass
etsSh
ort-te
rm b
Long-
term
dTo
tal sto
ckh
Reconciliation Tables
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
riod
15 an
d $20
7.8 fo
r the
uces
ter), A
braxis
a Pha
rma L
imite
d.ati
ng ta
x adju
stmen
ts,
d to t
he ga
in on
the
ncial
mea
sure
s tha
t tha
t fac
ilitate
an
d sho
uld be
ex
clude
certa
in ua
l or n
on-
onth
Perio
ds E
nded
June
30,
2014
2015
597.8
1,0
7$
5.9
1
45.8
11
14.0
5 8
51.7
1 4
-
65.3
1 2
0.9
(1
(33.5)
(14
74
7.9
1,90
$
0.94
2
$
0.90
2
$
e 30,
2015
and $
103.4
for t
he
nth pe
riod e
nded
June
30, 2
01
izatio
n.er
Pharm
aceu
ticals
, Inc.
(Glou
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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
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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
REVLIMID® Multiple Myeloma Late Stage Programs
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
REVLIMID® Multiple Myeloma Late Stage Programs
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
Status Trial enrolling
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
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
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
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
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
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
53
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
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
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 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
Status Trial enrolling Trial enrolling
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
Status Trial enrolling Trial enrolling
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
Target Enrollment 214 204
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
Status Trial enrolling Trial enrolling
57