credit suisse healthcare conference · 2019-08-22 · 100 (cdai
TRANSCRIPT
Credit Suisse Healthcare Conference
N b 11 2014November 11, 2014
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 measures are non-GAAP and should be considered in addition to but not as a substitute for the information preparedGAAP and should be considered in addition to, but not as a substitute for, the information preparedin accordance with U.S. GAAP. We typically exclude certain GAAP items that management does notbelieve affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. Further informationrelevant to the interpretation of adjusted financial measures, and reconciliations of these adjustedfi i l t th t bl GAAP b f d C l ’ b it t
2
financial measures to the most comparable GAAP measures, may be found on Celgene’s website atwww.Celgene.com in the “Investor Relations” section.
Our Mission and Vision
Celgene is building a preeminent global biopharmaceutical company focused on the
discovery, development and commercialization of innovative therapies for unmet medical needs in
cancer and immune-inflammatory diseases
3
A Leading Global Biopharmaceutical Company
Global, FullyIntegrated
Portfolio ofLeading Products
Unique R&DCapability
• Operations in >60 countries
• Sales in >70 countries
• Manufacturing facilities
• Expertise in hematology, oncology, and immunology
• Diverse technology • Manufacturing facilities in U.S. and EU
• Key research facilities in NJ, CA, MA & Spain
• ~6 000 employees
platforms
• Rich pipeline– 30 programs in
preclinical development– 22 treatments in• ~6,000 employees
globally22 treatments in clinical trials
– 30 pivotal / phase III programs underway
4
Proven Business Model – Moving into its Sweet Spot
Proven Model… Entering its Sweet Spot
1. Unmetneeds
2. Differentiatedproducts Sustainable top and bottom
line growthline growth
P&L operating leverage
Growing cash flowg
More diversified drivers –lower risk profile
3. Leverageinfrastructure
4. Leadingperformance
Growth primarily organic, highly accretive new products
5
Strong, Consistent Revenue and Earnings Growth
Net Product Sales1
($B)EPS3
($)
$2.98$6.4
($B) ($)
25%
$1.89
$2.45
$4.7
$5.4~25%CAGR2 ~31%
CAGR2
$1.04
$1.40$2.6
$3.5
6
2009 2010 2011 2012 2013
Notes: 1) Net Product Sales adjusted for 2008-2011 2) CAGR calculated using 2008 to 2013 3) Adjusted EPS reflects 2014 stock split
2009 2010 2011 2012 2013
Our Business Model Is Proven and Scalable
51.0%51.0%
41.0%41.0%
23 3%23 3%R&DR&D26.0%26.0%23.3%23.3%
21.0%21.0%
R&DR&DSG&ASG&A25.4%25.4%
2009 2010 2011 2012 2013 YTD 2014
4.8%4.8%COGSCOGS8.0%8.0%
7
Adjusted
2009 2010 2011 2012 2013 YTD 2014
Focused on Returns
30.0%
$14 0
$16.0 ROIC
20.0%
25.0%
$10 0
$12.0
$14.0
15.0%
$6 0
$8.0
$10.0
Bill
ion
5.0%
10.0%
$2 0
$4.0
$6.0$ B
Average Invested Capital
0.0%$0.0
$2.0
2008 2009 2010 2011 2012 2013 2014(TTM)
Average Invested Capital
Capital Base Excluding Cash* Capital Base* ROIC Excluding Cash* ROIC
8
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
Powerful Drivers. Delivering Sustainable Growth.
Our Growth Outlook to 2017
Driving Sustainable Growth
9
Strong Momentum in Core Franchise
Expected 2017 Sales
$7.0B
$
11
$1.5B
Total Hematology $9.5B-$10B
22
$1.5B-$2B
$1.5B-$2B
33
44
Total $13B-$14B
10
R E V L I M I D ® :
Execution and New Indications Accelerate Growth11 2 3 41Key Growth DriversKey Growth Drivers
• Increased duration of therapy and market share growth in RRMM Sales ($B)
1 2 3 4
market share growth in RRMM
• NDMM expansion on-track– EU dossier submitted in February 2014– U.S. submitted in April 2014
Sales ($B)
$7.013%CAGR
• Future drivers advancing – MCL-002 and MDS-005 met endpoint– REMARC phase III in DLBCL first-line
maintenance completed enrollment $4.3p– RELEVANCE phase III in FL completed
enrollment– MAGNIFYTM phase III trial in RR indolent
lymphoma and AUGMENTTM phase III trial in RR FL enrolling
– CLL-002 (CONTINUUM) phase III maintenance trial continues to enroll
2013 2015E 2017E
11
P O M A L Y S T ® / I M N O V I D ® :
Establishing a New Standard in RRMM1 2 3 4
Key Growth DriversKey Growth DriversSales ($B)
1 2 3 4
• Global launch is ongoing– U.S. approval on February 8, 2013– EU approval on August 5, 2013;
reimbursement in key markets
Sales ($B)
$1.5
reimbursement in key markets expected throughout 2014
– Additional global approvals expected
• Increase duration of therapy
35%CAGR 49%CAGR
– Potential strategies to move into 2nd line multiple myeloma
• Combination strategies withProteasome inhibitors $0 3– Proteasome inhibitors
– Monoclonal antibodies– HDAC inhibitors
$0.3
2013 2015E 2017E
12
A B R A X A N E ® :
New Indications for NSCLC & PanC Sustain Growth41 2 3 4
Key Growth DriversKey Growth DriversSales ($B)
41 2 3 4
$1.5-$2.0
• Establishing a new standard of care in metastatic pancreatic cancer
– U.S. approval on September 6, 2013EU approval on December 23 2013
Sales ($B)
– EU approval on December 23, 2013– Additional global approvals expected
• Expanding into new patient segments in core indications
28%CAGR*
$0.65
g– Ph III trials for triple-negative mBC,
adjuvant PanC, and NSCLC maintenance
• Expanding into new cancers in 2014• Expanding into new cancers in 2014– Ph II trials for colorectal and ovarian– Ph I/II combo with anti-PDL-1/PD-1
13
2013 2015E 2017E
Notes: *CAGR calculated using 2017 midpoint
O T E Z L A ® :
Launching in PsA and Psoriasis in 20141 2 3 4
Key Growth DriversKey Growth Drivers Large Underserved
1 2 3 4
PsoriaticA th iti
Patient Populations
~1 0MPsA
• Approvals expected in 2014– U.S.: PsA approved in March; psoriasis
in September– EU: PsA and psoriasis in Q1:15E
Arthritis 1.0M
P i i
• U.S. launch progressing– PsA prescription trends accelerating– Key performance indicators demonstrate
attractive launch dynamics~2.5M
Psoriasis (moderate to severe)
attractive launch dynamics– Sales team for psoriasis executing
• Optimize OTEZLA® opportunity– Ph II trials in IBD and atopic dermatitis
~2.5MAnkylosingSpondylitis
Ph II trials in IBD and atopic dermatitis initiating
– QD formulation
14
Leading Indicators Favorable for Future Growth
PsA Source of Business(based on last therapy prior to OTEZLA®)
Share of New Treatment Starts in PsA
40%
50%
20%
26%17%
19%Biologics
Oral DMARDs
Corticosteroid0%
10%
20%
30%
D th f P ibiP ti t A
26%18%
NSAID
Naïve(No tx in prior 12 months)
0%March
30389
April30690
May34489
June34382
July33583
Aug31481
Sept30284
ENBREL SIMPONI HUMIRA CIMZIASTELARA REMICADE DMARDs OTEZLA
Depth of PrescribingNumber of TRx per Trialist
28%
Patient AccessU.S. National Commercial Formulary Access
Formulary Covered 28%
17%55%
1 TRx2 TRx≥ 3 TRx
98%No Step Through Biologics78%
Note: Symphony data is subject to restatement; Source: Symphony Health Solutions Brand Impact Survey, Sept 201415
0% 20% 40% 60% 80% 100%
GED-0301 Development Highlights
Percentage of Patients AchievingClinical Remission
(CDAI <150 at Day 15 and Maintained for ≥2 weeks)D Di i i
80
100
(CDAI <150 at Day 15 and Maintained for ≥2 weeks)
*P<0.0001 vs. placebo
*
Data Dissemination• First phase II presentation
occurred at UEGW (Vienna) –oral presentation Oct 21
5565
40
60
80*
p• Study results expected to be
published in prestigious medical journal
P U d t10 12
0
20Program Updates• Health authority meetings
underway• Phase III clinical development
The rates of adverse events (AEs) and serious
Placebo GED-0301 10 mg/dayGED-0301 40 mg/day GED-0301 160 mg/day
Phase III clinical development program expected to initiate by year end
16
The rates of adverse events (AEs) and serious adverse events (SAEs) were similar across groups
Source: Presentation at the 22nd United European Gastroenterology Week; October 18-22, 2014; Vienna, Austria.
Powerful Drivers. Delivering Sustainable Growth.
Our Growth Outlook to 2017
Driving Sustainable Growth
17
Complementing Our Internal Strengths with Selected External Partnerships
18
Advancing Novel Programs into Phase I
Key Phase I Studies Planned/Underway:MOR 202 in RRMM and AML
ACY 1215 in RRMMACY-1215 in RRMMEPZ-5676 in MLL-r
AG-221 in IDH2m AMLPDA-002 in PAD
Demcizumab in Solid TumorsCC-90001 in FibrosisCC 90001 in Fibrosis
Novel-Novel DLBCL Combinations
DC IND
19
≥≥3 3 new INDs new INDs targeted per targeted per yearyear
Expanding Phase II Program with New Entities
Over 100 Phase II Trials Planned/Underway:CC-486 Priming in Solid Tumors
CC-122 in Hematologic MalignanciesCC-292 in CLL, NHL and RA
Sotatercept (ACE 011) in MDS Anemia CKDSotatercept (ACE-011) in MDS, Anemia, CKDACE-536 in MDS, Anemia
CC-220 in SLE, Scleroderma and SarcoidosisVTX-2337 in Solid Tumors
DC IND
20
Significant data flow expected in 2014/2015Significant data flow expected in 2014/2015
Broadening Phase III Program
Over 30 Phase III Trials Planned/Underway:REVLIMID® in NDMM NHL and CLLREVLIMID® in NDMM, NHL and CLL
GED-0301 in Crohn’s diseaseABRAXANE® in TNBC, Adjuvant PanC, NSCLC
CC-486 in MDS and AMLSotatercept / Luspatercept (ACE-536) in β-Thalassemia
OTEZLA® in BehçetsOTEZLA in Behçets
DC IND
21
Sustainable growth beyond 2017Sustainable growth beyond 2017
Our Deep Clinical and Development Pipeline
22 Programs in Clinical Developmentg p
100+ Celgene-sponsored Clinical Trials
28 000 E ll d P ti t~28,000 Enrolled Patients
Over 50 Indications
DC IND
22
Accelerating Growth Outlook Through 2017
Net Product Sales($B)
EPS2
($)
$13-$1421%CAGR1
~$7.5026%CAGR
$8.5-$9.5$4.50-$4.75
$6.4$2.98
23
Notes: 1) CAGR calculated using 2017 midpoint 2) Adjusted EPS reflects 2014 stock split
2013 2015E 2017E 2013 2015E 2017E
T H E C E L G E N E S T O R Y
Powerful Business Model, Driving Sustainable Growth
Leveraging Strong Growth Sustainable Trajectory g gPowerful Model
gto 2017
j yBeyond 2017
Leveraging model 4 blockbuster 22 programs– all metrics
improving
More diversifiedl i k
products by 2017
Adjusted EPS expected to grow at 26% CAGR
>50 indications
100+ clinical trials– lower risk 26% CAGR
5-10years
26%CAGR
Adjusted EPS
2013 2015E 2017E
years
24
2013 2015E 2017E
Key Milestones – 2014
Business Milestone Timing
• Submit REVLIMID® for NDMM in the U.S. and EU Q1
Ph III VIDAZA® d t i AML (AZA AML 001) Q2
Hematology
• Ph III VIDAZA® data in AML (AZA-AML-001) Q2
• Initial Ph I data from AZA-ST-001 (CC-486 priming) Q4*
• Ph III REVLIMID® data in non-del 5q MDS Q4*
• Ph I MOR202 data in RRMM H2 → 2015Hematology& Oncology
• Ph I MOR202 data in RRMM H2 → 2015
• Ph II Sotatercept (ACE-011) data in MDS Q4*
• Ph II luspatercept (ACE-536) data in MDS Q4*
• Ph II luspatercept (ACE-536) data in β-thalassemia Q4*uspate cept ( C 536) data β t a asse a Q
• Initial Ph I/II CC-292+REVLIMID® in CLL H2 → 2015
• Ph Ib demcizumab combination data in PanC and NSCLC Q3
• OTEZLA® approval in the U.S. for PsA Q1
I & I
• Ph III OTEZLA® data in ankylosing spondylitis Q2
• OTEZLA® approval in the U.S. for psoriasis Q3
• OTEZLA® CHMP opinion for PsA and psoriasis Q4*p p
• Ph II Sotatercept (ACE-011) data in renal anemia Q4*
25
* Expected
Credit Suisse Healthcare Conference
N b 11 2014November 11, 2014
Reconciliation Tables
010200
9
880.5
776
.7$
(8.2)
(12.7)
(15.9)
-
(0.9)
-
6.8
4.4
34.
7
0.4
9.8
8.3
9.3
-
(0.3)
(0.6)
82.1
64.8
121
.2
34.5
7.3
-
-
-
-
93.9
74.6
15.1
-
-
-
203.2
83.
4
9.7
-
37.
5
-
-
-
-
1.3
1.4
(1.4)
-
-
-
(0.3)
-
(174.9
)
(63.9)
1,310.
5
971.3
$
1.42
1.06
$
mber
31,201
120
1,318.
1$
$
(5.4)
(21.3)
(1.7)
9.8
90.
3
)9.9
13.2
-
104.7
128
.5
8.7
118
.0
-
102.7
15.1
9.8
289.2
(147.5
)
5.1
-
-
0.6
2.0
(2.
9)
(0.7)
)(29
3.3)
1,7
52.9
$
$
1.92
$
$
iaries
Net In
come
Twelv
e Mont
hs En
ded De
cem201
3201
2
1,449.
9
1,456.
2$
-
-
-
-
-
-
18.5
12.4
-
-
-
(1.
6 )
-
-
-
-
144.7
102.4
575.8
189.5
-
-
-
122.5
-
-
162.6
116.2
-
-
-
-
262.8
194.5
171.1
166.4
-
2.6
-
-
80.0
-
-
-
-
-
-
-
-
-
(302.3
)
(198.6
)
2,5
63.1
2,1
62.5
$
3.10
2.51
$
ne Co
rporat
ion an
d Sub
sidi
on of
GAA
P to A
djuste
d N(In
millio
ns, ex
cept pe
r shar
e data
)
YTD Q
2 2014 877
.5$
$
(1)-
(1)-
(2)-
12.0
(3)-
(2)-
(2)-
(4)-
92.8
(5)323
.0
(2)-
(6)-
(7)-
103.0
(8)
25.0
(2)
-
(9)
-
131.0
: n(10
)9.5
(10)
-
(11)
-
(12)
-
(4)
-
(2)
-
-
(2)-
(13)
(121.0
)
1,452.
8$
$
Adjus
ted*
1.80
$
$
Celge
nRe
concili
ati
able to
Celge
ne - G
AAP
justme
nts:
sales:
rod
ucts e
xited it
to be
exited
:n e a
greem
ents a
nd oth
er rev
enue:
on-cor
e reve
nues
s sold
(excl
uding
amort
ization
intangi
ble as
sets):
ed com
pensat
ion ex
pense
nd Ph
armion
invent
ory ste
p-up
exited
it to b
e exite
d:n inte
rcomp
any ro
yalty
d deve
lopme
nt:ed
compen
sation
expen
seolla
boratio
n expe
nseon-
core a
ctivitie
smp
airment
sof
VIDA
ZA ro
yalty o
bligatio
n
ral and
admin
istrativ
e:ed
compen
sation
expen
set of
contin
gent ob
ligation
on-cor
e activ
ities
pricing
settle
ment
of acq
uired in
tangib
le asse
ts:
elated
charg
es and
restru
cturing
, net:
fair va
lue of
contin
gent co
nsider
ation
n and
restru
cturing
costs
proces
s resea
rch an
d deve
lopme
nt
e (exp
ense),
net:
ating a
sset im
pairm
ent, In
c. equi
ty meth
od los
son-
core a
ctivitie
sive
stment
of no
n-core
activi
ties
ing int
erest:
on-cor
e activ
ities
x adju
stment
sabl
e to Ce
lgene
- Adju
sted
mmon
share
attribu
table t
o Celg
ene -
27
Net in
come a
ttribut
a
Befor
e tax a
dj N
et prod
uct s
S
ales o
f pr
Pharm
ion
Ab
raxis
Colla
borativ
e
Abra
xis no
Cost
of go
od
of acq
uired
S
hare-b
ase
Abra
xis an
P
roduct
s e
Ph
armion
Abrax
is
Entr
eMed
Rese
arch a
n d
Shar
e-base
U
pfront
co
Abra
xis no
IP
R&D i
m
Purc
hase o
Selli
ng, ge
ner
Shar
e-base
S
ettlem
ent
Abra
xis no
C
anadia
n p
Amo
rtizatio
n
Acqu
isition
r e
Chan
ge in
Acqui
sition
Acqu
ired in-
p
Othe
r incom
e
Non-
opera
E
ntreM
ed
Abra
xis no
G
ain on
div
Non-
contro
lli
Abra
xis no
Net in
come ta
xNe
t incom
e attri
buta
Net in
come p
er com
Basic
Reconciliation Tables
Celgene Corporation and SubsidiariesR ili ti f GAAP t Adj t d N t I
Explanation of adjustments:(1) Exclude sales related to non-core former Pharmion Corp., or Pharmion, and Abraxis BioScience Inc., or Abraxis products to be divested.(2) Exclude the estimated impact of activities arising from the acquisition of Abraxis that are not related to core nab technology and
were divested in 2011, including other miscellaneous revenues, cost of goods sold (excluding amortization of acquired intangible assets), operating
Reconciliation of GAAP to Adjusted Net Income
expenses and other costs related to such activities. Exclude the net (benefit) cost of activities arising from the acquisition of Pharmion that are planned to be exited.
(3) Exclude acquisition-related inventory step-up adjustments to fair value which were expensed for Abraxis in 2011 and 2010 and Pharmion in 2009 and 2008.(4) Exclude the Company's share of EntreMed, Inc. THALOMID royalties and equity losses. (5) Exclude upfront payments for research and development collaboration arrangements and purchases of intellectual property for unapproved products.(6) Exclude in-process research and development, or IPR&D, impairments.(7) Exclude the purchase of VIDAZA royalty obligations related to unapproved forms.(8) Exclude pricing settlement with the Patented Medicine Prices Review Board of Canada related to sales of THALOMID.(9) Exclude acquisition related charges and restructuring, including changes in the fair value of contingent consideration, related to the acquisitions of
Gloucester, Abraxis and Avila.(10) Exclude the IPR&D write-off related to the acquisition of Pharmion Corp. in 2008.(11) Exclude impairment of royalty receivable asset that was received in 2011 as partial consideration in the sale of the non-core assets obtained by Celgene in the
acquisition of Abraxis.(12) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments,
including one-time effects of changes in tax law, acquisition related matters, adjustments to the amount of unrecognized tax benefits and deferred taxes on unremitted foreign earnings.
28
Return on Invested Capital Calculation
Return on Invested Capital (ROIC)2014 (TTM) 2013 2012 2011 2010 2009 2008
Operating income 2,093,100 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) 2,093,100 1,808,900 1,746,442 1,442,753 989,635 841,526 578,851
Effective tax rate 13% 13% 13% 7% 13% 20% 24%1 826 697 1 575 056 1 512 428 1 339 017 860 221 669 930 439 272Operating income after tax 1,826,697 1,575,056 1,512,428 1,339,017 860,221 669,930 439,272
Total equity 5,768,368 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 6,837,287 4,741,269 3,079,792 1,802,269 1,247,584 - -
Total capital 14,585,165 12,310,679 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838
Total capital beginning of period 12,508,388 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838 3,040,499 Total capital end of period 14 585 165 12 310 679 10 753 769 9 294 506 9 222 566 6 374 116 5 470 838Total capital end of period 14,585,165 12,310,679 10,753,769 9,294,506 9,222,566 6,374,116 5,470,838
Average total capital 13,546,777 11,532,224 10,024,138 9,258,536 7,798,341 5,922,477 4,255,669
ROIC 13.5% 13.7% 15.1% 14.5% 11.0% 11.3% 10.3%
Return on Invested Capital (ROIC), Net of Cash2014 (TTM) 2013 2012 2011 2010 2009 2008
Operating income 2,093,100 1,808,900 1,746,442 1,442,753 989,635 841,526 (1,464,218) Certain charges (1) 2 043 069Certain charges (1) 2,043,069
Operating income (non-GAAP for 2008) 2,093,100 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 1,826,697 1,575,056 1,512,428 1,339,017 860,221 669,930 439,272
Total equity 5,768,368 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 6 837 287 4 741 269 3 079 792 1 802 269 1 247 584 - -Total debt 6,837,287 4,741,269 3,079,792 1,802,269 1,247,584 Less Cash and Marketable Securities (6,860,700) (5,686,989) (3,900,270) (2,648,154) (2,601,301) (2,996,752) (2,222,091)
Total capital 7,724,465 6,623,690 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747
Total capital beginning of period 6,661,075 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747 3,040,499 Total capital end of period 7,724,465 6,623,690 6,853,499 6,646,352 6,621,265 3,377,364 3,248,747
Average total capital 7,192,770 6,738,595 6,749,926 6,633,809 4,999,315 3,313,056 3,144,623
ROIC, Net of Cash 25.4% 23.4% 22.4% 20.2% 17.2% 20.2% 14.0%
29
,
(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
31
Celgene Pipeline
32
Celgene Pipeline
33