rhreport to the investment community eli lillyypy and...
TRANSCRIPT
R hReport to the
Investment Community
Eli Lilly and Companyy p y
June 30, 2011
1Investment Community Meeting June 30, 2011
Not for promotional use Copyright © 2011 Eli Lilly and Company
Safe Harbor Provision
This presentation contains forward-looking statements that are based on
management's current expectations, but actual results may differ materially
due to various factors. The company's results may be affected by such
factors as the risks and uncertainties in pharmaceutical research and
development; competitive developments; regulatory actions; litigation and
investigations; business development transactions; economic conditions;
and changes in laws and regulations, including health care reform. For g g , g
additional information about the factors that affect the company's business,
please see the company's latest Forms 10-K and 10-Q filed with the
Securities and Exchange CommissionSecurities and Exchange Commission.
The company undertakes no duty to update forward-looking statements.
2Investment Community Meeting June 30, 2011
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Bio-Medicines
Bryce D. Carmine
Executive Vice President
and President, Lilly Bio-Medicines
Report to the Investment Community
Eli Lilly and Company
3Investment Community Meeting June 30, 2011
Not for promotional use Copyright © 2011 Eli Lilly and Company
Eli Lilly and Company
June 30, 2011
Bio-Medicines Business PerformanceStrong executiong
Q1 Lilly Bio-Medicines Revenue*100% = $3.2 billion
Q1 Total Lilly Revenue100% = $5.8 billion
Cialis, $343Evista, $250Forteo, $197
i
Animal Health5% Europe,
Japan, $248 CA, AUS, NZ, $150
Cymbalta, $873
Other, $657Bio
Medicines54%
Oncology15%
Emerging Markets10%
U.S. &
$828
Zyprexa, $1,153
Diabetes16%
Puerto Rico, $1,937
• Strong financial performance
• Volume driven sales growth in Q1 2011 and in 2010
– 11% sales growth, excluding Zyprexa (8% inclusive of Zyprexa)
• Poised to capitalize on recent launches and longer patent life assets
4Investment Community Meeting June 30, 2011
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• Leverage growth in Japan – a key countercyclical growth driver
* Lilly sells the products listed in other countries and other products in the countries listed
Lilly Bio-Medicines NME PipelinePriority #1 – Deliver the pipeliney p p
New Chemical Entity (NCE)
New Biotech Entity (NBE)
Line Extensions
• Prioritized investments in Neuroscience & Autoimmune
• Opportunistic investments in Cardiovascular, Urology, Bone, Muscle & Joint
• Significant contributor to Lilly’s Phase 3 NME goals (10 NMEs by 2011)
Effient **ACS Med Mgmt
• Significant Phase 3 disclosures starting in 2012
• Expect 50% of revenue to come from biologics by the end of this decade
AMPAagitation in Alz’s
IL-17 MAbRA/Psoriasis
OpRAalcohol depend
JAK1/JAK2*RA
mGlu2 PotCysmigraine prev
NERIdepression
mGlu2/3 proschizophrenia
ACS Med Mgmt
TadalafilBPH/ED
ER betaBPH
CymbaltaPeds
Evacetrapibatherosclerosis
Sclerostin MAbosteoporosis
SARM/Tadalafilerectile dys
CB-2osteoarthritis
SolanezumabAlzheimer’s
BAFF MAbRA/Lupus
p
LiprotamaseEPI
Florbetapirβ-amyloid imaging
/
Phase 2 Phase 3 Reg Review
5Investment Community Meeting June 30, 2011
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* In collaboration with Incyte
** In collaboration with Daiichi Sankyo
Near-Term Growth OpportunitiesLeveraging long patent life assets and Japang g g p p
• Opportunities for growth:
– Cymbalta Chronic Musculoskeletal Pain
• Approved in the U.S., Canada1, Brazil2 & Mexico2
– Axiron for testosterone deficiency
– Tadalafil for BPH and ED
– Other opportunities:
• Forteo for osteoporosis & bone healing
Effi t ACS di l t• Effient – ACS, medical management
• Recent bolt-on acquisitions: Livalo, Amyvid, Liprotamase
• Japan – strong counter countercyclical growth driver
Z– Zyprexa
– Forteo
– Cymbalta
6Investment Community Meeting June 30, 2011
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1 In Canada Cymbalta is approved for chronic low back pain (or CLBP)2 In Mexico and Brazil Cymbalta is approved for the management of chronic pain
Cymbalta Accelerates GrowthInitial uptake is strong for chronic musculoskeletal painp g p
• Cymbalta SOM growth of1.19%, as
th t d d t f ll 4 4%NTB SOM Branded Agents
other promoted products fall 4.4%
• Chronic Musculoskeletal pain
launch drives recent growth 8%
10%
g
• The MDD+CP market grew 5.3% (TRx MAT, as of March ‘11)
– 70% - 85% of adults experience
low back pain at some time4%
6%
low back pain at some time
o Estimated that 2% - 10% go on to
experience chronic low back pain
– 27 million adults are affected by 0%
2%
27 million adults are affected by
osteoarthritis in the U.S. Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11
LEXAPRO CYMBALTA LYRICA PRISTIQ SAVELLA
7Investment Community Meeting June 30, 2011
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• Source: IMS Padds monthly and weekly data• Other Promoted Products include Lexapro, Pristiq, Lyrica, Savella, Ultram ER, Celebrex• NTB – new-to-brand
Sustained Cialis PerformanceGlobal leadership in near-termGlobal leadership in near term
44%
46%
42%
44%
40%
US
D S
OM
36%
38%
S IMS MIDAS
34%May-09 Jul-09 Sep-09 Nov-09 Jan-10 Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11
Cialis Portf. Cialis OD Viagra
8Investment Community Meeting June 30, 2011
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• Source: IMS MIDAS• WW= Australia, Austria, Belgium, Brazil, Canada, Czech Rep., Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Mexico,
Poland, Portugal, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UK, Venezuela, US (28 countries)
• Cialis Portf. = OD (On-demand) + OaD (Once-a-day)
Cialis – New OpportunitiesOnce-a-day and potentially BPH differentiate brandOnce a day and potentially BPH differentiate brand
• In the U.S. & Major Europe:– 50% of men with ED have BPH
U.S. & Major Europe
75 million men
have ED
75 million men
have ED
• Opportunity:– New mechanism for BPH
– Possible alternative for men not receiving
benefit from current BPH therapypy
– Global BPH market peaked at $4.2 billion*
in 2009
• Possible Benefits:– Reduces medicines takenReduces medicines taken
– Fewer drug-drug interactions
• Promising data in an active control
study, including a tamsulosin arm
50 million men have BPH
50 million men have BPH
• Next steps:– Submissions planned in Canada in Q311
and Europe in 2012
– FDA action expected by year-end 2011
9Investment Community Meeting June 30, 2011
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Men with both conditions
*Source – GBI Research
Axiron LaunchTestosterone market – $1 billion/year and growing$ /y g g
• Launched to specialists in April 2011
A i i h l FDA d• Axiron is the only FDA-approved testosterone
therapy applied to the underarm
• Regulatory actions expected in select EU countries, g y p
Canada and Australia
10Investment Community Meeting June 30, 2011
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Axiron – Strong Initial Uptake Early uptake with specialists is a leading indicatory p p g
Urologists/Endocrinologists Only Primary Care Physicians
Male Hormone Replacement
Therapy Market
50%
60%
- Urologists/Endocrinologists Only -
NTBRx - SOM
60%
70%
- Primary Care Physicians-
NTBRx - SOM
34%
29%30%
40%
50%
40%
50%
6%
21%
10%
20%
10%
13%
15%
10%
20%
30%
5%
5%0%
3/18/11 4/1/11 4/15/11 4/29/11 5/13/11 5/27/11 6/10/11
ANDRODERM ANDROGEL 1% ANDROGEL 1.62%
10%
7%
6%0%
10%
3/18/11 4/1/11 4/15/11 4/29/11 5/13/11 5/27/11 6/10/11
ANDRODERM ANDROGEL 1% ANDROGEL 1.62%
11Investment Community Meeting June 30, 2011
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• NTB – new-to-brand
• Source – IMS
AXIRION FORTESTA TESTIM AXIRION FORTESTA TESTIM
Japan – Countercyclical Growth 3 drivers of near, medium and long-term growth, g g
• Strong current performance, in Q1:
– ~8% ($248 million) of Bio-Medicines revenues
– Japan Bio-Medicines grew 55% (49% volume growth)
• Near-term growth fueled by products launched
last decade in the U.S. and Europe:last decade in the U.S. and Europe:
– Dynamic growth comes at a good time for Lilly!
• Long lifecycles drive growth until late this decade:
Z l i i h h 2015– Zyprexa exclusivity through 2015
o 2010 revenue of over $400 million
– Cymbalta * exclusivity into 2018
– Forteo exclusivity through 2018
• Regulatory submissions simultaneous with U.S.
and EU for pipeline molecules will drive long-term
12Investment Community Meeting June 30, 2011
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sustainable growth
* In partnership with Shionogi
Lilly Bio-Medicines NME PipelinePriority #1 – Deliver the pipeliney p p
New Chemical Entity (NCE)
New Biotech Entity (NBE)
Line Extensions
• Prioritized investments in Neuroscience & Autoimmune
• Opportunistic investments in Cardiovascular, Urology, Bone, Muscle & Joint
• Significant contributor to Lilly’s Phase 3 NME goals (10 NMEs by 2011)
Effient **ACS Med Mgmt
g y g ( y )
• Significant Phase 3 disclosures starting in 2012
• Expect 50% of revenue to come from biologics by the end of this decade
AMPAagitation in Alz’s
IL-17 MAbRA/Psoriasis
OpRAalcohol depend
JAK1/JAK2*RA
mGlu2 PotCysmigraine prev
NERIdepression
mGlu2/3 proschizophrenia
ACS Med Mgmt
TadalafilBPH/ED
ER betaBPH
CymbaltaPeds
Evacetrapibatherosclerosis
Sclerostin MAbosteoporosis
SARM/Tadalafilerectile dys
CB-2osteoarthritis
SolanezumabAlzheimer’s
BAFF MAbRA/Lupus
p
LiprotamaseEPI
Florbetapirβ-amyloid imaging
/
Phase 2 Phase 3 Reg Review
13Investment Community Meeting June 30, 2011
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* In collaboration with Incyte
** In collaboration with Diiachi Sankyo
Solanezumab Clinical DevelopmentPhase 3 studies enrollment complete – results in 2nd half 2012p
• A-beta antibody:
Designed to bind to the A beta peptide in the blood and the central– Designed to bind to the A-beta peptide in the blood and the central
nervous system, potentially increasing clearance of A-beta from the brain
– Mid-domain antibody binds to soluble A-beta, not deposited A-beta
– Phase 3 trials – EXPEDITION and EXPEDITION-2 – are on-going &
enrollment is complete
• Milestones and Data Disclosures• Milestones and Data Disclosures:
– EXPEDITION and EXPEDITION-2 completion within 1st half of 2012
• Secondary endpoint - evaluation of sub-groups of subjects based on apoE
Solanezumab
(LY2062430)
carrier status, with no stratification of patients or altered doses based on apoE
carrier status
• Secondary endpoint – separate sub-group analyses of mild and moderate
patients
14Investment Community Meeting June 30, 2011
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patients
Psychosis Outcomes with Standard of CareSignificant patient needs remainSignificant patient needs remain
Symptom Control Functioning Side Effects
Percent of Patients Controlled Not
Controlled
Positive Sx
63%
37%25%32%
Controlled 29% 14%
ati
ve S
x
63%
Side Effects
43%
Not Impaired
Not Controlled 38% 19%
71% of patients do not have
Ne
ga
75% of patients have 63% of patients
No Side EffectsModerately Impaired
Severely Impaired
p
their positive or negative
symptoms controlled
75% of patients have
moderate to severe
functional impairment
63% of patients
experience side effects
15Investment Community Meeting June 30, 2011
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Sources: BASES mglu Market Research Q4’08; n=240; Patient Segmentation Q1’08; n=1425
Promising mGlu2/3 Safety Data 6-month safety study – weight change versus SOC
6
y y g g
(kg)
4LY2140023 SOC
p< 001p< 001p<.001
p<.001
p<.001 p<.001p<.001
ge in
Wei
ght
0
2
p=.013p=.001
p<.001
p<.001p<.001
CH
ang
-2
0
1 2 3 4 6 8 12 16 20 24-4
16Investment Community Meeting June 30, 2011
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Week of Treatment• ap-values are from Type 3 sums of squares • Bp-values obtained from Fisher’s exact test
Promising mGlu2/3 Safety Data 6-month safety study – shows a differential profile versus SOC
• Incidence of serious adverse events were comparable between
mGlu2/3 and SOC treatment arms
y y p
mGlu2/3 and SOC treatment arms
• mGlu2/3-treated patients were significantly more likely to
experience the TEAEs of insomnia, vomiting, agitation, and
dyspepsiadyspepsia
• SOC-treated patients reported significantly more akathisia and
weight gain
• SOC was associated with greater increases in score of
extrapyramidal symptoms (Parkinsonism and akathisia) and
levels of prolactinp
• Seizures:– The observed exposure-adjusted seizure-incidence has fallen
considerably – and is starting to approach the rate seen in
17Investment Community Meeting June 30, 2011
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co s de ab y a d s s a g o app oac e a e see
development programs for atypical antipsychotics
Promising mGlu2/3 Genetic Data Pharmacogenetic analysis identifies genetic marker
Id tifi ti f ti15
g y g
• Identification of genetic
association in proof of
concept study
P ti t ith T ll l h
S To
tal S
core
5
0
5
10
• Patients with T allele show
greater acute clinical
response to mGlu2/3 agonist
R lt f 6 th
hang
e in
PAN
S
-20
-15
-10
-5
• Results from a 6-month
safety study are consistent
with these dataLS M
ean
Ch
40
-35
-30
-25
LY A/ALY A/TLY T/T
• PANSS = Positive and Negative Syndrome Scale
LY A/A 32
Week
0 1 2 3 4-40
18Investment Community Meeting June 30, 2011
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• LY A/A = 32
• LY A/T = 29
• LY T/T = 4
• LY = mGlu2/3
mGlu2/3 as Add-on TherapyPotential opportunities and next stepspp p
• Potential Opportunities:
– Preclinical data suggest that mGlu2/3 could have synergistic benefits
for positive and/or negative symptoms of psychosis when combined
with standard atypical antipsychotics
– Add-on to SOC Phase 1b study presented at NCDEU• No serious adverse events reported
• Most common adverse events were nausea, vomiting and headache
• Next Steps:
– Phase 2 trial completion expectations:• Active comparator monotherapy in early 2012• Active comparator monotherapy in early 2012
• Add-on therapy trial in late 2012
– Two Phase 3 trials are planned to be complete by mid-2013
19Investment Community Meeting June 30, 2011
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Unmet Medical Need in DepressionNERI target patientNERI target patient
• Adjunctive therapy market – $8 billion and growing
• HCPs find it easier to
• Phase 3 clinical programs evaluate NERI as an adjunctive
therapy in patients with MDD (partial responders)
1/3 Partial-
1/3 RemittersMADRS score ≤10
just add on than
switch to keep the
gain they’ve achieved
and not risk potential 1/3 Partial-
respondersNERI Target
Patient Decrease from
baseline depression
scales of ≥25% and not
in remission
set back2
• In the STAR*D trial,
after failure of an
SSRI 58% of1/3 Non-
responders
in remission
Decrease from baseline
depression scales of
<25%
SSRI, 58% of
PATIENTS preferred
or considered
adjunctive treatment1
20Investment Community Meeting June 30, 2011
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1 Wisniewiski et al. Am J Psych 2007; 354 :1231-1242,
2 Q4 2009 MDD Marketplace Landscape Research
<25%
NERI – Promising Phase 2 dataStudy data supportive of moving into Phase 3Study data supportive of moving into Phase 3
Monotherapy Adjunctive therapy
MADRS Total Score
Change from Baseline to Week 10 from MMRM Analysis
0
e
0
MADRS Total
Score
QIDS-SR16 Total
Score
Effect Size 0.26 0.36
Baseline 28.9 14.8
-8
-6
-4
-2
ean
Cha
nge
-4
-3
-2
-1
Cha
nge
-14
-12
-10
-8
LS M
e
PlaceboNERI
p<0.001-7
-6
-5
-4
LS M
ean
CSSRI
p=.052
p
-9
-8 NERI + SSRIp=.180
21Investment Community Meeting June 30, 2011
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• Abbreviations: LS=least squares; MADRS=Montgomery-Asberg Depression Rating Scale; MMRM=mixed-model repeated measures; QIDS-
SR16 =16-Item Quick Inventory of Depressive Symptomatology-Self Rated; SSRI Selective Serotonine Reuptake Inhibitor
NERI – Promising Phase 2 dataMonotherapy and adjunctive therapy adverse events in Phase 2
Monotherapy Trials (2 studies)Adjunctive Therapy Trial
Monotherapy and adjunctive therapy adverse events in Phase 2
• The most common TEAEs reported in one
or both studies for NERI in >5% of
patients and greater frequency than
placebo:
• The most common AEs reported in the
LY2216684 group in >5% of patients
and greater frequency than placebo:
– hyperhidrosis, nausea, erectile
– nausea, constipation, dry mouth,
increased heart rate, headache, dizziness,
insomnia, and erectile dysfunction.
• No significant worsening in suicidal ideation
b d i NERI d i h
p
dysfunction, and testicular pain
was observed in NERI-treated patients when
compared with placebo-treated patients in any
of the Phase 2 adult studies
Blood pressure/Pulse
• Statistically significant increases in pulse rate, diastolic blood pressure, and systolic blood
pressure were observed in NERI-treated patients relative to placebo
• Mean increases in systolic and diastolic BP (up to approximately 4 mm Hg) and pulse (up to
approximately 10 bpm) were observed for the NERI-treated group compared with placebo
22Investment Community Meeting June 30, 2011
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pp y p ) g p p p
NERI Next Steps
• Ongoing clinical work:
Next Steps
g g
– Five Phase 3 studies ongoing
• Upcoming milestones:
– Initiate comparator studies in 2012 to support
European & Japanese registrations
– Completion of long-term Phase 2 monotherapyCompletion of long term Phase 2 monotherapy
extension study – likely in second half of 2011
23Investment Community Meeting June 30, 2011
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Autoimmune Market OpportunityTremendous market potentialp
• Committed to research in autoimmunity and inflammation
• Autoimmune disease states - forecasted to be among the largest and
fastest growing markets throughout the decade
$Billion 2010 20202010-2020
CAGR
Rheumatoid Arthritis 17 37 8%Rheumatoid Arthritis 17 37 8%
Psoriasis 5 12 9%
Multiple Sclerosis 8 22 11%Multiple Sclerosis 8 22 11%
Inflammatory Bowel Disease 5 11 8%
Total 35 82 9%
24Investment Community Meeting June 30, 2011
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Total 35 82 9%
Source: IMS
Autoimmune Treatment ParadigmTreatment paradigm will change with new mechanismsp g g
Patient Experience Over Time
Increasing pain, joint swelling, structural damage, deformity and debilitation
Cycling Through Anti-TNFs
Current DMARDs1st
Anti-TNF2 d 3 d
Non Anti-TNF
BiologicCurrent
Treatment
Paradigm
NSAIDs
Steroids
(e.g.,
Humira,
Enbrel,
Remicade)
2nd
Anti-TNF
3rd
Anti-TNF
Biologic
“Salvage
Therapy”(e.g. Rituxan)
Reduced Anti-TNF Cycling is Important to Payers
Possible
Future
Treatment
Paradigm
DMARDs
NSAIDs
Steroids
New Oral
TreatmentJAK1/JAK2
OR
1st Anti-TNF
1st or 2nd Anti- TNF
OR
Anti-IL -17 MAb
OR
Anti BAFF MAb
Non
Anti-TNF
Biologic
“Salvage
Therapy”
y g p y
25Investment Community Meeting June 30, 2011
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~20171 Anti-TNF Anti-BAFF MAb py
(e.g. Rituxan)
anti-BAFF MAbFive Phase 3 trials in RA and lupus are in progress
Monocyte, DC, Activated T
cell, Neutrophil and others• Potential differentiating features:
Five Phase 3 trials in RA and lupus are in progress
cell, Neutrophil and others
S l bl BAFFMembrane-
– BAFF can exist in both a
membrane-bound and soluble
secreted form
Soluble BAFFMembrane
bound BAFF• Three Phase 3 trials ongoing in RA:
– Phase 2 studies supportive of
progressing asset into Phase 3
TACI
BCMABAFF R
progressing asset into Phase 3
• Two Phase 3 trials ongoing in Lupus
TACI BAFF R
B Cell
26Investment Community Meeting June 30, 2011
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TACI = transmembrane activator and Ca modulator and cyclophilin ligand interactor; BCMA = B cell maturation antigen; BAFF R = BAFF
receptor; DC = dendritic cell
anti-BAFF MAb Promising Data in RAPhase 2 data – ACR50/20 methotrexate-inadequate respondersPhase 2 data ACR50/20 methotrexate inadequate responders
ACR20ACR50
80
100
40
50
Placebo (n=36)
1 mg (n=30)
3 mg (n=20)
10 mg (n=15)
30 mg (n=18)
e (
%)
* * * * *
*P≤0.05 vs PB
40
60
20
30
60 mg (n=13)
120 mg (n=24)
on
se
Ra
te
*
0 1 4 8 12 16 20 24
0
20
0 1 4 8 12 16 20 24
0
10
Re
sp
o
0 1 4 8 12 16 20 240 1 4 8 12 16 20 24
Weeks
Injections
(NRI) (NRI)Weeks
27Investment Community Meeting June 30, 2011
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• Significant dose response detected at Week 24 (P=0.059)
• Logistic regression using pre-specified two-sided type I error rate of 0.1 • Significant dose response detected at week 24 (P=0.044)
anti-BAFF MAb Promising Data in RAPhase 2 data – ACR50/20 TNF inadequate respondersPhase 2 data ACR50/20 TNF inadequate responders
ACR20ACR50
80
40
50
Placebo (n=35)
30 mg (n=35)
80 mg (n=28)
Combined 30mg and 80mg (n=63)
(%)
40
60
20
30
40
*
**
**P≤0.05 vs PB
** P≤0.001 vs PB**
nse
Ra
te (
*
**
**
0
20
0
10
20*
Re
sp
on
0 1 3 6 9 12 16
0
0 1 3 6 9 12 16
0
Rescue
therapyInjectionsRescue
therapy
Weeks Weeks
28Investment Community Meeting June 30, 2011
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anti-BAFF MAb Promising Data in RATime course concentrations and ACR20 and ACR50 response
mL)
18
%)
50ACR20 ACR50 LY2127399 Concentration
Time course concentrations and ACR20 and ACR50 responseon
c ( μ
g/m
12
15
der R
ate
(
40
2127
399
c
9
R R
espo
n
20
30
dict
ed L
Y2
3
6
serv
ed A
CR
10
20
0 3 6 9 12 15 18 21
Pred
0
Obs
0
29Investment Community Meeting June 30, 2011
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W eeks Rescue therapyInfusions
anti-BAFF MAb Promising Data in RAPhase 2 – integrated safety data
PBO
(n=104)
All LY
(n=308)
Deaths 0 0
Phase 2 integrated safety data
Deaths 0 0
SAEs (# of patients) 10 (9.6%) 22 (7.1%)
SAEs (events) 12 28
DC due to AE 1 (1.0%) 10 (3.2%)
TEAEs (# of patients) 64 (61.5%) 183 (59.4%)
TEAEs (events) 119 368
TEAEs possibly related 21 (20.2%) 85 (27.6%)
Patients with ≥ 1 TEAE 64 (61 5%) 178 (57 8%)
• Most common treatment-emergent adverse events (TEAE):
– Infections – LY (24.0%) vs. placebo (22.1%)
Patients with ≥ 1 TEAE 64 (61.5%) 178 (57.8%)
( ) p ( )
– Investigations – LY (10.7%) vs. placebo (11.5%)
– Musculoskeletal and connective tissue disorders – LY (10.4%) vs.
placebo (21.2%)
30Investment Community Meeting June 30, 2011
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LY = anti-BAFF MAb; SAE = Serious adverse events; DC = Discontinuance; Infections include infestations; Investigations - includes primarily
changes in laboratory parameters or other diagnostic test results
anti-IL-17 MAbPositive Phase 2 trials in RA and psoriasis
• Phase 2 trials are complete in both RA & psoriasis
Positive Phase 2 trials in RA and psoriasis
– Both studies met their primary objectives
– RA trial was a global study in patients who were either naive to
TNF inhibitors or inadequate responders to TNF inhibitors
– Psoriasis patients had moderate to severe psoriasis
– Phase 2 data from the two studies to be disclosed at appropriate
medical meetings
– Completed regulatory discussions in U.S. and Europe
• Next Steps:
Ph 3 ill b i i 2011 i i i– Phase 3 will begin in 2011 in psoriasis
– Phase 3 planning underway for RA, psoriatic arthritis, ankylosing
spondylitis
31Investment Community Meeting June 30, 2011
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JAK1/JAK2Selective inhibitor
• Phase 2b clinical trial on-going in RA
• LY3009104 (formerly INCB28050) is an
oral selective JAK1/JAK2 inhibitor for
inflammatory and autoimmune diseases
• JAK1/JAK2 has at least a 100 fold
greater potency of inhibition in kinase
assays
• No inhibition of JAK3 at clinically-
relevant doses
• Selectivity of inhibition potentially y p y
differentiates this JAK – allowing for a
different mechanism of actionNat. Rev. Immunol 3:901. 2003.
32Investment Community Meeting June 30, 2011
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JAK1/JAK2Phase 2a – results summary and next steps
• Phase 2a efficacy and safety data support further development
in RA:
y p
in RA:
– Demonstrated rapid and sustained efficacy over the 24-week
treatment period:
• Similar responses seen in biologic-experienced and biologic-naïve patientsp g p g p
• Approximately one-third to one-half of subjects achieved remission after 24
weeks (DASCRP < 2.6)
– Adverse events were predominantly mild to moderate and the
most common events were in the infection category:most common events were in the infection category:
• There were dose-related decreases in mean hemoglobin ranging from
approximately 2% to 8% with minimal difference between weeks 12 and 24
• HDL and LDL increased with a trend for improvement in the HDL to LDL ratio;
CRP decreasedCRP decreased
• Next Steps:
– Dose ranging Phase 2b study targeted to complete early in 2012
33Investment Community Meeting June 30, 2011
Not for promotional use Copyright © 2011 Eli Lilly and Company
g g y g p y
Bio-Medicines
• Lilly Bio-Medicines has prepared for the
challenges ahead:
– With infrastructure reductions and
– Investment into our near and mid-term growth g
drivers – Japan, Cymbalta, Forteo, Effient and
Cialis
F d• Focused on:
– Progressing the pipeline expeditiously to drive
growth 2015 & beyond
– Resolving uncertainty early
– Delivering value that patients need, regulators
can approve and payers will support
34Investment Community Meeting June 30, 2011
Not for promotional use Copyright © 2011 Eli Lilly and Company