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R h Report to the Investment Community Eli Lill y and Company June 30, 2011 1 Investment Community Meeting June 30, 2011 Not for promotional use Copyright © 2011 Eli Lilly and Company

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Page 1: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Page 2: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Page 3: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Page 4: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

• Leverage growth in Japan – a key countercyclical growth driver

* Lilly sells the products listed in other countries and other products in the countries listed

Page 5: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

* In collaboration with Incyte

** In collaboration with Daiichi Sankyo

Page 6: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

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

Page 7: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

• Source: IMS Padds monthly and weekly data• Other Promoted Products include Lexapro, Pristiq, Lyrica, Savella, Ultram ER, Celebrex• NTB – new-to-brand

Page 8: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

• 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)

Page 9: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Men with both conditions

*Source – GBI Research

Page 10: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Page 11: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

• NTB – new-to-brand

• Source – IMS

AXIRION FORTESTA TESTIM AXIRION FORTESTA TESTIM

Page 12: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

sustainable growth

* In partnership with Shionogi

Page 13: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

* In collaboration with Incyte

** In collaboration with Diiachi Sankyo

Page 14: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

patients

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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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Sources: BASES mglu Market Research Q4’08; n=240; Patient Segmentation Q1’08; n=1425

Page 16: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Week of Treatment• ap-values are from Type 3 sums of squares • Bp-values obtained from Fisher’s exact test

Page 17: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

co s de ab y a d s s a g o app oac e a e see

development programs for atypical antipsychotics

Page 18: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

• LY A/A = 32

• LY A/T = 29

• LY T/T = 4

• LY = mGlu2/3

Page 19: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Page 20: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

1 Wisniewiski et al. Am J Psych 2007; 354 :1231-1242,

2 Q4 2009 MDD Marketplace Landscape Research

<25%

Page 21: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

• 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

Page 22: RhReport to the Investment Community Eli Lillyypy and ...files.shareholder.com/.../04_Carmine_BioMedicines.pdf · Adjunctive Therapy Trial Monotherapy Trials (2 studies)

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

Not for promotional use Copyright © 2011 Eli Lilly and Company

pp y p ) g p p p

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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

Not for promotional use Copyright © 2011 Eli Lilly and Company

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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

Not for promotional use Copyright © 2011 Eli Lilly and Company

Total 35 82 9%

Source: IMS

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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

Not for promotional use Copyright © 2011 Eli Lilly and Company

~20171 Anti-TNF Anti-BAFF MAb py

(e.g. Rituxan)

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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

Not for promotional use Copyright © 2011 Eli Lilly and Company

TACI = transmembrane activator and Ca modulator and cyclophilin ligand interactor; BCMA = B cell maturation antigen; BAFF R = BAFF

receptor; DC = dendritic cell

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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)

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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

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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

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W eeks Rescue therapyInfusions

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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%)

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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

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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

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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.

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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

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g g y g p y

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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

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