DNA Discovery Red PPT Template

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Oct 3, 2013 ... research and development; competitive developments; regulatory actions; .... NAD+ is a coenzyme required for many metabolic signaling ...
Eli Lilly and Company Investment Community Meeting October 3, 2013 8:30 a.m. – 12:30 p.m.

Copyright © 2013 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 factors including, but not limited to, 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 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 Commission. The company undertakes no duty to update forward-looking statements.

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Lilly Research Laboratories

Jan M. Lundberg, Ph. D. Executive Vice President, Science and Technology and President, Lilly Research Laboratories

Report to the Investment Community Eli Lilly and Company October 3, 2013 Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Agenda  Deliver on late phase portfolio submissions and approvals  Continue to transform R&D to ensure a sustainable flow of innovative medicines – Timely Valued Medicines to Patients – Boosting our internal efforts with external innovation

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Lilly Mid- to Late-Stage Portfolio Increased ~5x since beginning of 2005 39 Molecules in September 2013 (~50% biologics)

New Chemical Entity

New Biotech Entity * Commercial collaborations

As of September 18, 2013

Florbenazine

Park. Dis. Imaging

mPGES-1 osteoarthritis NOC-1 depression

CGRP MAb migraine prev Myostatin MAb disuse atrophy Blosozumab osteoporosis Gluc-R antag diabetes

7 Molecules in October 2004 (14% biologics) Factor Xa inh thrombosis Enzastaurin glioblastoma Naveglitazar diabetes Prasugrel PCI

Arxxant diab retinopathy Arzoxifene osteoporosis

Phase 2

Phase 3

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Byetta diabetes

Reg Review

p38 MAPK inh cancer FGFR inh cancer

DKK-1 MAb cancer GSK3β inh cancer JAK2 inh cancer Hedgehog antag cancer CDK 4/6 inh cancer

Baricitinib RA Evacetrapib HRVD

PCSK9 MAb c-Met MAb CV disease cancer TGFα/Epireg MAb Chk1 inh CKD cancer TGF-β MAb CXCR4 pept inh CKD cancer MR Antagonist Icrucumab CKD cancer TGF-β R1 inh Olaratumab cancer cancer c-Met inh Cixutumumab cancer cancer

squamous NSCLC

Liprotamase EPI

Phase 2

Phase 3

Reg Review

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

Ixekizumab psoriasis/PsA Tabalumab lupus Edivoxetine depression

Solanezumab Alzheimer’s Basal insulin peglispro Necitumumab

Dulaglutide diabetes Ramucirumab gastric 2nd mono New insulin* glargine product Empagliflozin* diabetes

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Lilly Mid- to Late-Stage Portfolio Numerous data readouts in 2013 and 2014 p38 MAPK inh cancer

FGFR inh cancer

CXCR4 pept inh cancer TGF-β MAb CKD

DKK-1 Mab cancer

Florbenazine

Chk1 inh cancer TGF-β R1 inh cancer c-Met inh cancer JAK2 inh cancer Hedgehog antag cancer CDK 4/6 inh cancer

Park. Dis. Imaging

mPGES-1 osteoarthritis NOC-1 depression

CGRP MAb migraine prev Myostatin MAb disuse atrophy Blosozumab osteoporosis

GSK3β inh cancer

c-Met MAb cancer PCSK9 MAb Icrucumab CV disease cancer TGFα/Epireg mAb Olaratumab CKD cancer MR Antagonist Cixutumumab CKD cancer Gluc-R antag diabetes

Phase 2

Baricitinib RA Evacetrapib HRVD

New Chemical Entity

New Biotech Entity * Commercial collaborations

Solanezumab Alzheimer’s Liprotamase EPI

Ixekizumab psoriasis/PsA Tabalumab lupus Edivoxetine depression Empagliflozin* diabetes

Basal insulin peglispro New insulin* glargine product Dulaglutide diabetes Necitumumab

squamous NSCLC

Ramucirumab gastric 2nd mono

As of September 18, 2013

 Internal data readout and/or advancement expected by the end of 2014 for: – 9 of the 13 assets in Phase 3 or under regulatory review – a majority of the Phase 2 portfolio  4 assets filed for regulatory approval in 2013

Phase 3/ Regulatory review

= Assets that have, or are expected to have, an internal data readout and/or clinical or regulatory advancement during 2013 and 2014 Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Agenda  Deliver on late phase portfolio submissions and approvals  Continue to transform R&D to ensure a sustainable flow of innovative medicines – Timely Valued Medicines to Patients – Boosting our internal efforts with external innovation

Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Timely Value Medicines to Patients (TVM) A patient-centric, data-driven quality approach • Timely: Attractive Remaining Intellectual Property + Data Protection and Order of Market Entry • Satisfying Unmet Medical Needs with Higher Success Rates • Differentiating from Standard of Care and Competition • Generation of Value for Regulators, Payers, Providers, Patients and Lilly

Better disease understanding

Tailoring of medicines

Right therapeutic agents

Robust Phase 2 data

Supported by our Innovation Ecosystem and Information Technology

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Diabetes Impact of complications and co-morbid conditions Lilly Products and Pipeline Agents Offer Potential Benefits Beyond Glucose Lowering

Diabetic Nephropathy

Diabetic Peripheral Neuropathic Pain

TGF-β mAb TGF-a mAb Baricitinib Others

Effient Heart Disease

Evacetrapib PCSK9 mAb

Cymbalta

Peripheral Vascular Disease Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Focus on Core Areas of Cancer Biology

Cancer Angiogenesis

Developmental Pathways

Cancer Signaling and Cell Cycle

Tumor Immunotherapy

Cancer Metabolism

Epigenetics

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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NAMPT A novel cancer metabolism target

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 NAMPT: a rate-limiting enzyme for an essential salvage pathway for production of NAD+ • NAD+ is a coenzyme required for many metabolic signaling reactions 1

NAMPT = Nicotinamide phosphoribosyltransferase; NAPRT = nicotinic acid phosphoribosyltransferase; NAD = Nicotinamide adenine dinucleotide Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Alzheimer’s Disease Research Strategy

Highest priority: Win at Amyloid

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Target Tau as a second approach to disease modification

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

Identify and develop targets for symptomatic relief

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Tau PET Images Increased tracer uptake with disease progression Increasing Disease Severity Healthy

MCI MMSE=26

Mild AD MMSE=21

Severe AD MMSE=7

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R=-0.854

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SUVr (Target/Cerebellum)

SUVr = standardized uptake value ratio; MMSE = mini mental status exam Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Cancer Tailoring Continuum

Pan-RAF, TGF-β R1, CDK 4/6, and c-Met Ab Pan-RAF

TGF-β R1

CDK4/6

c-Met Antibody

Melanoma, Lung, and Hematologic tumors

HCC

Breast

NSCLC

Control

Pre-dose

MET(-)

TGF-β inh.

Post-dose

MET(+)

p-SMAD2/3

p-Rb in skin

Met IHC companion diagnostic

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Expanding Therapeutic Innovation Large and Small Molecule Strategies and Technologies

Tissue-specific Therapeutics

Large Protein-Peptide Fusion Antibody-Drug Conjugates

Bi-specific Antibodies Fragment Derived Small Molecules

Multi-functional Proteins Monoclonal Antibodies

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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N3pG A-beta Antibody

6500

4000

3p G N

m ab

C B ap in eu zu

1 DeMattos

Su rr og at e

1500

on tr ol

Non-Selective N-Terminal Aβ Antibody

9000

og at e

-30%, p = 0.0066 -53%, p < 0.001

Su rr

N3pG Antibody specific for insoluble amyloid

Limited Microhemorrhage Liability

Removal of Existing Plaque

Number of Meningeal H emosiderin Positive Cells

Binds only to deposited Aβ

et al., A Plaque-Specific Antibody Clears Existing b-amyloid Plaques in Alzheimer’s Disease Mice, Neuron (2012).

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October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Blocking the Spread of Tau Pathology

*

* from transgenic mice Not for promotional use

October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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mPGES-1 Inhibitor Suppresses prostaglandin E2 but not prostacyclin LY potently inhibits inducible PGE2 synthesis

LY does not suppress prostacyclin synthesis

Data presented as geometric mean and 90% confidence interval. *P