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.
Not for promotional use
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
Not for promotional use
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
Not for promotional use
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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1
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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
1
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
Not for promotional use
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
Not for promotional use
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).
Not for promotional use
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