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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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Oncology

Sue Mahony, Ph. D. Executive Vice President and President, Lilly Oncology

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


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Lilly Oncology Priorities

Grow our existing products


Deliver our Phase 3 pipeline

Progress our early and mid phase pipeline


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Cancer Large and growing global need • Cancer incidence1 – 14.9 million in 2015 growing to 21.4 million by 2030

• Cancer market2

Tailoring Novel Combinations

– $64 billion in 2012 growing to $120 billion in 2020

Chronic Care Aging

1 2

American Cancer Society (projected incidence) IMS Health Not for promotional use


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Alimta Growing a mature brand year after year Alimta 1st Line Nonsquamous NSCLC

WW Alimta Revenue since Launch U.S. Approval Continuation Maintenance

3,000

2,500

75%

U.S. Approval: Switch Maintenance

60%

2,000 Share of Market

USD, millions

U.S. Approval: 1st-Line NSCLC

1,500

1,000

45%

30%

U.S. Approval: Mesothelioma U.S. Approval: 2nd-Line NSCLC

15%

500

0

0% 2004

2005

2006

2007

Source: Internal sales data, data on file

2008

2009

2010

2011

2012

 Alimta WW sales grew 5% in 2012 with volume increasing 11%  Alimta WW sales in 1H2013 ($1.3B) grew 2% with volume increasing 6%


France UK

Germany USA

Italy Japan

Spain

Source: EU M5: GfK/Lilly NSCLC Share Tracking; U.S.: IntrinsiQ; Japan: Ipsos Health care patient monitor data


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Alimta Patent-Based Exclusivity Compound-Based Exclusivity

Vitamin Dosage Regimen Patents

 Patent expiration: May 2022 with pediatric extension U.S.

 Patent expiration: January 2017 with pediatric extension

 Indianapolis district court trial against Teva/APP/Pliva/Barr occurred in August 2013  Accord/Apotex trial scheduled for July 2014  Accord petition for Inter Partes Review dismissed by U.S. PTO

 Patent expiration: June 2021

Europe

 Patent expiration: December 2015 (M5)


 Validity – Lilly prevailed over an opposition filed by Teva at the EPO – Teva appealed and Actavis Deutschland GmbH & Co. KG intervened in the appeal – No hearing date set for the appeal  Infringement – UK: Declaration of non-infringement filed by Actavis Group hf for the M5 countries, trial scheduled April 2014 – Germany: Infringement action by Lilly against Actavis Group PTC ehf and Actavis Deutschland GmbH &Co., German patent only, trial scheduled March 2014 October 2013 Investment Community Meeting Copyright © 2013 Eli Lilly and Company

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Alimta Maintenance A growth opportunity

Alimta SOM in nonsquamous NSCLC

1Data

% of 1st-line patients receiving maintenance therapy2

1st-Line1

Maintenance1

France

62%

74%

57%

Germany

45%

62%

36%

Italy

49%

72%

21%

Spain

47%

72%

46%

UK

58%

72%

21%

U.S.

39%

79%

60%

Japan

73%

77%

43%

• Market research indicates that physicians tend to overstate the percent of patients receiving maintenance therapy – For example, U.S. audit data suggests only ~20% of eligible patients receive maintenance therapy vs. 60% based upon physician responses

from Q2 2013 research with physicians (Q2 2013)

2Market



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#1 Grow our Grow our existing existing products products





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Lilly Oncology Expanding our near-term thoracic portfolio

2nd-Line

1st-Line

Nonsquamous

Squamous

Necitumumab

Alimta

Mutations in EGFR and ALK

(BLA submission expected by end of 2014)

Ramucirumab = current registration efforts



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Necitumumab SQUIRE trial design

Arm A  Necitumumab + gemcitabine + cisplatin

PR necitumumab PD CR SD

– 800 mg I.V. necitumumab, days 1 and 8 – 1250 mg/m2 gemcitabine, days 1 and 8

 Stage IV,

squamous NSCLC

 1,093 patients  ECOG PS 0-2

R A N D O M I Z E

PD

– 75 mg/m2 cisplatin, day 1

3 week cycles maximum of 6 cycles

Arm B  gemcitabine + cisplatin – 1250

mg/m2

PD

gemcitabine, days 1 and 8

– 75 mg/m2 cisplatin, day 1



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Necitumumab

Potential target population: stage IV, squamous NSCLC

NSCLC

WW incidence1: 1.6 million Annual deaths1: 1.4 million

 High unmet need with limited

innovation in last two decades

Nonsquamous (~70%)

2

Squamous (~30%)

2

 No biologic agents approved in

squamous NSCLC

 Most common 1st-line regimen is

1st-line Stage IV squamous NSCLC Major Markets: ~70,000 drug-treated patients2

platinum-based with either gemcitabine or paclitaxel

1American 2Kantar

Cancer Society, Global Cancer facts and figures, 2nd Edition Health Cancer Mpact 2013 (US, EU M5 and Japan)



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Ramucirumab

Advanced gastric cancer  Two positive Phase 3 trials for ramucirumab in advanced gastric cancer with improved overall survival and prolonged progression-free survival  REGARD – ramucirumab as a single agent vs. best supportive care  RAINBOW – ramucirumab in combination with paclitaxel vs. paclitaxel – Detailed results expected at a medical meeting in 1H 2014

 U.S. and EU submissions for REGARD complete  Intend to submit application to regulatory authorities based upon RAINBOW results Not for promotional use


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Ramucirumab

Potential as a single agent or in combination for advanced gastric cancer Patient with advanced gastric cancer – Refractory disease or progression

after initial chemotherapy

Chemotherapy eligible? no

Ramucirumab single-agent treatment regimen per REGARD Not for promotional use

yes

Ramucirumab + paclitaxel treatment regimen per RAINBOW


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Ramucirumab

Potential target population: advanced gastric cancer

Gastric Cancer

WW incidence1: 1.0 million Annual deaths1: 0.7 million

 No approved therapies in U.S. or

Europe

HER2(78%)

2

HER2+ (22%) 2

 No standard of care  Variety of therapies used including

taxanes, 5-FU, irinotecan

 20-25% patients do not receive

Advanced gastric cancer Major Markets: ~40,000 drug-treated patients3

treatment

1American

Cancer Society, Global Cancer facts and figures, 2nd Edition Health Treatment Architecture, US (June 2013) and EU (May 2013) 3Kantar Health Cancer Mpact 2013 (US, EU M5 and Japan) 2Kantar



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Ramucirumab Ongoing phase 3 trials

REACH (HCC)  2nd-line

REVEL (lung)  2nd-line

 post sorafenib

 Non-squamous or squamous histology

RAISE (mCRC)  2nd-line  FOLFOX/bevacizumab

resistant

 N = 544

 N = 1,242

 N = 1,050

 BSC +/- RAM

 Docetaxel +/- RAM

 FOLFIRI +/- RAM

 q 2 weeks, 8 mg/kg



Enrollment completed and overall survival data expected in 2014

HCC = hepatocellular carcinoma; mCRC = metastatic colorectal carcinoma; BSC = best supportive care; RAM = ramucirumab Not for promotional use


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Ramucirumab Phase 3 Program Designed to evaluate improvement in OS in a number of settings OVERALL SURVIVAL

IN COMBINATION WITH OTHER THERAPIES

AS A SINGLE AGENT

 REGARD (mGC) REACH (HCC)

WHERE OTHER ANTIANGIOGENIC AGENTS ARE NOT APPROVED

RAINBOW (mGC)

 REGARD (mGC)

RAISE (mCRC)



RAINBOW (mGC)

REACH (HCC)

ROSE (mBC) REVEL (NSCLC)



ROSE (mBC)1

RAISE (mCRC) 1 bevacizumab

is not approved in the U.S. for breast cancer


UPON PROGRESSION AFTER PRIOR TREATMENT WITH AN ANTI-ANGIOGENIC


 - trial met primary endpoint  - trial did not meet primary endpoint 18

Ramucirumab

Addressing tumors with high unmet need

1 2

HCC

Gastric

NSCLC2

Colorectal

WW incidence 20081

748,300

989,600

1,600,000

1,200,000

Mortality cases 20081

695,500

738,000

1,378,400

608,700

American Cancer Society, Global Cancer facts and figures, 2nd Edition Includes all non-small cell lung cancers independent of histology

Age-Adjusted 1-year Survival Rate for Patients Diagnosed at Advanced Stage3 60% 49%

50% 40%

33%

30% 21% 20%

13%

14%

HCC

Pancreatic

24%

10% 0%

3

Gastric

Lung

Kidney and Renal Pelvis

Colorectal

2000-2010 SEER



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Progressing a High-Value Pipeline June 2011 to present Progression to Phase 1 4 New Molecular Entities PI3/mTOR inh Notch inh TGFβR2 MAb CSF1R MAb

Removed from Phase 1 6 New Molecular Entities CXCR4 MAb GP75 MAb P70 S6 inh Notch inh Gem prodrug RON MAb

Progression to Phase 2 11 New Molecular Entities CDK 4/6 inh c-Met MAb c-Met inh Chk1 inh Myostatin MAb Hedgehog antag Tabalumab JAK2 inh p38 MAPK inh FGFR inh CXCR4 pept inh

Removed from Phase 2 5 New Molecular Entities Survivin ASO Eg5 inh p38 MAPK inh Chk1 inh eIF-4E ASO

Ongoing Phase 3 6 Phase 3 Trials Ramucirumab 2ndst -line gastric combo 1nd-line mBC 2 -line HCC 2nd-line NSCLC 2nd-line mCRC Necitumumab 1st-line squamous NSCLC

Ongoing Registration 1 New Molecular Entity: U.S. and EU submissions  Ramucirumab in advanced gastric as a single agent

Removed from Phase 3 2 New Molecular Entities Enzastaurin Tasisulam

 - trial met primary endpoint  - trial did not meet primary endpoint Not for promotional use


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Prioritizing a High-Value Pipeline

Prioritized Assets

As of June 2011 (n = 34)


As of today

R&D Spend

(n = 23)


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Select Priority Assets CDK 4/6 Inhibitor  Continuous dosing;

crosses blood-brain barrier1

 Single-agent clinical

activity in breast, NSCLC, glioblastoma, melanoma and other tumors

c-Met Antibody  c-MET antibody with dual

mechanism: inhibition of tumor growth by blocking HGF and degrading MET receptor

TGF-β R1  Potential first-in-class

molecule; blocks TGF-β signaling and modulates immune system

Development Status  Ongoing tumor-specific expansions in NSCLC, glioblastoma, breast, colorectal, and melanoma  Other Phase 2 and Phase 3 studies currently being planned

 Phase 1 tumor-specific expansions include NSCLC, prostate cancer, RCC, uveal melanoma, and HCC cohorts  Phase 2 studies initiating in 1st and 2nd-line NSCLC  Companion diagnostic in development with Dako

1Based

 Phase 1 study complete  Phase 2 studies initiated: – hepatocellular carcinoma: 2nd-line – glioblastoma multiforme: 1st-line and 2nd-line – pancreatic cancer: 1stline in combination with gemcitabine

upon cerebrospinal fluid and plasma samples from patients with brain tumors or brain metastases



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Lilly Oncology Priorities … and Vision




Our vision: Change the world of cancer care Not for promotional use


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