eli lilly, bio-medicines rob brown for personal use only
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1Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Eli Lilly, Bio-MedicinesRob Brown
Chief Marketing Officer, Eli Lilly and CompanySenior Vice President, Eli Lilly Bio-Medicines
Report to Acrux Investment Community
Eli Lilly and CompanyAugust 23, 2011
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2Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Safe Harbor Provision
This presentation contains forward-looking statements that are based onmanagement’s current expectations, but actual results may differ materially dueto various factors. The company’s results may be affected by such factors asthe risks and uncertainties in pharmaceutical research and development;competitive developments; regulatory actions; litigation and investigations;business development transactions; economic conditions; and change in lawsand regulations, including health care reform. For additional information aboutthe factors that affect the company’s business, please see the company’s latestForms 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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3Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Axiron• Lilly is committed to men’s health and is well
positioned to appropriately support the global launch and growth of Axiron
• Cialis and Axiron are synergistic products for men’s health sales forces around the globe to promote
• The testosterone therapy market is over $1.5 billion US dollars and grew at approximately 26% in 2010
• Axiron is in a unique position to take advantage of the growing testosterone therapy market in the US
• Strong launch performance in the US marketFor
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4Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
U.S. & Puerto Rico,
$1,937
Europe, $828
Japan, $248CA, AU, NZ,
$150
Zyprexa, $1,153
Cymbalta, $873
Other, $657
Cialis, $343Evista, $250Forteo, $197
BioMedicines
54%Diabetes
16%
Oncology15%
Emerging Markets
10%
Animal Health
5%
Bio-Medicines Business PerformanceStrong execution
• 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 • Leverage growth in Japan – a key countercyclical growth driver
Q1 Lilly Bio-Medicines Revenue*100% = $3.2 billion USD
Q1 Total Lilly Revenue100% = $5.8 billion USD
* Lilly sells the products listed in other countries and other products in the countries listed
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5Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Lilly Bio-Medicines NME Pipeline(as of June 16, 2011)
Priority #1 – Deliver the pipelineNew Chemical Entity (NCE)New Biotech Entity (NBE)
* In collaboration with Incyte** In collaboration with Daiichi Sankyo*** In the US only
Evacetrapibatherosclerosis
AMPAagitation in Alz’s
Sclerostin MAbosteoporosis
IL-17 MAbRA/Psoriasis
OpRAalcohol depend
JAK1/JAK2*RA
SARM/Tadalafilerectile dys
mGlu2 PotCysmigraine prev
CB-2osteoarthritis
SolanezumabAlzheimer’sBAFF MAbRA/Lupus
NERIdepression
mGlu2/3 proschizophrenia
LiprotamaseEPI
Florbetapir-amyloid imaging
Prasugral **ACS Med Mgmt
Tadalafil ***BPH/ED
ER betaBPH
DuloxetinePeds
• 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)• Expect significant Phase 3 disclosures starting in 2012• Expect 50% of revenue to come from biologics by the end of this decade
Phase 2 Phase 3 Reg Review
Line Extensions
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6Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Lilly is committed to Men’s Health
Note (s): Axiron is not approved in Australia.
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7Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
US Market UnderstandingPerformance Measures
• TRx = Total Prescriptions = NPA measure representing the total (new + refill) prescriptions dispensed by the pharmacist.
• NRx = New Prescriptions = NPA measure representing the new prescriptions dispensed by the pharmacist .
• NTBRx = New To Brand = The volume of Rxs that are associated with first-time use of a product. It reports prescriptions for patients that are starting therapy with a product for the first time within 12 month. More specifically, it includes:
– New to Therapy: This is the first prescription dispensed for the patient during a 12 month period.
– Switch to Therapy: The patient is new to the product but has previously taken at least one other product in the therapy class during the past 12 months.
Note (s): NPA = National Prescription Audit. It’s standardized (syndicated) national prescription data. No vouchers are removed, and scripts do not need to be normalized.
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8Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
US Market UnderstandingPayer Environment
Note: Most payers wait about 9-12 months post launch to review & add new products.For
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9Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Testosterone Market Topical therapy makes up the majority of global market
Global Market$1.5 billion USD
Male Hormone Replacement Therapy Market
2010
US Market$1.3 billion USD
OUS Market$0.2 billion USD
• 85% of market is in the US• In 2001, US testosterone sales were approximately $0.2 billion USD
Source: IMS data
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10Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Testosterone Market is GrowingGlobal 5 year CAGR = 17.4%
US Market 2005 - 2010
• 5 Year CAGR = 19.3%• Topical therapies driving market growth • Androgel has majority of $ SOM
OUS Market2005 - 2010
• 5 Year CAGR = 8.8%• Long term injections and topical therapies driving
market growth
Source: IMS data Note (s): The products referred to have regulatory approval in the US and some are not approved in Australia.
-
50,000
100,000
150,000
200,000
250,000
2005 2006 2007 2008 2009 2010
USD
GEL ORAL PATCH INJ: LONG INJ: SHORT
12%
1%14%10%
20%
-
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
2005 2006 2007 2008 2009 2010
USD
ANDROGEL TESTIM ANDRODERM INJECTIONS OTHER
1520%
29%
29%
21%
Male Hormone Replacement Therapy Market
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11Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Market Changing Rapidly3 new products in US testosterone market in short period
• 3 new products launched in US
• Fortesta (Feb 2011) • Axiron (April 2011)• Androgel 1.62% (May 2011)
• The low testosterone market is rapidly changing…
….for Patients… for Providers… for Payers
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12Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
US Axiron LaunchTestosterone market - $1.5 billion USD/year and growing
• Launched to US specialists in April 2011 and primary care in June 2011 with a strategy focusing on:
• Articulating the right patient to health care providers
• Removing barriers to trial• Patient support
• Market research with US health care providers suggests our launch approach is successful
• Regulatory actions expected in select EU countries, Canada and AustraliaF
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13Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Axiron – Strong Initial US Uptake Early uptake with specialists is a leading indicator
US Male Hormone Replacement Therapy Market
Source: IMS dataNote (s):* The products referred to have regulatory approval in the US and some are not approved in Australia.* NTB – new-to-brand.
28.6%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
Urologists / EndocrinologistsNTBRx - SOM (%)
ANDRODERM ANDROGEL - TOTAL ANDROGEL 1%
ANDROGEL 1.62% AXIRON FORTESTA
TESTIM
21.1%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Primary Care PhysiciansNTBRx - SOM (%)
ANDRODERM ANDROGEL - TOTAL ANDROGEL 1%
ANDROGEL 1.62% AXIRON FORTESTA
TESTIMFor
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14Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
US Axiron Business = New+SwitchThe majority of the business is new patients
US Male Hormone Replacement Therapy Market
Source: IMS dataNote (s):* The products referred to have regulatory approval in the US and some are not approved in Australia.
1,954
0
500
1,000
1,500
2,000
2,500
# of
pre
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tions
Switch to Axiron fromTESTIM
Switch to Axiron fromINJECTABLES
Switch to Axiron fromFORTESTA
Switch to Axiron fromBULKTESTOSTERONESwitch to Axiron fromANDROGEL 1%
Switch to Axiron fromANDROGEL 1.62%
Switch to Axiron fromANDRODERM
Switch to Axiron fromALL OTHER TOPICALS
Switch to Axiron fromALL ORALS
New Therapy Starts
Source of Axiron NBTRx
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15Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
Market TRx / NRx SOM by SpecialtyEarly uptake with specialists is a leading indicator
Source: IMS data
US Male Hormone Replacement Therapy Market
5.4%
8.4%
4.8%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
8.0%
9.0%
Axiron TRx SOM by Specialty (%)
PCP URO/ENDO ALL OTHER
8.3%
11.4%
6.4%
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
Axiron NRx SOM by Specialty (%)
PCP URO/ENDO ALL OTHER
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16Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
US Market TRx SOM by ProductAxiron = 6.1%
US Male Hormone Replacement Therapy Market
Source: IMS dataNote (s):* The products referred to have regulatory approval in the US and some are not approved in Australia.
65.9%
58.9%
6.1%
19.9%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
TRx SOM by Product (%)
ANDRODERM ANDROGEL TOTAL ANDROGEL 1.62% ANDROGEL 1%
AXIRON FORTESTA TESTIMFor
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17Acrux Investment Community Presentation, August 23, 2011.Not for promotional use. Copyright © 2011 Eli Lilly and Company
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