Progressing Towards A Globally Competitive R&D-Oriented

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30th Annual J.P. Morgan Healthcare Conference January 9, 2012 Dainippon Sumitomo Pharma (“DSP”) Masayo Tada President and CEO Progressing Towards A Globally Competitive R&D-Oriented Pharmaceutical Company

Transcript of Progressing Towards A Globally Competitive R&D-Oriented

Page 1: Progressing Towards A Globally Competitive R&D-Oriented

30th Annual J.P. Morgan Healthcare ConferenceJanuary 9, 2012

Dainippon Sumitomo Pharma(“DSP”)

Masayo TadaPresident and CEO

Progressing Towards A Globally Competitive R&D-Oriented Pharmaceutical Company

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Disclaimer Regarding Forward-looking Statements

The statements made in this presentation material are forward-looking statements based on management’s assumptions and beliefs in light of information available up to the day of announcement, and involve both known and unknown risks and uncertainties. Actual financial results may differ materially from those presented in this document, being dependent on a number of factors. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

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Agenda

1. Company Overview

2. North America Business & LATUDA

3. Japanese Business

4. Product Pipeline

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Agenda

1. Company Overview

2. North America Business & LATUDA

3. Japanese Business

4. Product Pipeline

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Total Revenue : US$ Bil. 4.3(Consolidated : Mar 31, 2010)

3220 4320

Created from merger of Dainippon Pharmaceutical and Sumitomo Pharmaceuticals in Oct 2005No. of employees: 8,026 (consolidated, as of Sep 30, 2011)Headquartered in Osaka, JapanMajor Subsidiaries in U.S. (Sunovion Pharmaceuticals Inc.) and China

1-1. Profile of DSP

*: Animal Health Care, Food additives, etc

Pharmaceuticals

Non-Pharmaceuticals *

88%

12%

Head Office (Osaka)

Exchange Rate:

FY2010: ¥87.8 per 1US$

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1-2. DSP’s Path Toward Our Vision

Globally Competitive

R&D-Oriented Pharmaceutical

Company

• Acquisition of Sunovion• NDA of LATUDA• Launch of 5 products in Japan

• Launch of LATUDA in the U.S.• In-licensing of 4 compounds2005

2022

2007

2010

2015

1st

3rd

2nd

Global expansion Strategic Objectives Reinforce Japan earning base

Enrich R&D pipeline

MTBP

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(by Regions, Pharma Business)

4.2

3.8

FY2010Result

FY2014 Target

1-3. Our Revenue Goal in FY2014

Expand US Revenue

primarily from LATUDA’s

Growth

Expand US Revenue

primarily from LATUDA’s

Growth

JAPAN

N.AMERICA

CHINA

Exchange Rate:

FY2010: ¥87.8 per 1US$

FY2014: ¥90.0 - do -

Our Mid-term

Business Plan

(2010 – 2014)

Maintain almost flat revenue trend,

despite many challenges

Maintain almost flat revenue trend,

despite many challenges

(US$Bil.)

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Agenda

1. Company Profile

2. North America Business & LATUDA

3. Japanese Business

4. Product Pipeline

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Established in Jan 1984 as Sepracor Inc., and acquired by DSP in Oct 2009

No. of Employees:2,592

Sales Reps:1,530 (As of Sep 30, 2011)

Headquartered in Marlborough, MA

Net Sales:US$Mil. 1,348 (FY2011 Forecast)US$Mil. 1,340 (FY2010)

Main Products:Lunesta® (Insomnia), Xopenex® I.S., Xopenex HFA® (Asthma), Brovana® (COPD), Omnaris® (Allergic Rhinitis), Alvesco® (Asthma), Latuda® (Schizophrenia)

2-1. Profile of Sunovion

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FY20100

1,000

Revenues (US$ Mil.)

LATUDA®LATUDA®

with LATUDA®, Our Growth Driver2-2. Expand North America Business

MarketedLUNESTA®

XOPENEX® I.S.XOPENEX HFA®

BROVANA®

OMNARIS®

ALVESCO®

Other new productsCiclesonide HFASTEDESATM

MarketedLUNESTA®

XOPENEX® I.S.XOPENEX HFA®

BROVANA®

OMNARIS®

ALVESCO®

Other new productsCiclesonide HFASTEDESATMFY2014

Target

1,340

2,000

Exchange Rate:

FY2010: ¥87.8 per 1US$

FY2014: ¥90.0 - do -

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Launched in Feb. 2011 in U.S. for Schizophrenia

Launched in Feb. 2011 in U.S. for Schizophrenia

-1st atypical antipsychotic to receive a first-cycle US FDA approval

-- Clinical studies to date demonstrate LATUDA’s significantly higher efficacy for Schizophrenia vs. placebo

-- Favorable weight gain and metabolic profile

-- No QTc warning on label

2-3. Profile of LATUDA®

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26%

34%11%

29%

Bipolar,19 million TRxs

Schizophrenia,14.5 million TRxs

Other*,15.7 million TRxs

MDD,6.3 millionTRxs

*Other includes:- Other Psychoses/ Psychotic

Depression- Anxiety States- Conduct Disorders

& Future Opportunity of LATUDA®

Source: IMS, IMS NDTI 2010, and WK PHAST weekly report-rolling 52 weeks

Bipolar,19

Schizophrenia,14.5

Others*,15.7

MDD,6.3

2-4. Atypical Antipsychotic Market (by Indications)

(Mil. TRxs)Total Market:

US$16 Bil(2010)

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2-5. Future Prospective for LATUDA®

FY2011Forecast

FY2014Target

0

500

Sales Forecast(Mil. US$)

Bipolar disorder (depression)Bipolar disorder (depression)

Bipolar maintenanceBipolar maintenance

MDD with mixed featuresMDD with mixed features

Other studies under considerationOther studies under consideration

sNDA planned in 2012

Exchange Rate: FY2011:

¥80.0 per 1US$FY2014:

¥90.0 - do -

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2-6. Global Expansion of LATUDA®

JapanSchizophreniaNew Phase III study under preparation

EuropeSchizophrenia/

Bipolar disorder

Co-development with Takeda

Pharmaceutical(Phase III)

ChinaSchizophreniaIND submitted(September

2011)

CanadaSchizophreniaNDS submitted

(June 2011)

U.S.(Launched)

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2-7. Pipeline of U.S. Pharma Business

Overactive bladderafacifenacinfumarateSMP-986

Neuropathic Pain MDD

TBDSEP-228432

Alzheimer’s diseaseType 2 diabetes

TBDDSP-8658

MDDTBDDSP-1053

(New formulation) Allergic rhinitisciclesonideCiclesonide HFA

Nasal Aerosol

NDAsubmittedPhase IIIPhase IIPhase I

Epilepsy-Adjunct

Proposed indication

eslicarbazepineacetate

Generic name

STEDESATM

Brand name/ Product code

Product Pipeline for U.S. Excluding LATUDA® (as of December 1, 2011)

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Agenda

1. Company Profile

2. North America Business & LATUDA

3. Japan Business

4. Product Pipeline

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0 200 400 600 800 1000

3-1. Japanese Pharma Market & Our Efforts-1

Copyright 2011 IMS Health. All rights reserved. Estimated Based on IMS World Review Executive 2010-2011 Reprinted with permission.

Japan 11%

Total: 601

861

Japanese market is still growing, and key to our solid earning base

N. America 43%

EuropeMain 5 20%

Others 26%

Japan 10%

N. America 39%

EuropeMain 5 17%

Others 34%

2005

2010

US$ (Bil.)

6886

Address Challenges* & Achieve Robust Sales Base

Increase Revenue from New Products

*NHI Price Cut, Increasing Generic Threat, etc.

Still Growing

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180 179 175 172179

FY2006 FY2008 FY2011Forecast

FY2009 FY2010FY2007

178

AmBisomeⓇ ReplagalⓇ LONASENⓇ

AVAPROⓇ

TRERIEFⓇ

MIRIPLAⓇ

METGLUCOⓇ SUREPOSTⓇ

NHI Price Cut NHI Price Cut &

Amlodipine generic NHI Price Cut

Marketed

NewProducts

100

0

(Bil. Yen)

Sales

8 launches in 6 years

3-2. Japanese Pharma Market & Our Efforts-2- Contribution of Our New Products -

DSP’s Sales

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3-3. Strategy for Japan Pharma Business

Schizophrenialurasidone hydrochlorideLATUDA

NDAsubmittedPhase IIIPhase IIPhase I

Diabetic neuropathy

Hypertension /Combination agent

Proposed indication

ranirestat

amlodipinebesilate/irbesartan

Generic name

AS-3201

DSP-8153

Brand name/ Product code

NDA submitted in Nov. 2011

New P III study under preparation

PIII study started

Product Pipeline for Japan (as of December 1, 2011)

Other 9 products (including new indications) are under development for Japan

Also striving to in-licensing late-stage compounds

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Agenda

1. Company Profile

2. North America Business & LATUDA

3. Japanese Business

4. Product Pipeline

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4-1. Product Pipeline

Therapeutic Strategy – Core Research Areas

R&D professionals: approx. 1,500- 1,040 (Japan), 450 (U.S.), 20 (China)R&D costs: approx. US$ Mil. 740 (FY2011 forecast)R&D facilities: Osaka (Japan), Massachusetts, New Jersey, London, Suzhou (China)

Current Status & Our Strategy

2nd OncologyImmunology

1stCNS

Current Status

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4-2. DSP’s Strong Expertise in CNS

TRELIEF® (Parkinson's Disease)TRELIEF® (Parkinson's Disease)LONASEN® (Schizophrenia)LONASEN® (Schizophrenia)

- Our Strong Track Record ultimately led to LATUDA -

MYSTAN® (Epilepsy)MYSTAN® (Epilepsy)

LULLAN® (Schizophrenia)LULLAN® (Schizophrenia)

SEDIEL® (Anxiety)SEDIEL® (Anxiety)

DOPS® (Parkinson's Disease)DOPS® (Parkinson's Disease)

SERENACE® (Schizophrenia)SERENACE® (Schizophrenia)

EXEGLAN® (Epilepsy)EXEGLAN® (Epilepsy)

Originally launched by predecessors:

Dainippon Pharmaceutical

Sumitomo Pharmaceuticals

LATUDA®

(Schizophrenia)LATUDA®

(Schizophrenia)

LUNESTA®

(Insomnia)LUNESTA®

(Insomnia)

Expertise in R&D & Commercialization

Our Major Marketed Products

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US/Europe, etc.(New indication) Bipolar disorder (depression)

USAlzheimer’s diseaseTBDDSP-8658

US/Europe, etc.(New indication) Bipolar disorder (maintenance)

JapanSchizophrenia

US(Change of maximum dose) Schizophrenia: 160mg daily

LATUDA(SM-13496) : Co-development with Takeda Pharmaceutical in Europe (Phase III Study : Schizophrenia , Bipolar disorder )

USEpilepsy-Adult monotherapy

NDAsubmitted

US

US

US

US

Canada

Development location

Depression

Neuropathic Pain, Depression

Epilepsy-Adjunct

(New indication) MDD with mixed features

Schizophrenia

Proposed indication Phase II

Phase I

Phase III

eslicarbazepineacetate

STEDESATM

TBDSEP-228432

TBDDSP-1053

lurasidone hydrochloride

LATUDA(SM-13496)

Generic nameBrand name/ Product code

4-3. Development Pipeline (CNS) as of October 31, 2011

Domestic Overseas

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0%

20%

40%

60%

80%

100%

2008 2011

4-4. More Focus in CNS and Oncology

Others

CNS

Support Technology for Oncology

Exploratory and

technology platform

ONCOLOGY(& Immunology)

Allocation of research expenses (Japan)

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4-5. Our Commitment to Oncology

High unmet medical need still existsNew breakthroughs can be expectedRequires fewer sales reps

Rationale

Approaches

Global OncologyBusiness

Development Office

Ongoing Activities(proteins, peptides,

antibodies and nucleic acids, besides small

molecules)

Research

・Promoting collaborative research with Kyoto University

・In- licensing of BBI608

Alliances/ In-licensing

Establish Global Oncology

Businessas

DSP’s New Domain

+

Develop & Execute Global Strategic Plan

Mission

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4-6. Collaborating Partners - DSP & Sunovion

Developm

entM

arketing

In-licensing Out-licensing

Joint ResearchJoint Research

Joint DevelopmentJoint Development

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•Originator: Intercept Pharmaceuticals, Inc.

•Initial territory: Japan and China•Initial indication: PBC, NASH

•Originator: Intercept Pharmaceuticals, Inc.

•Initial territory: Japan and China•Initial indication: PBC, NASH

4-7. Recent In-licensing Agreements- 4 Promising Products -

•Originator: Boston Biomedical, Inc.•Territory: Japan, Exclusive negotiation rights in North America

•Indication: all oncology indications(Option Agreement)

•Originator: Boston Biomedical, Inc.•Territory: Japan, Exclusive negotiation rights in North America

•Indication: all oncology indications(Option Agreement)

•Originator: SanBio, Inc.•Territory: U.S., Canada•Indication: stroke recovery(Option Agreement)

•Originator: SanBio, Inc.•Territory: U.S., Canada•Indication: stroke recovery(Option Agreement)

•Originator: Takeda Pharmaceutical Company Limited

•Territory: Japan•Indication: bacterial infection including MRSA infections

•Originator: Takeda Pharmaceutical Company Limited

•Territory: Japan•Indication: bacterial infection including MRSA infections

BBI608

ceftaroline fosamil

SB623

INT-747

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4-8. “Post-Latuda”Targeted areas1st Priority: CNS2nd Priority: specialty (including oncology)

Candidates for “Post-Latuda”Development pipeline in the US, DSP-8658(AD), DSP-1053(depression), etc.Compounds in pre-clinical stage in CNS and oncology areasCompounds from in-licensing and alliance activities 〔SB623(stroke), etc. 〕

Accelerate Development as“Post-Latuda”Select

candidatesEstablish POC

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Summary

DSP is making steady progress towards

Globally Competitive R&D-Oriented

Pharmaceutical Company