Progressing Towards A Globally Competitive R&D-Oriented
Transcript of 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
Summary
DSP is making steady progress towards
Globally Competitive R&D-Oriented
Pharmaceutical Company