Sumitomo Pharma Co.ltd. · TSE:4506
Sumitomo Pharma Co.ltd — Dainippon Sumitomo Pharma — 30th Annual J.P. Morgan Healthcare Conference (January 2012)
29 slides from Sumitomo Pharma Co.ltd's conference presentation, Jan 9, 2012
Slide 1: Progressing Towards A Globally Competitive R&D-Oriented Pharmaceutical Company
Progressing Towards A Globally Competitive R&D-Oriented Pharmaceutical Company Dainippon Sumitomo Pharma (“DSP”) Masayo Tada President and CEO 30th Annual J.P. Morgan Healthcare Conference January 9, 2012
Slide 2: Disclaimer Regarding Forward-looking Statements
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.
Slide 3: Agenda
Agenda 1. Company Overview 2. North America Business & LATUDA 3. Japanese Business 4. Product Pipeline 2
Slide 4: Agenda
Agenda 1. Company Overview 2. North America Business & LATUDA 3. Japanese Business 4. Product Pipeline 3
Slide 5: 1-1. Profile of DSP
1-1. Profile of DSP z Created from merger of Dainippon Pharmaceutical and Sumitomo Pharmaceuticals in Oct 2005 z No. of employees: 8,026 (consolidated, as of Sep 30, 2011) z Headquartered in Osaka, Japan z Major Subsidiaries in U.S. (Sunovion Pharmaceuticals Inc.) and China Total Revenue : US$ Bil.
Slide 6: 1-2. DSP's Path Toward Our Vision
1-2. DSP’s Path Toward Our Vision Global expansion Strategic Reinforce Japan earning base Globally Objectives Competitive 2022 R&D-Oriented Enrich R&D pipeline Pharmaceutical Company 3rd 2015 2nd MTBP 2010 1st 2007 • Launch of LATUDA in the U.S. 2005 • In-licensing of 4 compounds • Acquisition of Su
Slide 7: 1-3. Our Revenue Goal in FY2014
1-3. Our Revenue Goal in FY2014 (by Regions, Pharma Business) Our Mid-term (US$Bil.) Expand Expand Business Plan US USRevenue Revenue 4.2 primarily primarilyfrom from (2010 – 2014) CHINA LATUDA’s LATUDA’s 3.8 Growth Growth N.AMERICA Maintain Maintainalmost almost Exchange Rate: flat flat revenuetren
Slide 8: Agenda
Agenda 1. Company Profile 2. North America Business & LATUDA 3. Japanese Business 4. Product Pipeline 7
Slide 9: 2-1. Profile of Sunovion
2-1. Profile of Sunovion z Established in Jan 1984 as Sepracor Inc., and acquired by DSP in Oct 2009 z No. of Employees:2,592 Sales Reps：1,530 （As of Sep 30, 2011） z Headquartered in Marlborough, MA z Net Sales： US$Mil. 1,348 (FY2011 Forecast) US$Mil. 1,340 (FY2010) z Main Products: Lunesta® (Insomn
Slide 10: 2-2. Expand North America Business with LATUDA, Our Growth Driver
2-2. Expand North America Business with LATUDA®, Our Growth Driver Revenues (US$ Mil.) 2,000 LATUDA ® LATUDA® 1,340 1,000 Marketed Marketed LUNESTA ® LUNESTA® XOPENEX ® XOPENEX®I.S. I.S. XOPENEX ® XOPENEXHFA HFA® BROVANA ® BROVANA® OMNARIS ® OMNARIS® ALVESCO ® ALVESCO® Other Othernew newproducts pro
Slide 11: 2-3. Profile of LATUDA
2-3. Profile of LATUDA® Launched Launched inin Feb. Feb. 2011 2011 in in U.S. U.S. for for Schizophrenia 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 --
Slide 12: 2-4. Atypical Antipsychotic Market (by Indications) & Future Opportunity of LATUDA
2-4. Atypical Antipsychotic Market (by Indications) & Future Opportunity of LATUDA® (Mil. TRxs) Total Market: 11% 34% US$16 Bil MDD,6.3 (2010) million MDD, TRxs6.3 Bipolar, Bipolar, 19TRxs 19 million Other*,15.7 Others*, million TRxs 15.7 29% Schizophrenia, Schizophrenia, 14.5 million TRxs 14.5 *Oth
Slide 13: 2-5. Future Prospective for LATUDA
2-5. Future Prospective for LATUDA® sNDA planned Bipolar Bipolardisorder disorder(depression) (depression) in 2012 Bipolar Bipolarmaintenance maintenance MDD MDDwith withmixed mixedfeatures features Other Otherstudies studiesunder underconsideration consideration Sales Forecast (Mil. US$) 500 Exchan
Slide 14: 2-6. Global Expansion of LATUDA
2-6. Global Expansion of LATUDA® Europe China Canada Schizophrenia Schizophrenia/ Schizophrenia NDS submitted Bipolar IND submitted (June 2011) disorder (September Co-development 2011) with Takeda Pharmaceutical U.S. (Launched) (Phase III) Japan Schizophrenia New Phase III study under preparation 13
Slide 15: 2-7. Pipeline of U.S. Pharma Business
2-7. Pipeline of U.S. Pharma Business Product Pipeline for U.S. Excluding LATUDA® (as of December 1, 2011) Brand name/ Generic name Proposed NDA Phase I Phase II Phase III submitted Product code indication TM eslicarbazepine STEDESA acetate Epilepsy-Adjunct Ciclesonide HFA (New formulation) cicleson
Slide 16: Agenda
Agenda 1. Company Profile 2. North America Business & LATUDA 3. Japan Business 4. Product Pipeline 15
Slide 17: 3-1. Japanese Pharma Market & Our Efforts-1
3-1. Japanese Pharma Market & Our Efforts-1 Japanese market is still growing, and key to our solid earning base Total: US$ (Bil.) 2005 N. America Japan Europe Others 601 Main 5 43% 11% 26% 20% 68 Still Growing 86 N. America Japan Europe Others 2010 39% 10% Main 5 34% 861 17% 0 200 400 600 800 1000 C
Slide 18: 3-2. Japanese Pharma Market & Our Efforts-2
3-2. Japanese Pharma Market & Our Efforts-2 - Contribution of Our New Products - Sales 179 180 179 178 175 172 (Bil. Yen) Marketed New Products 100 DSP’s Sales 0 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011 Forecast NHI Price Cut & NHI Price Cut Amlodipine generic NHI Price Cut Ⓡ AmBisomeⓇ Replagal LON
Slide 19: 3-3. Strategy for Japan Pharma Business
3-3. Strategy for Japan Pharma Business Product Pipeline for Japan (as of December 1, 2011) Brand name/ Generic name Proposed NDA Phase I Phase II Phase III submitted Product code indication amlodipine Hypertension / DSP-8153 besilate/irbesartan Combination agent NDA submitted in Nov. 2011 lurasidon
Slide 20: Agenda
Agenda 1. Company Profile 2. North America Business & LATUDA 3. Japanese Business 4. Product Pipeline 19
Slide 21: 4-1. Product Pipeline: Current Status & Our Strategy
4-1. Product Pipeline Current Status & Our Strategy Current Status z R&D professionals: approx. 1,500 - 1,040 (Japan), 450 (U.S.), 20 (China) z R&D costs: approx. US$ Mil. 740 (FY2011 forecast) z R&D facilities: Osaka (Japan), Massachusetts, New Jersey, London, Suzhou (China) Therapeutic Strategy –
Slide 22: 4-2. DSP's Strong Expertise in CNS
4-2. DSP’s Strong Expertise in CNS - Our Strong Track Record ultimately led to LATUDA - Our Major Marketed LATUDA LATUDA® ® Products (Schizophrenia) (Schizophrenia) LUNESTA ® LUNESTA® (Insomnia) (Insomnia) LONASEN® Originally LONASEN®(Schizophrenia) (Schizophrenia) launched by TRELIEF ® predecessors
Slide 23: 4-3. Development Pipeline (CNS) as of October 31, 2011
4-3. Development Pipeline (CNS) as of October 31, 2011 Domestic Overseas Brand name/ Generic name Proposed indication Development Phase Phase Phase NDA Product code location I II III submitted LATUDA lurasidone Schizophrenia Canada (SM-13496) hydrochloride (Change of maximum dose) Schizophrenia: US
Slide 24: 4-4. More Focus in CNS and Oncology
4-4. More Focus in CNS and Oncology Allocation of research expenses (Japan) 100% Others 80% Exploratory and technology Support platform Technology 60% for Oncology ONCOLOGY (& Immunology) 40% 20% CNS 0% 2008 2011 23
Slide 25: 4-5. Our Commitment to Oncology
4-5. Our Commitment to Oncology Rationale zHigh unmet medical need still exists zNew breakthroughs can be expected zRequires fewer sales reps Approaches Research Alliances/ Establish In-licensing Ongoing Activities ・Promoting collaborative Global Oncology Business (proteins, peptides, antibodies and
Slide 26: 4-6. Collaborating Partners - DSP & Sunovion
4-6. Collaborating Partners - DSP & Sunovion Joint JointResearch Research Joint JointDevelopment Development In-licensing Out-licensing Development Marketing 25
Slide 27: 4-7. Recent In-licensing Agreements
4-7. Recent In-licensing Agreements - 4 Promising Products - SB623 BBI608 •Originator: •Originator:SanBio, SanBio,Inc. Inc. •Originator: •Originator:Boston BostonBiomedical, Biomedical,Inc. Inc. •Territory: •Territory:Japan, Japan,Exclusive Exclusive •Territory: •Territory:U.S., U.S.,Canada Canada n
Slide 28: 4-8. "Post-Latuda"
4-8. “Post-Latuda” Targeted areas 1st Priority: CNS 2nd Priority: specialty (including oncology) Candidates for “Post-Latuda” z Development pipeline in the US, DSP-8658（AD）, DSP-1053（depression）, etc. z Compounds in pre-clinical stage in CNS and oncology areas z Compounds from in-licensing and a
Slide 29: Summary
Summary DSP is making steady progress towards Globally Competitive R&D-Oriented Pharmaceutical Company
Dainippon Sumitomo Pharma — 30th Annual J.P. Morgan Healthcare Conference (January 2012) on 6ix