Sumitomo Pharma Co.ltd. · TSE:4506
Sumitomo Pharma Co.ltd — Dainippon Sumitomo Pharma — 29th Annual J.P. Morgan Healthcare Conference (January 2011)
24 slides from Sumitomo Pharma Co.ltd's conference presentation, Jan 11, 2011
Slide 1: Progressing Towards an Internationally Competitive R&D-Oriented Pharmaceutical Company
Progressing Towards an Internationally Competitive R&D-Oriented Pharmaceutical Company Dainippon Sumitomo Pharma Masayo Tada President and CEO 29th Annual J.P. Morgan Healthcare Conference January 11, 2011 0
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: Company Profile
Company Profile • Created from merger of Dainippon Pharmaceutical and Sumitomo Pharmaceuticals in Oct. 2005 • FY2010 revenue (forecast) of US$4 billion* • Pharmaceutical revenue accounts for approx. 90% • No. of employees: 7,513 (consolidated, as of Sep 30, 2010) • Leverage CNS experience globally •
Slide 4: Our Key Strategic Priorities
Our Key Strategic Priorities (Mid-term Business Plan – FY2010 to 2014) Expand U.S. business through Sunovion Transform earning structure of Commercial Operations in Japan Expand new product pipeline To become an internationally competitive R&D-oriented pharmaceutical company 3
Slide 5: 1. U.S. Business
1. U.S. Business Expand U.S. business through Sunovion - U.S. market is growth driver - 4.2 Sales in Pharmaceutical sector 3.6 China (in Billion US$) China Due to contribution of SUNOVION and launch of U.S. U.S. LATUDA Japan Japan FY 2010 Forecast FY 2014 Target 4
Slide 6: 1-1. Sunovion Pharmaceuticals Inc.
1-1. Sunovion Pharmaceuticals Inc. • DSP acquired Sunovion (formerly Sepracor Inc.) in Oct. 2009 – Name change to Sunovion Pharmaceuticals in Oct. 2010 • Profile of Sunovion: – Focus in CNS and respiratory disease areas – 6 currently marketed products • Key priorities – Strengthen franchises in the
Slide 7: 1-2. Sunovion's Mid-term Revenue Forecast
1-2. Sunovion’s Mid-term Revenue Forecast (Latuda is an engine for growth) Revenues (Million US$) LATUDA® New Products 1,000 OMNARIS HFA® STEDESATM Marketed LUNESTA® XOPENEX® I.S. 0 FY2010 FY2012 FY2014 XOPENEX HFA® Forecast Forecast Forecast BROVANA® OMNARIS® ALVESCO® 6
Slide 8: 1-3. LATUDA Tablets – Overview
1-3. LATUDA® (lurasidone HCl) Tablets – Overview (Growth Driver in U.S.) • Regulatory Timeline: – – October 28, 2010 October 28, 2010 – – FDA First Cycle FDA10 Approval; Approval; 10 month review month review •• Indication: Indication: – – Treatment Treatment of of patients patients with with schizo
Slide 9: 1-4. PEARL Studies
1-4. PEARL Studies: Program to Evaluate the Antipsychotic Response to Lurasidone PEARL 1 and 2 Results (Double-blind, placebo-controlled, 6-week trials with an acute exacerbation of schizophrenia ) PEARL 1 PEARL 2 • 80 mg/d dose significantly • 40 and 120 mg/d dose groups separated from placebo on s
Slide 10: 1-5. PEARL 3 Results
1-5. PEARL 3 Results Third Study in PEARL Clinical Program • 6-week, placebo-controlled study • Two fixed-doses of lurasidone: 80 and 160 mg/day • Active comparator: quetiapine XR – 600 mg/day Note: The data for 160 mg/day dose of lurasidone has not been submitted at this point in time. 9
Slide 11: 1-6. PEARL Metabolic Results
1-6. PEARL 3 Metabolic Results PEARL 3: Weight Change (LOCF) PEARL 3: Triglycerides 5.0 Median Change from Baseline (mg/dL) Mean Change from Baseline (kg) 10.0 8.0 4.0 8.0 6.0 3.0 4.0 2.0 2.1 2.0 0.0 -2.0 0.6 -4.0 -2.0 1.0 0.6 0.1 -6.0 -8.0 0.0 -10.0 -9.0 Placebo Lur 80 mg/d Lur 160 mg/d Quet XR 600
Slide 12: 1-7. Latuda Ongoing Studies/Post-Marketing Commitments
1-7. Latuda Ongoing Studies/Post-Marketing Commitments in Schizophrenia Ongoing • Switch Study in Schizophrenia • Initiated in Q3 2010 Post Marketing Commitments • Schizophrenia Maintenance Study – Planned Start Q3 2011 • Low-dose Schizophrenia Study with 20 mg/d – Planned Start Q2 2012 • Pediatric
Slide 13: 1-8. Bipolar Depression Development Plan: PREVAIL Studies
1-8. Bipolar Depression Development Plan: PREVAIL Studies • PREVAIL: PRogram to EValuate Antidepressant Impact of Lurasidone • Ongoing global clinical trials for lurasidone in Bipolar Depression will evaluate effectiveness of lurasidone as: – Monotherapy – Adjunct therapy – Maintenance therapy • Low
Slide 14: 1-9. Market Overview
1-9. Market Overview 60,000 The atypical antipsychotic market continues to grow 47MM 48MM 49MM 50,000 44MM 2,444 2,240 2,205 2,276 6,485 Anxiety 6,631 40,000 5,699 4,903 TRx (000s) 8,374 8,557 9,341 Depression 9,215 30,000 14,893 All others 14,664 12,917 14,030 20,000 Schizophrenia 10,000 16,011 17,
Slide 15: 1-10. Latuda Commercialization Plan
1-10. Latuda Commercialization Plan • Expected Launch: February 2011 • Field Force Resources: 300 Sales Professionals • WAC Price: US$14.00 • Key Marketing Strategic Imperatives for Launch – Focus on psychiatrists treating schizophrenia – Expedite Managed Care acceptance – Maintain competitive share
Slide 16: 2. Domestic Business in Japan
2. Domestic Business in Japan Overview • Approx. 1400* sales professionals • FY2010 revenue (forecast) of approx. US$2 billion • 3 Core therapeutic areas • Strong expertise in both R&D and commercialization CNS • Many in-house assets in Schizophrenia & epilepsy • 200 CNS - specialty sales profession
Slide 17: 2-1. Initiatives taken in Japan operations
2-1. Initiatives taken in Japan operations Strategic Priority: Transform earning structure of Commercial Operations in Japan Increase in Top and Bottom- Saving in - Product Earnings Line Growth Operational Cost - Rate of New Products Intensive Value-added Promote R&D, Increase Resources in Sales fro
Slide 18: 2-2. Increasing Earnings from CNS
2-2. Increasing Earnings from CNS • Sales of Lonasen® (blonanserin), our new in-house antipsychotic agent, is expected to grow • CNS revenue in 2014 up by 30% from FY2010 forecast Shifting more to CNS FY2010 FY2014 With expected Forecast Forecast launches of new CNS products including 19% CNS 26% La
Slide 19: 3. Expand new products pipeline
3. Expand new products pipeline Status of R&D • R&D professionals: approx. 1,500 - 1,100 (Japan), 400 (U.S.), 20 (China) • R&D costs: approx. US$750 Million (FY2010 forecast) • R&D facilities: Osaka (Japan), Massachusetts, New Jersey, London, Suzhou (China) Therapeutic Strategy Other CNS + Specialty
Slide 20: 3-1. Strengthen Research in CNS Area
3-1. Strengthen Research in CNS Area Combined Strength from DSP and Sunovion Ratio of Research Programs Allocation of of Allocation Researchers Researchers Others Others CNS CNS Speciality Speciality with Sunovion with Sunovion Others Others Specialty CNS CNS Specialty 19
Slide 21: 3-2. Business Development and In-licensing through Strategic Investment
3-2. Striving in Business Development and In-licensing through Strategic Investment Primary focus is on products with early launch potential Late Stage – In-license products that can leverage the established domestic commercial base in areas such as CNS – Acquire late-stage development products by l
Slide 22: 3-3 Collaborating Partners - DSP & Sunovion
3-3 Collaborating Partners - DSP & Sunovion In-licensing Out-licensing Development Joint development Marketing 21
Slide 23: 3-4 Recent Partnerships
3-4 Recent Partnerships Joint Development of WT4869 Option Agreement with SanBio with Chugai Pharmaceutical for Co-development of SB623 l WT4869 is a therapeutic peptide Challenge for high unmet medical cancer vaccine, being developed needs with innovative approach for the treatment of various cance
Slide 24: Our Passion
Our Passion • We strive to contribute to patients around the world through delivery of innovative medicines. • As patients experience better quality of life, our sustained corporate growth is attained. We strive to achieve this goal. • In pursuit of this, we continue our active investment in R&D, mo
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