Roche Holding Ltd · SIX:RO
Roche — Non-Deal Roadshow (2001)
43 slides from Roche's roadshow presentation, 2001
Slide 1: Nippon Roche's Growth Potential
r Pharmaceuticals Nippon Roche’s Growth Potential William M. Burns Head of the Pharmaceuticals Division F. Hoffmann – La Roche Ltd.
Slide 2: Disclaimer
r Pharmaceuticals Disclaimer This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as “believes”, “expects”, “anticipates”, “projects”, “intends”, “should”, “seeks”, “estimates”, “future” or similar expressions or by discussio
Slide 3: Today's Agenda
r Pharmaceuticals Today’s Agenda • Historical Financials • Key Products Responsible for Near-Term Growth – Backbone Products – Current Growth Drivers – Next Product Launches • Key Developments for the Future • Global Pharmaceuticals Pipeline • Nippon Roche’s Outlook
Slide 4: Historical Financials
r Pharmaceuticals Historical Financials
Slide 5: Historical Net Sales
r Pharmaceuticals Historical Net Sales (JPY billions) 80 74.4 70 65.1 Pharma Rx Direct 60 Up 14.3% Sales (1) 50 Pharma Rx Agent 57.7 Sales (2) 40 47.5 Others (3) 30 Up 21.5% 20 10 13.9 14.3 3.6 2.4 0 2000 2001(E) (1) Finished Products marketed and promoted by Nippon Roche (2) Products sold to other
Slide 6: Historical Sales of Key Products
r Pharmaceuticals Historical Sales of Key Products Sales (JPY millions) 1999-2001E Brand Name FY1999 FY2000 YoY Chg. FY2001E YoY Chg. CAGR Furtulon 19,138 19,575 2.3 % 19,576 0.0 % 1.1 % Kytril 308 9,430 Rohypnol 3,782 4,115 8.8 4,236 2.9 5.8 Rocephin 3,637 4,048 11.3 4,063 0.4 5.7 Rocaltrol Oral 3,
Slide 7: Summary Historical Profit and Loss Figures
r Pharmaceuticals Summary Historical Profit and Loss Figures FY2000 FY2001E Total Sales 65,071 74,397 YoY 14.3% Gross Profit 39,301 43,614 YoY 11.0% Operating Profit 9,630 10,790 YoY 12.0%
Slide 8: Key Products Responsible for Near-Term Growth
r Pharmaceuticals Key Products Responsible for Near-Term Growth
Slide 9: Key Products – Backbone Products
r Pharmaceuticals Key Products – Backbone Products Furtulon Furtulon Kytril
Slide 10: Backbone Products: Furtulon
r Pharmaceuticals Backbone Products (JPY billions) • Furtulon 20 – 5-FU market declining by approximately 5% 15 – Furtulon maintaining 10 19.1 19.6 19.6 18.8 approximately 25% market share 5 – Broad Indications (Breast Cancer, Colorectal Cancer, 0 ) ) 99 00 (E (E Gastric Cancer,etc.) 19 20 01 02 20
Slide 11: Backbone Products: Kytril
r Pharmaceuticals Backbone Products (JPY billions) • Kytril* 15 – Maintaining leading position in the market (over 10 50% market share) – Continued Phase IV investments to demonstrate5 9.5 9.4 benefits in new cancer treatment regimens – Slight growth in sales for 0 2001(E) 2002(E) the near future Ne
Slide 12: Key Products – Current Growth Drivers
r Pharmaceuticals Key Products – Current Growth Drivers Tamiflu Rituxan Herceptin CellCept
Slide 13: Current Growth Drivers: Tamiflu
r Pharmaceuticals Current Growth Drivers (JPY billions) • Tamiflu 15 – 75% market share vs Relenza after first season 10 – Paediatrics launch in 2002 11.0 11.5 – Flu incidence dependent 5 6.3 0 ) ) ) (E (E (E 01 02 05 20 20 20 Net Sales
Slide 14: Current Growth Drivers: Herceptin
r Pharmaceuticals Current Growth Drivers (JPY billions) • Herceptin 10 – Launched for Metastatic Breast Cancer (MBC) in June 2001 5 – Rapid adoption in first 6 months launch 5.2 3.7 – Establish Herceptin as 1.4 0 highly effective and safe ) ) ) (E (E (E drug for HER2 (+) MBC 01 02 05 20 20 20 – Expa
Slide 15: Current Growth Drivers: Rituxan
r Pharmaceuticals Current Growth Drivers (JPY billions) • Rituxan 10 – Launched for low grade Non-Hodgkin’s Lymphoma (NHL) in September 2001 5 8.2 – Rapid adoption in first 4 months after launch 5.1 2.0 – Establish Rituxan as first 0 line position for low grade ) ) ) (E (E (E NHL (Monotherapy and 01
Slide 16: Current Growth Drivers: CellCept
r Pharmaceuticals Current Growth Drivers (JPY billions) • CellCept 5 – Approximately 70% growth 4 over last year 3 – Roche #2 in Transplant Market worldwide 2 3.0 – Renal prevention indication 1 launched in 2001 1.1 1.6 – Establish low toxicity 0 2001(E) immuno-suppressive regimen with CellCept as N
Slide 17: Key Products – Next Product Launches
r Pharmaceuticals Key Products – Next Product Launches Xeloda Pegasys
Slide 18: Next Product Launches: Xeloda
r Pharmaceuticals Next Product Launches • Xeloda – Currently Marketed in over 90 countries – Expected launch in Japan in 2002 in Breast Cancer – Phase II in Japan for Colorectal Cancer & Gastric Cancer (Colorectal Cancer launched in US & EU) – Approval of Xeloda / docetaxel combination in first / se
Slide 19: Combination Data of Xeloda and Taxotere
r Pharmaceuticals Combination Data of Xeloda and Taxotere® Women Lived Longer 1.0 Women with metastatic breast cancer live 3 months longer when Xeloda is 0.8 added to Taxotere® (median) Probability 0.6 Xeloda and Taxotere® 0.4 Taxotere® alone 0.2 11.5 14.5 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 T
Slide 20: Key Developments for the Future
r Pharmaceuticals Key Developments for the Future
Slide 21: Key Products – Developments for the Future
r Pharmaceuticals Key Products – Developments for the Future Xenical Bonviva
Slide 22: Developments for the Future: Xenical and Bonviva
r Pharmaceuticals Developments for the Future • Xenical • Bonviva – World leading anti-obesity – Global phase III treatment Rx medicine trial recently completed: – Worldwide sales for 2000 = promising results with both approximately USD 592 daily and intermittent oral million regimens. Data to be –
Slide 23: Global Pharmaceuticals Pipeline
r Pharmaceuticals Global Pharmaceuticals Pipeline
Slide 24: Fueling the R&D pipeline at Roche
r Pharmaceuticals Fueling the R&D pipeline at Roche Lead Optimization RESE Phase 0 ARCH type 2 diabetes Phase I alzheimer’s Benign prostatic DEVE Phase II hypertrophy LOPM Phase III/ asthma type 2 diabetes alzheimer’s EN T type 2 diabetes alzheimer’s thromboembolism HIV Registration carcinoma carcin
Slide 25: Roche R&D pipeline NMEs in development
r Pharmaceuticals Roche R&D pipeline 28 NME’s in development at Roche Phase III / Phase 0 Phase I Phase ll Registration R944 HIV R411 asthma R440 (CCI) solid tumors R420 (Pegasys) HCV R1067 depression R545 overactive bladder R450 (alpha 1 agonist) R484 (Bonviva) osteoporosis stress incontinence R112
Slide 26: Roche R&D pipeline plus opt-in projects
r Pharmaceuticals Roche R&D pipeline …plus 13 ‘opt-in’ projects gives 41 NME’s Phase III / Phase 0 Phase I Phase ll Registration R944 HIV R411 asthma R440 (CCI) solid tumors R420 (Pegasys) HCV R1067 depression R545 overactive bladder R450 (alpha 1 agonist) R484 (Bonviva) osteoporosis stress incontin
Slide 27: Roche R&D pipeline plus Genentech NMEs
r Pharmaceuticals Roche R&D pipeline ...plus 5 Genentech NMEs which Genentech will commercialise alone gives 46 NMEs Phase III / Phase 0 Phase I Phase ll Registration R944 HIV R411 asthma R440 (CCI) solid tumors R420 (Pegasys) HCV R1067 depression R545 overactive bladder R450 (alpha 1 agonist) R484
Slide 28: NMEs focused primarily in therapy areas
r Pharmaceuticals Roche R&D pipeline 46 NME’s focused primarily in 7 therapy areas Phase III / Phase 0 Phase I Phase ll Registration R944 HIV R411 asthma R440 (CCI) solid tumors R420 (Pegasys) HCV R1067 depression R545 overactive bladder R450 (alpha 1 agonist) R484 (Bonviva) osteoporosis stress inco
Slide 29: R667 in emphysema
r Pharmaceuticals R667 in emphysema Rebuilding lung tissue / improving lung function e I has p • A selective retinoid agonist (RAR-γ) • First compound able to regenerate lung tissue (in animal studies) • Restores lung function in animal models • Potential to reverse the disease process • Selectivity
Slide 30: R411 in asthma
r Pharmaceuticals R411 in asthma Novel selective integrin antagonist e I has p • Selectively targets the underlying disease pathology • Powerful inhibitor of inflammatory cell infiltration • Side effect-free profile in animal studies • Potentially superior safety to inhaled corticosteroids • Better
Slide 31: R450 in stress urinary incontinence
r Pharmaceuticals R450 in stress urinary incontinence (SUI) Potent non-surgical treatment e II has p • Over 48 million patients in major markets • No globally approved drug therapy with SUI indication • High unmet need for a non-surgical treatment • In preclinical tests, potent effects on bladder ou
Slide 32: R483 in type II diabetes
r Pharmaceuticals R483 in type 2 diabetes II** a se ph • The insulin sensitizer with dual effect – - Significant increase in insulin sensitivity – - Significant inhibition of endogenous glucose production • Best in class insulin sensitizer – - Target profile is for superior efficacy in glycemic cont
Slide 33: R483 in type II diabetes: highlights
r Pharmaceuticals R483 in type 2 diabetes II** a se ph • Pre-clinical highlights – The strongest activation of PPARg receptors compared to competitive compounds – The maximum improvement of insulin sensitivity and inhibition of glucose production in clamp studies (dual effect), compared to other ins
Slide 34: R673 in depression and anxiety
r Pharmaceuticals R673 in depression and anxiety II** a se ph • R673 is expected to have improved tolerability compared to SSRI’s and superior CNS bioavailability to identified competitor compounds • Excellent brain penetration can be shown functionally in animals and man • No drug/drug interactions
Slide 35: Roche R&D pipeline: Just some of the NMEs
r Pharmaceuticals Roche R&D pipeline Just 5 of the 46 NME’s under development Phase III / Phase 0 Phase I Phase ll Registration R944 HIV R411 asthma R440 (CCI) solid tumors R420 (Pegasys) HCV R1067 depression R545 overactive bladder R450 (alpha 1 agonist) R484 (Bonviva) osteoporosis stress incontine
Slide 36: Roche R&D pipeline Summary
r Pharmaceuticals Roche R&D pipeline Summary • Substantial investments in process re-engineering and research technologies • World class capability in research and development • Research investments beginning to bear fruit • A pipeline of quantity and quality
Slide 37: Nippon Roche's Outlook
r Pharmaceuticals Nippon Roche’s Outlook
Slide 38: Product mix in Rx Direct Net Sales by Launch Date
r Pharmaceuticals Product mix in Rx Direct Net Sales by Launch Date 100% 90% 17% 30% 80% 40% 50% 54% 70% 60% New Launches 2001 and after 50% Launched before 2001* 40% 83% 70% 30% 60% 50% 46% 20% 10% 0% 2001(E) 2002 2003 2004 2005 (E) (E) (E) (E) * Includes Kytril
Slide 39: Long-Listed Products
r Pharmaceuticals Long-Listed Products* 2001(E) 2002(E) 15.0% 11.4 % Long-Listed Long-Listed Products Products 85.0 % 88.6 % Others Others * Products Marketed by Nippon Roche
Slide 40: Breakdown of Rx Direct Net Sales by Therapeutic Area
r Pharmaceuticals Breakdown of Rx Direct Net Sales by Therapeutic Area FY 2000 FY 2005 (E) 2.1 % 0.8 % 9.3 % Transplant Virology Virology 2.6 % 5.3 % 4.0 % & Immunology All Others All Others Transplant & Immunology 42.5 % 3.6 % 7.0 % Bone & Oncology Bone & Inflammatory Inflammatory 8.5 % Central Ner
Slide 41: Sales and Profit Outlook
r Pharmaceuticals Sales and Profit Outlook Total Sales (JPY billions) High single-digit 80 74.4 CAGR 2000-2005 Operating Profit 70 65.1 Double-digit 60 Up 14.3% Rx Direct Sales CAGR 2000-2005 50 Double-digit 57.7 CAGR 40 47.5 2000-2005 Up 21.5% 30 Pharma Rx Direct 20 Sales (1) Pharma Rx Agent 10 13.
Slide 42: Summary of Nippon Roche's Outlook
r Pharmaceuticals Summary of Nippon Roche’s Outlook n Tamiflu, Rituxan, Herceptin, and CellCept to drive near-term top-line growth n Additional new products such as Xeloda and Pegasys are expected to fuel further growth n Receives continued benefits from Roche’s rich global pipeline after 2005 n Dou
Slide 43: Pharmaceuticals
r Pharmaceuticals