NSCLC (Update) • Cotellic + Zelboraf: Phase III 1L Melanoma (Cobrim), Overall Survival
Total Page:16
File Type:pdf, Size:1020Kb
Roche YTD September 2015 sales Basel, 22 October 2015 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 discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected. 3 Group Severin Schwan Chief Executive Officer 4 Q3 2015: Guidance upgraded to mid-single digit sales growth1, Core EPS ahead of sales growth2 Growth YTD Sept Sales • Group sales +6%1 driven by HER2 franchise (+19%), Avastin (+9%), Actemra (+22%) and Professional Diagnostics (+7%) • Outperformance in all major regions: US (+6%1), Europe (+3%1), Japan (+6%1) and International (+8%1) Innovation Oncology • Atezolizumab: Phase II lung (POPLAR, BIRCH); Phase II bladder (IMvigor 210) • Alectinib: Phase II in 2L ALK+ NSCLC (update) • Cotellic + Zelboraf: Phase III 1L melanoma (coBRIM), overall survival Neuroscience • Ocrelizumab: – Phase III RMS (OPERA I/II) met primary and key secondary endpoints – Phase III PPMS (ORATORIO) met primary and key secondary endpoints Diagnostics • Launch of cobas EGFR Mutation Test v2 - first Roche liquid biopsy PCR test 1 At constant exchange rates (CER) 5 2 Excluding sale of filgrastim rights in 2014 YTD Sept 2015: Strong sales growth continues 2015 2014 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 27.7 27.0 3 6 Diagnostics Division 7.8 7.8 1 6 Roche Group 35.5 34.8 2 6 CER=constant exchange rates 6 Q3 2015: Sales growth for fifth consecutive year 10% 8% 8% 7% 7% 6% 6% 6% 6% 6% 6% 5% 5% 4% 5% 4% 4% 4% 4% 2% 2% 0% 0% 1% 0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 11 11 11 11 12 12 12 12 13 13 13 13 14 14 14 14 15 15 15 All growth rates at constant exchange rates (CER) 7 YTD Sept 2015: Strong sales growth in all regions CHFbn 18 +6% 15 +1% 12 +3% +8% 9 Diagnostics +2% +14% +7% Pharma 6 +6% -5% +3% 3 +6% +8% 0 Japan International Europe US All growth rates at constant exchange rates (CER) 8 Roche: Significantly advancing patient care Recognising innovation 2013-15 Breakthrough Therapy 9 Designations Actemra (Systemic sclerosis) Venetoclax (R/R CLL 17p) YTD 2015 Rank Company # Atezolizumab (NSCLC) 1 Roche 9 ACE 910 (Hemophilia) 2 BMS 8 Esbriet (IPF) 3 Novartis 6 2014 Lucentis (DR) 4 GSK 5 Atezolizumab (Bladder) 4 Merck 5 Alectinib (2L ALK+ NSCLC) 2013 5 JNJ 4 Gazyva (1L CLL) Source: http://www.focr.org/breakthrough-therapies as at 9 September 2015; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non- 9 Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy Pharma: Making a difference for patients Significant opportunities ahead Year Molecule Indication Trial name Event Alectinib ALK+ NSCLC AF-002JG, ACCALIA NME filed 2015 Cotellic+Zelboraf BRAFV600 melanoma coBRIM NME filed Venetoclax 17p del R/R CLL NME filing Atezolizumab 2/3L NSCLC, bladder BIRCH, POPLAR, Imvigor 210 NME filing Ocrelizumab RMS, PPMS OPERA I/II, ORATORIO NME filing 2016 Lebrikizumab Asthma LAVOLTA I/II, ACOUSTICS Pivotal data Perjeta+Herceptin Adjuvant HER2+ breast APHINITY Pivotal data Gazyva Front-line aNHL GOYA Pivotal data ACE 910 Hemophila A Pivotal data Lampalizumab Geographic atrophy CHROMA, SPECTRI Pivotal data 2017 Gazyva 1L iNHL GALLIUM Pivotal data Atezolizumab+chemo 1L NSCLC IMpower 110/150/130/111/131 Pivotal data Oncology Neuroscience Ophthalmology Immunology Timelines may change as trials can be event-driven NME=new molecular entity; NSCLC=non-small cell lung cancer; CLL=chronic lymphoid leukemia; RMS=relapsing multiple sclerosis 10 (MS); PPMS=primary progressive MS; aNHL=aggressive non-hodgkin`s lymphoma; iNHL=indolent non-hodgkin`s lymphoma 2015 outlook: Guidance upgraded Group sales growth1 Mid-single digit Core EPS growth1 Ahead of sales growth2 Dividend outlook Further increase dividend in Swiss francs 1 At constant exchange rates (CER) 11 2 Excluding sale of filgrastim rights in 2014 Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals 12 YTD Sept 2015 sales Innovation Outlook 13 YTD Sept 2015: Pharma sales Strong growth driven by all regions 2015 2014 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 27,690 26,965 3 6 United States 13,047 11,528 13 7 Europe 6,476 7,070 -8 3 Japan 2,341 2,406 -3 8 International 5,826 5,961 -2 6 CER=constant exchange rates 14 YTD Sept 2015: Strong performance from oncology and immunology franchises Herceptin +10% Avastin +9% Perjeta +66% Esbriet n.a. MabThera/Rituxan +5% Kadcyla +57% Actemra/RoActemra +22% Xolair +25% Lucentis -15% US Xeloda -36% Europe Valcyte/Cymevene -47% Japan International Pegasys -48% -500 -250 0 250 500 CHFm Absolute amounts and growth rates at constant exchange rates (CER) 15 YTD Sept 2015: Oncology with +8% growth YoY CER growth Perjeta HER2 Herceptin +19% • Strong uptake of Perjeta and Kadcyla • Growth of Herceptin due to longer treatment Kadcyla • Growth driven by ovarian and cervical Avastin +9% • International: Growth in all regions MabThera/ Rituxan +4% • US: Growth in iNHL maintenance (Oncology) Tarceva -7% • In-class competition Xeloda -36% • Loss of exclusivity • Competitive pressure in US and EU Zelboraf -25% • Cotellic + Zelboraf approval expected in 2015 CHFbn 0 1 2 3 4 5 6 7 CER=constant exchange rates 16 YTD September 2015 Oncology sales: CHF 17.6bn; CER growth +8% HER2 franchise: Growth driven by Herceptin, Perjeta and Kadcyla CHFm YoY CER growth 2,500 HER2 franchise Q3 2015 +16% • Herceptin (+7%): Longer treatment +23% 2,000 duration in combination with Perjeta +15% • Perjeta (+57%): Strong demand in 1L +16% mBC (US & EU) and neoadjuvant (US) 1,500 • Kadcyla (+44%): Growth driven by EU 1,000 Outlook • Perjeta: Neoadjuvant approval in the EU 500 achieved in Q3 ’15 • Kadcyla: Continued growth to be driven 0 by EU and International Q3 12 Q3 13 Q3 14 Q3 15 Herceptin Perjeta Kadcyla CER=constant exchange rates 17 Avastin: Growth in various indications and across all regions CHFm YoY CER growth Avastin Q3 2015 +6% +8% +14% • US (+6%): Continued uptake in lung, 1,600 +11% ovarian and cervical cancer • EU (+5%): Growth in ovarian and cervical 1,200 • International (+16%): Driven by LATAM and China 800 Outlook 400 • Potential filing in mesothelioma • China: Lung cancer indication launched 0 • EU: Avastin + Tarceva filed in lung cancer Q3 12 Q3 13 Q3 14 Q3 15 US Europe International Japan CER=constant exchange rates 18 Immunology: Strong performance by Xolair, Actemra and MabThera/Rituxan CHFm YoY CER growth +23% Xolair (+21%) 1,600 • Allergic asthma and strong growth in +15% +15% chronic idiopathic urticaria due to 1,200 +6% longer treatment duration Actemra (+18%) 800 • SC formulation driving growth • Increasing 1L monotherapy leadership 400 focusing on MTX intolerant patients MabThera/Rituxan (+10%) 0 • Continues to grow in rheumatoid Q3 12 Q3 13 Q3 14 Q3 15 arthritis and vasculitis (GPA and MPA) MabThera/Rituxan (RA) Actemra IV Actemra SC Xolair CellCept Pulmozyme Esbriet Other CER=constant exchange rates; MTX=methotrexate; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis 19 Actemra: Continued uptake in 1L monotherapy SC formulation driving growth in the EU and US CHFm YoY CER growth 400 +18% 350 +28% +20% +27% +23% +21% 32% 300 +33% +23% +23% +33% 250 +30% +32% +27% +32% 200 +46% 150 68% 100 50 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 12 12 12 12 13 13 13 13 14 14 14 14 15 15 15 IV SC CER=constant exchange rates; IV=intravenous formulation; SC=subcutaneous formulation 20 Lucentis: Competitive pressure continues; ophthalmology pipeline progresses Lucentis Q3 2015 Lucentis sales (USDm) • Competitive pressure 500 Outlook • Ongoing competition in AMD & DME 400 • Launch in DR ongoing after first-in- class FDA approval in Q1 2015 Pipeline update ophthalmology 300 • Phase II Port Delivery System study for Lucentis started (expect data 2017) • Anti-VEGF/Ang2 biMab moved into 200 phase II in wAMD Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 • Lampalizumab phase III studies in GA 12 12 13 13 13 13 14 14 14 14 15 15 15 well on track (expect data 2017) wAMD=wet age-related