Avastin + Letrozole
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Roche Q1 2015 sales Basel, 22 April 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 Q1 2015: Highlights Growth • Group sales +5%1 driven by HER2 franchise (+23%1), Avastin (+6%1), Actemra (+27%1) and Professional Diagnostics (+6%1) • Esbriet: Off to a strong start Innovation • Second Breakthrough Therapy Designation for anti-PDL1 • Phase 3 starts: Seven in immuno-oncology, etrolizumab in Crohn’s disease and taselisib in HR+ breast cancer M&A • Foundation Medicine: Transaction closed 1 CER=Constant Exchange Rates 5 Q1 2015: Strong sales growth 2015 2014 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 9.3 9.0 3 4 Diagnostics Division 2.5 2.5 2 6 Roche Group 11.8 11.5 3 5 CER=Constant Exchange Rates 6 Q1 2015: Continued strong growth in all regions CHFbn 6 +6% 5 +3% 4 +1% +10% 3 Diagnostics +3% +14% +6% Pharma 2 -3% * +1% 1 -10% +9% -2% 0 Japan International Europe US * Japanese sales impacted by consumption tax base effect CER=Constant Exchange Rates 7 Q1 2015: Sales growth for 5th consecutive year 10% 8% 8% 7% 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 11 11 11 11 12 12 12 12 13 13 13 13 14 14 14 14 15 All growth rates at Constant Exchange Rates (CER) 8 Progressing in Personalised Healthcare 60% of phase 2 & 3 products have PHC component Phase 2 Phase 3/Registration Marketed FIXa/FX bispecific MAb MAO-B inh PD-L1 MAb Tarceva® SERD GABRA5 NAM venetoclax (Bcl-2 inh) Zelboraf® CSF-1R MAb bitopertin alectinib (ALK inh) Erivedge® Ang2-VEGF MAb basimglurant taselisib Rituxan® ipatasertib V1 receptor antag cobimetinib Gazyva® polatuzumab vedotin crenezumab lebrikizumab Herceptin® lifastuzumab vedotin olesoxime etrolizumab Perjeta® gantenerumab glypican-3 MAb danoprevir Kadcyla® Flu A MAb ocrelizumab Avastin® LptD antibiotic lampalizumab Xeloda® Esbriet® Pulmozyme® Oncology Molecular Diagnostics Xolair® Immunology Tissue Diagnostics Infectious Diseases Actemra® Professional Diagnostics Neuroscience Lucentis® Ophthalmology 9 Roche: Making progress in advancing patient care Recognising innovation 2012-15 Breakthrough Therapy 6 Designations Rank Company # Q1 2015 Anti-PDL1 (NSCLC) 1 Roche 6 Esbriet 1 GSK 6 2014 Lucentis Diabetic Retinopathy 3 Novartis 5 Anti-PDL1 (bladder) 4 Merck 4 Alectinib 2013 5 JNJ 4 Gazyva Source: FDA 10 2015 outlook Group sales growth1 Low to mid-single digit Core EPS growth1 Ahead of sales growth2 Dividend outlook Further increase dividend in Swiss francs 1 At constant exchange rates 11 2 Excluding sale of filgrastim rights in 2014 Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals 12 Q1 2015 sales Innovation Outlook 13 Q1 2015: Strong sales growth driven by US and International 2015 2014 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 9,322 9,040 3 4 United States 4,392 3,873 13 6 Europe 2,178 2,425 -10 1 Japan 763 845 -10 -2 International 1,989 1,897 5 9 CER=Constant Exchange Rates 14 Q1 2015: Strong performance from oncology and immunology franchises; Esbriet off to a good start Herceptin +12% Perjeta +82% Esbriet n.a. MabThera/Rituxan +5% Avastin +6% Kadcyla +80% Actemra/RoActemra +27% Xolair +28% Lucentis -9% US Valcyte/Cymevene -41% Europe Pegasys -39% Japan International Xeloda -53% -200 -150 -100 -50 0 50 100 150 200 CHFm Absolute amounts and growth rates at Constant Exchange Rates (CER) 15 Q1 2015: Oncology products with +6% growth YoY CER growth Perjeta • Strong uptake of Perjeta & Kadcyla HER2 Herceptin +23% +23% • Accelerated growth of Herceptin Kadcyla • US: Continued uptake in ovarian, cervical and lung Avastin +6%+6% • EU: Growth in ovarian and breast MabThera/ Rituxan +4% • Increased usage across a variety of indications Tarceva --3%3% • In-class competition Xeloda --53%53% • Loss of exclusivity • Competitive pressure in US & EU Zelboraf --25%25% • Approval of coBRIM expected in 2015 CHFbn 0 1 2 CER=Constant Exchange Rates; Q1 2015 Oncology sales: CHF 5.8bn 16 HER2 franchise: Growth of Perjeta also driving Herceptin sales CHFm YoY CER growth 2'400 23% 23% 19% 23% 17% 20% 1'800 15% 7% 15% 1'200 600 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 13 13 13 13 14 14 14 14 15 Kadcyla Perjeta Herceptin CER=Constant Exchange Rates 17 Herceptin SC launched in 44 countries Conversion rate already exceeds 30% Number of countries where SC share of Herceptin sales in Herceptin SC has been launched launched countries 50 35% 30% 40 25% 30 20% 20 15% 10% 10 Sales market (%) Sales market share 5% Total number of countries of countries number Total 0 0% Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 13 13 13 14 14 14 14 15 13 13 13 14 14 14 14 15 18 Avastin: Strong growth across various indications and in all regions CHFm YoY CER growth 1'800 +9% +6% +11% Avastin Q1 2015 1'500 +1% • Main growth drivers are ovarian 1'200 (US; EU), lung (US) and cervical cancer (US) 900 • EU: Positive momentum in breast 600 cancer due to IMELDA • International (+11%) in all regions 300 Outlook 0 • EU launch in cervical cancer Q1 12 Q1 13 Q1 14 Q1 15 US Europe International Japan CER=Constant Exchange Rates 19 Immunology franchise remains driven by Actemra, Xolair and MabThera/Rituxan CHFm YoY CER growth 1'500 +20% • Actemra (+27%): SC launch and +11% +11% 1L monotherapy setting +5% 1'000 • Xolair (+28%): Allergic asthma and strong growth in Chronic Idiopathic Urticaria (CIU) post 500 FDA approval in Q1 ‘14 • MabThera/Rituxan (+11%): 0 Continues to grow in rheumatoid Q1 12 Q1 13 Q1 14 Q1 15 arthritis and vasculitis (GPA and Other (incl Esbriet) Pulmozyme MPA) CellCept Xolair Actemra SC Actemra IV MabThera/Rituxan GPA=Granulomatosis with polyangiitis; MPA=Microscopic polyangiitis 20 CER=Constant Exchange Rates Ophthalmology franchise: Competitive pressure on Lucentis; Fast Track status for lampalizumab USDm Lucentis sales Lucentis Q1 2015 500 • Continued competitive pressure in wAMD • First-in-class FDA approval to treat diabetic retinopathy (DR) in patients 400 with DME AMD Less-frequent than Lucentis outlook monthly dosing • Ongoing competition in AMD & DME 300 Lucentis • First sales in DR DME Lampalizumab update • FDA granted Fast Track status for 200 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 geographic atrophy (GA) 12 12 12 12 13 13 13 13 14 14 14 14 15 • Ph3 global enrollment well on track wAMD=wet age-related macular degeneration; DME=diabetic macular edema 21 Esbriet: Off to a strong start Esbriet sales (CHFm) 88 US launch off to strong start • Patients still in transition to full reimbursement post approval 44 • Establishing market leadership in IPF 36 32 27 European sales with continued growth • Label was strengthened by including ASCEND and pooled 1Y mortality data Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 22 Q1 2015 sales Innovation Outlook 23 Gazyva: First positive readout in iNHL CLL11: Ph III front-line chronic lymphocytic leukemia (CLL) Gazyva 1000mg IV + chlorambucil Front-line CLL MabThera/Rituxan + Primary end-point: PFS n=781 chlorambucil Approved in Q4 2013 chlorambucil GADOLIN: Ph III MabThera/Rituxan refractory indolent non-Hodgkin`s lymphoma (iNHL) Induction Maintenance CR, PR, Gazyva SD Gazyva + bendamustine q2mo x 2 years MabThera-refractory iNHL x 6 cycles Primary end-point: PFS n=411 Data at ASCO 2015 bendamustine x 6 cycles GOYA: Ph III diffuse large B-cell lymphoma (DLBCL) Gazyva x 8 cycles + Front-line DLBCL CHOP x 6 or 8 Primary end-point: PFS (aggressive NHL) n=1,418 MabThera x 8 cycles + CHOP x Trial to continue until 2016 6 or 8 GALLIUM: Ph III front-line indolent non-Hodgkin`s lymphoma (iNHL) Induction Maintenance Gazyva x 8 cycles + CHOP x 6 or Gazyva Gazyva x 8 cycles + CVP x 8 or q2mo x 2 years Front-line iNHL Gazyva x 6 cycles + benda. x 6 Primary end-point: PFS n=1,401 CR, PR Enrolment complete Q1 2014 MabThera x 8 cycles + CHOP x 6 or MabThera x 8 MabThera Data expected 2017 cycles + CVP x 8 or MabThera x 6 cycles + benda.