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Daniel O`Day COO Roche Pharma Boston, March 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 2 3 4 5 6 7 8 9 10 11 pricing and product initiatives of competitors; legislative and regulatory developments and economic conditions; delay or inability in obtaining regulatory approvals or bringing products to market; fluctuations in currency exchange rates and general financial market conditions; 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; increased government pricing pressures; interruptions in production; loss of or inability to obtain adequate protection for intellectual property rights; litigation; loss of key executives or other employees; and 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 Performance update Foundation Medicine acquisition Pharma pipeline update Outlook 4 2014: Targets achieved Targets for 2014 Group sales Low to mid-single digit growth1 FY 2014 +5% +5% Core EPS Ahead of sales growth1 +7% excl. one-time US Pharma fee2 Dividend Further increase dividend3 CHF 8.00 +3% At constant exchange rates One-time double charge of CHF 202m for the US Branded Prescription Drug fee in 2014, following final regulations issued by the US Internal Revenue Service which advanced the timing of recording the liability 3 2014 dividend as proposed by the Board of Directors 1 2 5 2014: Highlights Growth • Group sales +5%1 driven by HER2 franchise (+20%1), Avastin (+6%1), Actemra (+23%1) and Professional Diagnostics (+8%1) • Outperformance in all major regions: +6%1 in US, Japan & International; +3%1 in Europe Innovation • Three Breakthrough Therapy Designations: Anti-PDL1, Esbriet and Lucentis • Three Fast Track Designations: Lampalizumab, cobimetinib and LptD (antibiotic) • Cancer immunotherapy: New PD-L1 data in bladder, TNBC, renal. Six new agents entered clinic • Phase 3 starts: Lampalizumab, etrolizumab, alectinib, venetoclax and Kadcyla adjuvant • Launched next generation molecular diagnostics platform (cobas 6800/8800) M&A • InterMune: Acquisition completed • Foundation Medicine: Collaboration announced 1 CER=Constant Exchange Rates 6 2014: Continued sales growth for 4 years 10% 8% 8% 7% 6% 6% 6% 5% 5% 4% 4% 4% 2% 0% 6% 6% 4% 4% 2% 0% 0% Q1 11 Q2 11 1% Q3 11 Q4 11 Q1 12 All growth rates at Constant Exchange Rates (CER) Q2 12 Q3 12 Q4 12 Q1 13 Q2 13 Q3 13 Q4 13 Q1 14 Q2 14 Q3 14 Q4 14 7 2014: Both Divisions with sales growth in all regions CHFbn 20 +6% 18 +4% 16 +3% 14 +6% 12 +2% Diagnostics +13% 10 +6% 8 6 +6% 4 0% 2 +7% +2% Pharma +3% 0 Japan International All growth rates at Constant Exchange Rates (CER) Europe US 8 2014: Core operating profit and margin Margin at high levels 44.0% 37.7% 38.3% CHFm 37.2% (-0.1%p2) -0.5 %p1 (-1.1 %p) 1 +3 % (-1 %) 17,160 17,904 17,636 44.4% 43.6% (+0.3%p2) -0.2 %p1 (-0.8 %p) +4 %1 (-1 %) 15,488 16,108 16,001 % of sales 21.3% 20.8% 19.5% -0.9 %p1 (-1.3 %p) +2 %1 (-4 %) 2012 2013 Roche Group 1 CER=Constant 2 At 2,187 2,177 2,096 2014 Pharma Division Exchange Rates CER excluding one-time double charge for the US Branded Prescription Drug fee in 2014 Diagnostics Division 9 2014: Dividend and payout ratio further increased CHF Dividend payout ratio (%) 10,00 55,3 9,00 8,00 51,6 48,6 44,8 2014 payout ratio: 56.0% 7,00 6,00 5,00 31,9 54,7 54,5 56.0 8.00 38,8 34,5 4,00 3,00 2,00 1,00 0,00 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 Payout ratio calculated as dividend per share divided by core earnings per share (diluted); 2014 dividend as proposed by the Board of 1 compound annual growth rate Directors; Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996 2014 10 Performance update Foundation Medicine acquisition Pharma pipeline update Outlook 11 Foundation Medicine: Overview Leader in oncology molecular information Company facts • Founded 2010 in Cambridge, MA, USA FMI’s solution: A molecular information platform • Primarily VC-funded until IPO in 2013 • Core proprietary molecular information platform • Two leading solutions for comprehensive genomic profiling of cancers – FoundationOne: solid tumors – FoundationOne Heme: hematologic cancers and sarcomas 12 FMI: Clinical business Molecular information and services Physicians send samples to FMI Sample Generate Data Interpret Data Sample preparation Clinical Knowledgebase Genomic sequencing Contains sequencing data from patients and literature* Interactive patient report is sent to the oncologist Report contains treatment options including FDA-approved targeted therapies and novel treatments in development Illustrative *Also starting to contain outcomes data 13 Patient journey – FMI’s role Molecular information platform Diagnosis Comprehensive assessment of disease Oncologist decision Monitoring • Established treatment • Experimental treatment/ trial • Sustained response/cure? • Progression? FMI offering: Portal for Physicians 1 Comprehensive tests* 2 Standardized knowledgebase 3 Molecular information *Next Generation sequencing 14 1 Comprehensive tests Tissue limited and multiple modalities required Today Single assays, “tissue is the issue” Example: Lung Cancer Future Multiplex assays and Monitoring Example: Lung Cancer Comprehensive tumor analysis… Multiple modalities required including: Lung Biopsy 8-10 slides DNA & RNA sequencing Enough tissue for only 2-3 individual tests 8-10 slides Protein expression – Multiplex IHC …and continuous monitoring Produces a single snapshot Blood Imaging Illustrative 15 2 Standardized knowledgebase Enables comparability of results both in R&D and in the clinic In R&D Comparability of results essential • Comprehensive genomic profiling leads to better insights across programs: “bench to bedside to bench” Early R&D Data Clinical Trial Data • Translates to the clinic as well: – Same assay in R&D and the clinic improves confidence in results – Results comparable across centers/ hospitals Produces a powerful knowledgebase and enables faster insight generation 16 3 Molecular information platform Essential to extract insights out of large volumes of data Value for Physicians Interactive, easy to read, and meaningful report Value for Pharma customers Support in interpreting data generated via clinical trials – also prospectively for trial design and patient screening Foundation Medicine differentiated by their ability to extract insights from their knowledgebases and their partnerships with major medical centers and providers 17 Summary of FMI fit to Roche Meets urgent current needs and adds key capabilities FMI offering Value for Roche Comprehensive DNA and RNA sequencing tests that complement Roche capabilities Standardized clinical trial data captured in a knowledgebase Data analysis to provide R&D insights Potential for faster uptake of new medicines and combinations 18 Roche and FMI can innovate together Immunotherapy and continuous monitoring key areas for collaboration Future Multiplex assays and Monitoring Example: Lung Cancer Comprehensive tumor analysis… Multiple modalities required including: DNA & RNA sequencing Protein expression – Multiplex IHC 8-10 slides Key innovations that Roche and FMI can develop together: 1 RNA-based Immunotherapy test 2 Continuous monitoring of tumor specific molecular alterations in blood …and continuous monitoring Blood Imaging 19 Performance update Foundation Medicine acquisition Pharma pipeline update Outlook 20 Roche: A pipeline of differentiated products Oncology Launched Phase III Phase II Avastin Rituxan/MabThera Herceptin Xeloda Tarceva Zelboraf Erivedge Perjeta Kadcyla Gazyva/Gazyvaro Oncology Immunology/ Ophthalmology Esbriet Pulmozyme Neuroscience Ophthalmology Immunology Xolair Actemra/RoActemra Rituxan/MabThera RA Lucentis pictilisib1 taselisib1 anti-PDL1 venetoclax (Bcl2i) cobimetinib4 alectinib lampalizumab3 ocrelizumab gantenerumab 10 NMEs + 9 AIs 3 AIs 6 NMEs lebrikizumab etrolizumab2 Neuroscience Phase III decision pending; 2 FPI in 1H 2014; 3 FPI in 2H 2014; 4 Filed in combination with Zelboraf in metastatic melanoma AI = Additional Indication; NME = New Molecular Entity 1 21 HER2 franchise expected to grow further Biosimilars delayed to 2017 Est. Biosimilars launch (EU) 2nd line mBC Xeloda + lapatinib 1st line mBC Herceptin + chemo Adjuvant BC Herceptin + chemo Kadcyla (EMILIA) Herceptin & Perjeta + chemo (CLEOPATRA) Herceptin sc + chemo (HannaH) Neoadjuvant Herceptin + chemo BC (NOAH)1 2011 2012 Established standard of care Herceptin & Perjeta + chemo (APHINITY) Herceptin & Perjeta + chemo (Neosphere, Tryphaena)2 2013 2014 2015 Kadcyla & Perjeta + chemo (KRISTINE) 2016 2017 New standard of care 2018 Kadcyla (KATHERINE) Kadcyla & Perjeta (KAITLIN) 2019 2020 Potential new standard of care Key priorities in 2015 • Strengthen PERJETA as standard of care in 1L mBC & neoadjuvant, Kadcyla in 2L • Secure durable conversion from Herceptin IV to SC Clinical data in 2015 • PERJETA 2L PHEREXA final PFS & interim OS data expected Q3 15 • Release of the NEOSPHERE final PFS/DFS data at ASCO 22 Hematology franchise Extensive late stage clinical trial program Biosimilars delayed to 2017 Compound Combination* Indication P1 P2 Gazyva Mono GREEN CLL Gazyva Mono GOYA aNHL Gazyva Mono GADOLIN iNHL Gazyva Mono GALLIUM 1L FL Gazyva +PDL1 R/R FL Gazyva +PDL1 aNHL venetoclax** +Rituxan MURANO R/R CLL venetoclax +Gazyva CLL14 CLL venetoclax Mono R/R CLL 17p venetoclax +Rituxan R/R FL venetoclax +Rituxan/Gazyva 1L aNHL venetoclax +Rituxan R/R NHL venetoclax Mono R/R MM venetoclax Mono AML polatuzumab +Rituxan/Gazyva NHL polatuzumab +Gazyva R/R FL polatuzumab +Gazyva aNHL P3 * Combination(s) with branded Roche compounds ** venetoclax in collaboration with AbbVie venetoclax (Bcl2 inhibitor); polatuzumab vedotin (CD79b ADC) 23 2014 Roche cancer immunotherapy: Six NMEs moved into the clinic T cell Trafficking New in 2014 Priming & activation Anti-CEA-IL2v Anti-OX40 NME (Anti-ctyokine) T cell infiltration Anti-CD27* Anti VEGF: Avastin Antigen presentation Anti-CD40 IMA942 vaccine* Cancer T cell recognition (Immatics) Anti-CEA-CD3 Anti-HER2-TDB Antigen/T cell bispecific Mabs ImmTAC* (Immunocore) T cell killing Clinical development Preclinical development Established therapies * Partnered projects (external) Chen and Mellman. Immunity 2013 Antigen release Targeted therapies: Tarceva, cobimetinib, Zelboraf, Gazyva Anti-PD-L1 Anti-CSF-1R Anti-CEA-IL2v Anti-OX40 IDO inhibitor (NewLink Genetics) NME (undisclosed) IDO inhibitor* (Incyte) 24 Cancer immunotherapy program growing strongly Compound Combination Indication PDL1 Mono +Tarceva Lung PDL1 Mono Bladder PDL1 PDL1 Mono +Avastin +Zelboraf +Zelboraf+cobimetinib Renal Melanoma Mono +Avastin +cobimetinib +ipilimumab +IFN alfa-2b +CD40 +OX40 +CSF-R1 +CEA IL2v Solid tumors PDL1 +Avastin+FOLFOX Colorectal PDL1 Mono +Gazyva Hematology PDL1 Mono PDL1 Triple negative breast cancer CSF-1R Mono +CD40 Solid tumors CEA IL-2v Mono Solid tumors OX40 Mono Solid tumors Mono Mono Solid tumors CEA CD3 IDO Study ongoing Solid tumors Study imminent Additions since Q3 Ph 1 Ph 2 Ph 3 Status as at January 2015 25 Roche cancer immunotherapy Pipeline as of 2014 year end… Phase I Anti-PDL1+Tarceva NSCLC Anti-PDL1+Zelboraf Melanoma Anti-PDL1 Solid tumors Anti-PDL1+Avastin Solid tumors Anti-PDL1+cobimetinib Solid tumors Anti-PDL1+ipilimumab Solid tumors Anti-PDL1+IFN-alfa Solid tumors Anti-PDL1+ CD40 Solid tumors PDL1+Avastin+FOLFOX CRC Anti-PDL1 + Gazyva Blood cancer Anti-PDL1 TNBC Anti-CSF1R Solid tumors Anti-CEA IL-2v Solid tumors Status as at December 2014 Phase II Anti-PDL1 NSCLC (Dx+) Anti-PDL1 NSCLC 2/3L Anti-PDL1+Avastin Renal 1L Anti-PDL1 Bladder 1/2L Anti-OX40 Solid tumors CEA CD3 Solid tumors IDO Solid tumors Phase III Anti-PDL1 NSCLC 2/3 L Anti-PDL1 trials NMEs monotherapy Immune doublets 26 Roche cancer immunotherapy …and additional trials already decided upon Phase I Anti-PDL1+Tarceva NSCLC Anti-PDL1+Zelboraf Melanoma Anti-PDL1 Solid tumors Anti-PDL1+Avastin Solid tumors Anti-PDL1+cobimetinib Solid tumors Anti-PDL1+ipilimumab Solid tumors Anti-PDL1+IFN-alfa Solid tumors Anti-PDL1+ CD40 Solid tumors PDL1+Avastin+FOLFOX CRC Anti-PDL1 + Gazyva Blood cancer Anti-PDL1 TNBC Anti-CSF1R Solid tumors Anti-CEA IL-2v Solid tumors Status as at January 28, 2015 Phase II Anti-OX40 Solid tumors CEA CD3 Solid tumors IDO Solid tumors Anti-PDL1 + OX40** Solid tumors Anti-PDL1 + CSF1R** Solid tumors Anti-PDL1 + CEA-IL2v** Solid tumors Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1 NSCLC (Dx+) Anti-PDL1 NSCLC 2/3L Anti-PDL1+Avastin Renal 1L Anti-PDL1 Bladder 1/2L Anti-PDL1 trials NMEs monotherapy Phase III Anti-PDL1 NSCLC 2/3 L Anti-PDL1** Bladder 2L Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Anti-PDL1** tba Immune doublets 2015 readout expected ** Study start in 2015 27 ACE 910 in Hemophilia A FVIIIa NON-INHIBITOR A novel FVIIIa mimetic bispecific antibody INHIBITOR ACE 910 Kitazawa, Shima, Yoshioka, Hattori . Nature Medicine 2012;18(10):1570, Sampei, et al. PLoS One 2013;8(2):e57479, Muto, Shima, Hattori . J Thromb Haemost 2014;12:206 On-demand treatment 1-3 times/bleeding event, IV Prophylaxis 3 times/week, IV Inhibiting Factor VIII antibodies in 20-33% of the patients Immune Tolerance Induction 70-80 % success rate limitation due to very high cost and heavy burden for patients On-demand treatment with bypassing agents 2-3h intervals, IV Prophylaxis with bypassing agents Every other day, IV Mode of action Targeted product profile Novel approach promoting FX activation and acceleration of coagulation • Less frequent dosing • Subcutaneous • Avoid induction of inhibiting antibodies In collaboration with Chugai 28 Performance update Foundation Medicine acquisition Pharma pipeline update Outlook 29 2015 milestones Launch new products Expand cancer immunotherapy Renew CD20 franchise Esbriet: US and EU Cobimetinib + Zelboraf: US and EU PD-L1: Bladder, Lung, Renal, Triple Negative BC NMEs: OX40, CD40, CEA-IL2, CSF1R, IDO, CEA-CD3 Gazyva (aggressive NHL)* Entry into Hemophilia ACE910: Start of pivotal trials Entry into Multiple Sclerosis Ocrelizumab: Phase 3 readout Diagnostics * Event-driven (interim analysis) Rollout of key platforms (cobas 6800 / 8800) 30 2015 outlook 1 At 2 Group sales growth1 Low to mid-single digit Core EPS growth1 Ahead of sales growth2 Dividend outlook Further increase dividend in Swiss francs constant exchange rates Excluding sale of filgrastim rights in 2014 31 Doing now what patients need next
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