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Roche: Oppenheimer 23rd Annual Healthcare Conference Thomas Kudsk Larsen, Head of Investor Relations North America, New York, 12 December 2012 Forward-looking statements 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 website2 www.roche.com. All mentioned trademarks are legally protected. Current performance Strategic positioning Summary; questions YTD Sept 2012: Highlights Strong sales growth Sales on track for full year target • Pharma, Diagnostics and Group: +4%1 Pipeline newsflow supporting long-term growth • T-DM1 shows OS benefit (EMILIA); filed in US and EU • MEKi in combination with Zelboraf to start phIII • Aleglitazar clinical program to be expanded (AlePrevent and AleGlucose) • On track to deliver LIP targets for 2012 Outlook confirmed • Low to mid single-digit sales growth1 for Pharma and the Group, above market growth for Diagnostics • Core EPS growth target ‘high single-digit’1 • Attractive dividend policy 4 1 at Constant Exchange Rates YTD Sept 2012: Group sales Supporting full-year target 2012 2011 change in % CHF bn CHF bn CHF CER Pharmaceuticals Division 26.2 24.4 +7 +4 Diagnostics Division 7.5 7.1 +6 +4 Roche Group 33.7 31.5 +7 +4 5 CER=Constant Exchange Rates Group sales growth1 Improving performance 8% 6% 6% 4% 4% 4% 2% 2% 1% 0% 0% 0% -2% -3% -4% -5% -6% Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 '10 '10 '11 '11 '11 '11 '12 '12 '12 6 1 at CER=Constant Exchange Rates Regional performance: US and Emerging markets strongly contribute to sales growth Asia- Asia 16% China driving growth in both divisions 14% Pacific Latin 12% Latin Strong demand in major markets America America 14% CEMAI 12% Pharma: driven by Middle East and N. Africa North Pharma: strong growth for strategic products US 6% 2% America Dia: strong growth in IVD lab business Japan 1% Japan 7% Recovery after earthquake; biennial price cuts Pharma: impact of generic products WE-2% EMEA -1% Dia: price pressure in Diabetes Care Pharma Diagnostics 7 CER (Constant Exchange Rates) growth rates CEMAI=Central & Eastern Europe, Central Asia, Middle East, Africa and Indian subcontinent; EMEA: Europe, Middle East and Africa. Accounts receivable in Southern Europe Reduction of 22% vs. Dec 2011 due to Spain, Italy and Portugal Sep 2012 211 Greece Dec 2011 CCC 194 152 Portugal BB 172 704 Italy 805 BBB+ 506 Spain BBB+ 850 -22% Southern European 1,573 Countries 2,021 0 500 1'000 1'500 2'000 2'500 EUR m 8 Sovereign country ratings from Standard & Poor’s, as of 5 October 2012 Increase in operating profit & margin Group core operating profit (CHF bn) and margin 38.5% 37.2% 38.1% 34.7% 35.0% +7% at CER 8.64 9.16 8.40 8.25 7.63 HY 2008 HY 2009 HY 2010 HY 2011 HY 2012 9 CER=Constant Exchange Rates HY 2012: +8% Core EPS growth1 +8% at CER CHF 6.94 6.95 6.68 6.36 5.75 HY 2008 HY 2009 HY 2010 HY 2011 HY 2012 10 1 CER=Constant Exchange Rates Outlook for 2012 confirmed Sales growth (CER) Group & Pharma: low to mid single-digit Diagnostics: above market Operational Excellence savings 2012+: CHF 2.4 bn* Core EPS growth target High single-digit (CER) Dividend outlook Continue attractive dividend policy 11 Barring unforeseen events; CER=Constant Exchange Rates; * vs. 2011: CHF 1.8 bn Current performance Strategic positioning Summary; questions Roche strategy: Focused on medically differentiated therapies Regulators: Pharma Dia Optimised benefit / risk ratio Payors: Focus Optimised benefit / cost ratio MedTech Premium for innovation OTC Generics Differentiation 13 Implications of R&D productivity challenge Segregation will continue as only true innovation will be rewarded High differentiation True innovators ‘Me-too’ players ?? Generics Medical differentiation No / limited differentiation low high low Willingness to pay for added value high 14 Roche Diagnostics enables PHC Accelerating Companion Diagnostics (CDx) projects 15 compounds with CDx in Ph 2 & 3 Collaborations within Roche Group1 >200 169 101 70 38 25 10 2005 2006 2007 2008 2009 2010 2011 15 1 Including R&D collaborations and CDx projects Importance of Personalised Healthcare Majority of our pipeline with Companion Diagnostics lebrikizumab rontalizumab EGFR ADCC Zelboraf MEK 0973* Mab (GA 201) Bcl-2-sel inh onartuzumab Perjeta bitopertin (MetMAb) danoprevir etrolizumab obinutuzumab Erivedge T-DM1 (GA101) ocrelizumab aleglitazar mericitabine anti-PCSK9 2011 2012 2013 2014 2015 2016 Post 2016 Late Stage Pipeline: 11 out of 18 compounds are targeted therapies for selected patients 16 *MEK considered as PHC in combination with Zelboraf for metastatic melanoma Expanding into selected therapeutic franchises LIP candidates 2012 target: 3 out of 5 Larger (> 1 bn) Smaller (up to ~1 bn) GA101 Perjeta T-DM1 bitopertin aleglitazar danoprevir MEK 0973 etrolizumab anti-PCSK9 ocrelizumab mericitabine lebrikizumab onartuzumab rontalizumab Bcl-2-sel inh Potential Filing 2012 2013 2014 2015 2016/17 2017 onwards Year Oncology Neuroscience Metabolism Virology Immunology 17 Non risk-adjusted Late stage pipeline Potential phase II / LIP read outs Number of NMEs Oncology Neuroscience 10 Metabolism setrobuvir Virology mGluR2 antagonist Immunology mGluR5 antagonist Ophthalmology crenezumab 5 gantenerumab anti-PCSK9 anti factor D rontalizumab anti-EGFL7 etrolizumab EGFR ADCC Mab (GA201) MEK 0973 PI3 kinase inhibitor Bcl-2-sel inhibitor Dual PI3k/ mTor inh. 2012 2013 18 LIP=Lifecycle Investment Point International region overview Eastern Europe & Middle East Asia Pacific Africa Latin America Market drivers Market barriers • Increasing investment in healthcare • Pricing pressure and controls • Life style changes and the emergence of • High out of pocket costs “western” diseases • Delays in registration and • Emergence of alternative funding models reimbursement in some markets 19 International region Increasing importance for Roche International region as proportion of total Pharma sales 28% 27% 27% 26% 25% 24% 23% 22% HY '08 FY '08 HY '09 FY '09 HY '10 FY '10 HY '11 FY '11 HY '12 20 E7 countries Strong growth in key emerging markets 1000 +79% India 800 -6% Russia +54% Korea +14% Turkey 600 -3% Mexico 400 +37% China 200 +25% Brazil 0 Q1 '11 Q2 '11 Q3 '11 Q4 '11 Q1 '12 Q2 '12 21 1 CER=Constant Exchange Rates; absolute values in CHF m at average 2011 exchange rates The P&L reflects Roche’s innovation based strategy Low on Marketing, General and Administration R&D % sales Core operating profit margin Eli Lilly 21% % sales Amgen 20% Roche 19% Pfizer 43% BMS 18% Merck 17% Astra 39% Novartis 16% Astra 15% Amgen 37% Sanofi 14% GSK 14% Roche 36% Pfizer 13% Abbott 10% Sanofi 34% Bayer 8% Merck 34% M&D+G&A % sales Eli Lilly 33% BMS 33% Novartis 32% Pfizer 29% GSK 31% Bayer 29% Merck 29% Novartis 27% GSK 29% Astra 28% Eli Lilly 27% Abbott 26% BMS 24% Abbott 23% Sanofi 24% Roche 23% Bayer 17% Amgen 18% 22 Source: Company reports, Roche analysis; Figures based on fiscal year 2011 financials High operating free cash flow and margin Group operating free cash flow (CHF bn) and margin 31.6% 32.0% 28.2% 26.1% +7% at CER 21.8% 7.17 6.78 6.86 6.43 4.81 HY 2008 HY 2009 HY 2010 HY 2011 HY 2012 23 CER=Constant Exchange Rates Aiming for a sustainable net debt leverage of 0-15% S&P rating AAA J&J AA+ Pfizer Merck Roche AA Takeda Abbott AZ Sanofi AA- Eli Lilly Novartis 2011 2010 BMS A+ Amgen Becton D GSK (25%) (31%) A Gilead Bayer A- Biogen BBB+ BBB BBB- BB+ -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 Leverage1 (%) 24 1 Net Debt / Total Assets (%); 2011 figures for all companies except Roche; Company reports; Bloomberg (June 14; 2012) Continuous increase in dividends and pay-out ratio historically Dividend per 2011 Dividend share (CHF) Payout ratio yield (%) 8 of 55.3% 6% 6.80 6.60 5% 6.00 6 5.00 4% 4.60 4 3% 3.40 2.50 2% 2.00 2 1.65 1.45 1.30 1.15 1.00 1% 0.75 0.83 0.87 0.55 0.64 0.37 0.48 0.18 0.20 0.28 0 0% '89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 25 Pay-out ratio calculated as dividend per share divided by core earnings per share (diluted) Current performance Strategic positioning Summary; questions Roche in brief Innovation & productivity • Focused innovation strategy – Personalized Healthcare through Pharmaceuticals & Diagnostics – Medically-differentiated products & services • Leading businesses – Biotech-based leadership in Oncology, Infectious disease; emerging Immunology, Cardio-metabolic and Neuroscience franchises.
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  • Microbiota and Drug Response in Inflammatory Bowel Disease

    Microbiota and Drug Response in Inflammatory Bowel Disease

    pathogens Review Microbiota and Drug Response in Inflammatory Bowel Disease Martina Franzin 1,† , Katja Stefanˇciˇc 2,† , Marianna Lucafò 3, Giuliana Decorti 1,3,* and Gabriele Stocco 2 1 Department of Medicine, Surgery and Health Sciences, University of Trieste, 34127 Trieste, Italy; [email protected] 2 Department of Life Sciences, University of Trieste, 34127 Trieste, Italy; [email protected] (K.S.); [email protected] (G.S.) 3 Institute for Maternal and Child Health—IRCCS “Burlo Garofolo”, 34137 Trieste, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-3785362 † The authors contributed equally to the manuscript. Abstract: A mutualistic relationship between the composition, function and activity of the gut microbiota (GM) and the host exists, and the alteration of GM, sometimes referred as dysbiosis, is involved in various immune-mediated diseases, including inflammatory bowel disease (IBD). Accumulating evidence suggests that the GM is able to influence the efficacy of the pharmacological therapy of IBD and to predict whether individuals will respond to treatment. Additionally, the drugs used to treat IBD can modualate the microbial composition. The review aims to investigate the impact of the GM on the pharmacological therapy of IBD and vice versa. The GM resulted in an increase or decrease in therapeutic responses to treatment, but also to biotransform drugs to toxic metabolites. In particular, the baseline GM composition can help to predict if patients will respond to the IBD treatment with biologic drugs. On the other hand, drugs can affect the GM by incrementing or reducing its diversity and richness. Therefore, the relationship between the GM and drugs used in Citation: Franzin, M.; Stefanˇciˇc,K.; the treatment of IBD can be either beneficial or disadvantageous.