Investor Handout. 34 th Annual J.P. Morgan Healthcare Conference

Transcription

1 Investor Handout 34 th Annual J.P. Morgan Healthcare Conference January 2016

2 This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments. Figures for 2012 have been restated due to changes in accounting policies relating to the accounting standards IAS 19R ( Employee Benefits ) and IFRS 11 ( Joint Arrangements ). In addition, Bayer changed accounting for the stock-based compensation program. Disclaimer

3 Fast-Growing Global Pharma Business Sales billion; % yoy Fx & portfolio adj. Successful launch of 5 products +11% +9% +4% +1% Leading novel oral anti-coagulant Success in treatment of retinal diseases First-in-class -radiopharmaceutical First marketed sgc modulating agent Multi-kinase inhibitor for cancer treatment Page 1 J.P. Morgan Healthcare Conference 2016 sgc: Soluble guanylate cyclase Q3 2015: Further Growth Momentum in Pharma Sales in million % currency & portfolio adj. Launch Products in million % currency adj. EBIT before special items % yoy EBITDA before special items % yoy 3,039 3, , ,139 Q3 14 Q3 15 Q3 14 Q3 15 Q3 14 Q3 15 Q3 14 Q % +42% +24% +19% Page 2 J.P. Morgan Healthcare Conference 2016

4 Full Year 2015 Pharma Outlook Projects Further Growth and Higher Earnings Sales % Fx and portfolio adjusted Original guidance 2015 Update October Sales 12.1bn Mid-to-high-single-digit % increase ~ 13bn (positive FX effect approx. +2%) High-single-digit % increase ~ 14bn (positive FX effect approx. +5%) Launch Product Sales 2.9bn Towards 4bn > 4bn EBITDA before special items 3.7bn Low-teens % increase Mid-teens % increase Page 3 J.P. Morgan Healthcare Conference 2016 Assuming end Q3 15 Fx rates Outlook depends on specific planning assumptions as detailed in the Annual Report Strategic Priorities for Pharma Drive Growth Build Pipeline Maximize value of launch products Exploit life-cycle management opportunities Drive commercial excellence in marketing and sales Deliver real world experience data Develop robust late-stage development portfolio Advance early and mid-stage pipeline Invest in research capabilities Page 4 J.P. Morgan Healthcare Conference 2016

5 Xarelto and Eylea Drive Growth 9M 2015 sales in million; % Fx adj. Anticoagulation 1, % Ophthalmology % Hemophilia A % Contraception % Cancer % Multiple Sclerosis 634-9% Contraception 538-5% Hypertension % sec. MI Prevention Diabetes % +4% Page 5 J.P. Morgan Healthcare Conference 2016 MI: Myocardial infarction Xarelto Leading Novel Anticoagulant Sales million; % Fx adj. Global Sales Market Share* 1,679 1, % ~34% ~11% ~18% M 2015 Xarelto Pradaxa Eliquis Continued dynamic growth: gaining ~2%-age points market share since Dec 2014 >15 million patients treated to date Comprehensive Life-cycle management program underway** Peak sales potential of ~ 3.5bn reiterated Page 6 J.P. Morgan Healthcare Conference 2016 *Anticoagulant market, as of October 2015 ** in collaboration with J&J

6 Real World Studies Confirm Benefit of Xarelto in Different Indications Safety and efficacy of rivaroxaban for stroke prevention in non-valvular atrial fibrillation. (N= ~6,800) Safety and efficacy of rivaroxaban versus standard of care for acute DVT treatment (N= ~5,100) Prospective real world studies confirmed the benefit of Xarelto in routine clinical practice Safety and efficacy of rivaroxaban versus standard of care in VTE prophylaxis after major orthopaedic surgery (N= ~17,000) Page 7 J.P. Morgan Healthcare Conference 2016 Investigating New Indications for Xarelto Major phase III studies* Indication # of patients diagnosed** Primary *** completion Chronic heart failure and significant coronary artery disease Major cardiovascular events in coronary or peripheral artery disease Embolic stroke of undetermined source 3-4 million 2 Apr 2017e ~35 million 1 Feb 2018e ~2 million 2 Jan 2018e Peripheral artery disease >3 million 2 Jan 2019e Page 9 J.P. Morgan Healthcare Conference 2016 *Examples; ** Internal estimates on number of diagnosed patients (1: global; 2: EU major 5 countries +Japan + US) based on multiple published references;***as published at clinicaltrials.gov status Dec 2015 Xarelto is being developed in cooperation with Johnson & Johnson

7 Developing New Approaches in Anticoagulation via FXI Inhibition ISIS-FXI RX Antisense Drug Candidate Antisense oligonucleotide 1 that specifically reduces the biosynthesis of clotting factor XI Positive Phase II data 2 Fully human IgG Anti-FXIa Antibody 200 mg 300 mg 40 mg Preclinical studies showed Strong antithrombotic effect in standard animal models of venous & arterial thrombosis No bleeding in sensitive animal models despite high dosing & combination with antiplatelet therapy Phase I initiated Oral small molecule FXIa Inhibitor Preclinical profile confirms anti-coagulation potential with low bleeding risk Phase I initiated Page 9 J.P. Morgan Healthcare Conference ) In-licensed from Isis-Pharmaceuticals 2) Prevention of thrombosis in patients undergoing total knee arthroplasty Büller et al., NEJM (2015) 372; 232 Eylea Gaining Share in Key Markets Sales million; % Fx adj. Europe 5 main countries + Switzerland Japan % ~41% 46% >65% % M * * Significant label expansion achieved. New indications approved: DME, mcnv and RVO Life-cycle management including combination therapy with PDGFR-β antibody** Peak sales potential of 1.5bn reiterated Page 10 J.P. Morgan Healthcare Conference 2016 DME: Diabetic macula edema mcnv: Myopic choroidal neovascularization RVO Retinal vein occlusion Marketed by Bayer ex-us only *Sales market share, October 2015 **in collaboration with Regeneron

8 Eylea and PDGFR-ß Combination Therapy for wet AMD Eylea and a PDGFR-ß antibody co-formulation in wet AMD Program currently in phase II 2 PDGF-inhibition can potentially augment efficacy of VEGF-inhibition in wet AMD 1 PDGF is potentially important in the pathogenesis of wet AMD May induce maturation of pathological neovascularization through pericyte stimulation Was experimentally shown to recruit pro-fibrotic cells in the eye and may therefore have a role in retinal scarring secondary to wet AMD 3 Page 11 J.P. Morgan Healthcare Conference 2016 PDGF(R): Platelet derived growth factor (receptor) 1 Diago et al. Mayo Clin. Proc. 2008; 83, In collaboration with Regeneron 3 Kudelka et al. Exp Rev Ophthalmol. 2013; 8(5): R&D-Opportunities for Pharma Life-cycle management for launch products Progressing mid-stage pipeline Research and early pipeline Potential for: Label expansion Enhanced clinical profiles e.g. in specific patient populations Main achievements 2015: Copanlisib moved into phase III Finerenone in phase III in 2 indications Positive phase IIb data for Vericiguat Therapeutic area focus on: Cardiology / Hematology Ophthalmology Oncology others Page 12 J.P. Morgan Healthcare Conference 2016

9 Key Mid- and Late-stage Pipeline Projects Project Mode of Action Indication Status Damoctocog alpha pegol Page 13 J.P. Morgan Healthcare Conference 2016 Factor VIII Hemophilia A Phase III completed Copanlisib PI3K-Inibitor Non-Hodgkin s Lymphoma Phase III Finerenone MRA Diabetic Kidney Disease Phase III Finerenone MRA Worsening Chronic Heart Phase III Failure Vericiguat sgc-stimulator Worsening Chronic Heart Phase IIb Failure (HFrEF) Vericiguat sgc-stimulator Worsening Chronic Heart Phase IIb Failure (HFpEF) ODM-201 Androgen Receptor Non-metastatic CRPC Phase III Antagonist Molidustat HIF-PH-Inhibitor Renal Anemia Phase IIb Vilaprisan Selective Progesterone Receptor Modulator Uterine Fibroids Phase IIb HFr(p)EF: Heart failure with reduced (preserved) ejection fraction; CRPC: Castration resistant prostate cancer; MRA: Mineralocorticoid receptor antagonist PI3K: Phosphoinositide 3-kinase; sgc: Soluble guanylate cyclase HIF-PH: Hypoxia inducable factor prolyl hydroxylase Positive Phase IIb Results from Cardiology Pipeline Projects Project Mode of Action Indication Status Damoctocog alpha pegol Page 14 J.P. Morgan Healthcare Conference 2016 Factor VIII Hemophilia A Phase III completed Copanlisib PI3K-Inibitor Non-Hodgkin s Lymphoma Phase III Finerenone MRA Diabetic Kidney Disease Phase III Finerenone MRA Worsening Chronic Heart Phase III Failure Vericiguat sgc-stimulator Worsening Chronic Heart Phase IIb Failure (HFrEF) Vericiguat sgc-stimulator Worsening Chronic Heart Phase IIb Failure (HFpEF) ODM-201 Androgen Receptor Non-metastatic CRPC Phase III Antagonist Molidustat HIF-PH-Inhibitor Renal Anemia Phase IIb Vilaprisan Selective Progesterone Receptor Modulator Uterine Fibroids Phase IIb HFr(p)EF: Heart failure with reduced (preserved) ejection fraction; CRPC: Castration resistant prostate cancer; MRA: Mineralocorticoid receptor antagonist PI3K: Phosphoinositide 3-kinase; sgc: Soluble guanylate cyclase HIF-PH: Hypoxia inducable factor prolyl hydroxylase

10 Finerenone A Novel MRA in Development for Two Indications Diabetic Kidney Disease High rates of cardiovascular morbidity and mortality. Major reason for kidney failure. RAAS-inhibition (ACEi or ARB) as standard of care. No MRA approved. Finerenone targeted to be first-inclass MRA. Chronic Heart Failure Despite evolving treatment landscape, morbidity and mortality remain high. Steroidal MRAs approved and recommended in guidelines but underutilized due to side effect profile. Finerenone targeted to be best-inclass MRA for treatment of HFrEF Potential for differentiation of Finerenone from approved MRAs due to Non-steroidal chemical structure Higher receptor selectivity than Spironolactone 1 Higher potency than Eplerenone 1 Lower incidence of hyperkalaemia and worsening renal function demonstrated in PII 2 Page 15 J.P. Morgan Healthcare Conference 2016 MRA: Mineralocorticoid receptor antagonist; RAAS: Renin angiotensin aldosterone system; ACEi: Angiotensin converting enzyme inhibitor; ARB: Angiotensin receptor blocker 1) Based on in vitro data; 2) Pitt B. et al. Europ. Heart J. (2013) 34, 2453 Finerenone Phase III Program Includes Three Event-Driven Outcome Trials DKD FIGARO-DKD N~6,400 FIDELIO-DKD N~4,800 T2DM and DKD DKD with high risk of developing CV events Primary endpoint: CV death / non fatal CV events Position as first-in-class MRA in DKD T2DM and DKD DKD with high risk of progression of CKD and developing CV events Primary endpoint: Renal death / kidney failure Position as first-in-class MRA in DKD CHF FINESSE-HF N~4,700 Chronic HFrEF with T2DM and/or CKD Patients at high risk of CV mortality and morbidity Primary endpoint: CV death / CV hospitalization Target best-in-class MRA profile in HFrEF Page 16 J.P. Morgan Healthcare Conference 2016 CHF: Chronic Heart Failure; CKD: Chronic kidney disease; DKD: Diabetic kidney disease; MRA: Mineralocorticoid receptor antagonist; CV: Cardiovascular; HFrEF: Heart failure with reduced ejection fraction; T2DM: Type 2 diabetes mellitus

11 Vericiguat Targeting Treatment of Heart Failure Direct increase of cgmp level through sgc stimulation as new MoA cgmp is a critical regulator of cardiac and vascular function In heart failure, cgmp deficiency due to insufficient sgc stimulation may contribute to progressive myocardial injury and dysfunction New mode of action aims at restoration of deficient sgc-derived cgmp Holds promise to improve cardiac performance Potential reduction in morbidity and mortality on top of standard of care in heart failure Page 17 J.P. Morgan Healthcare Conference 2016 sgc, Soluble guanylate cyclase; cgmp: Cyclic guanosine monophosphate; MoA: Mode of Action Vericiguat Dose Dependently Reduced NTproBNP in Heart Failure Patients Change in log-transformed NT-proBNP Change in log-transformed NT-proBNP Placebo 1.25mgmg 2.5mg mg to 5mg to to 10mg to Pooled 5 mg 10 mg P < 0.02 P < 0.05 P = 0.15 SOCRATES Phase IIb trial in patients with HFrEF (N = 456) 1 Prim. endpoint (pooled analysis) not met 10 mg dose demonstrated greater reductions in log-transformed NT-proBNP than placebo at 12 weeks Patients randomized to 10 mg dose daily achieved: Greater improvement in left ventricular ejection fraction Numerically fewer cardiovascular deaths or HF hospitalizations Adverse events were not increased in the highest target dose arm of Vericiguat compared to placebo Page 18 J.P. Morgan Healthcare Conference 2016 HF: Heart failure; HFr(p)EF: Heart failure with reduced (preserved) ejection fraction; 1) Gheorghiade, M. et al. JAMA (2015), doi: /jama

12 Pipeline Milestones Compound Intended Indication Status Milestone Vericiguat sgc stimulator Wors. chronic heart failure Phase IIb; preserved ejection fraction Data 1H 2016e Copanlisib PI3 kinase inhibitor Non-Hodgkin s lymphoma Phase II Prim. compl. 1H 2016e Roniciclib CDK-Inhibitor Regorafenib Multikinase inhibitor Molidustat HIF-PH inhibitor Vilaprisan Selective progesterone receptor modulator Rivaroxaban Factor Xa inhibitor Small cell lung cancer Phase II Prim. compl. 1H 2016e HCC (2 nd line) Phase III Prim. compl. 1H 2016e Anemia Phase II Prim. compl. 1H 2016e Uterine fibroids Phase IIb Prim. compl. 1H 2016e Atrial fibrillation with percutaneous coronary intervention (PIONEER AF-PCI) Phase III/IV Prim. compl. 2H 2016e Page 19 J.P. Morgan Healthcare Conference 2016 Prim. compl.: Primary completion as of December 2015 HCC: Hepatocellular cancer Summary Fast growing global pharma business Growth mainly driven by launch products Xarelto, Eylea, Stivarga, Xofigo, Adempas Combined peak sales potential of 7.5 billion for launch products confirmed Promising pipeline opportunities from life-cycle management and progressing mid-stage projects Phase III transition for Finerenone in diabetic kidney disease and chronic heart failure achieved Positive phase IIb data for Vericiguat in chronic heart failure Page 20 J.P. Morgan Healthcare Conference 2016

13 Date Event Publication Thursday, February 25, 2016 Tuesday, April 26, 2016 Friday, April 29, 2016 Wednesday, July 27, 2016 Wednesday, October 26, 2016 Investor Conference Call Investor Conference Call Annual General Meeting Investor Conference Call Investor Conference Call 2015 Annual Report First Quarter 2016 Results Stockholders Newsletter Second Quarter 2016 Results Stockholders Newsletter Third Quarter 2016 Results Stockholders Newsletter Reporting Events

14 Dr. Alexander Rosar Head of Investor Relations Phone: Dr. Jürgen Beunink Phone: Judith Nestmann Phone: Peter Dahlhoff Phone: Constance Spitzer Phone: Dr. Olaf Weber Phone: Contacts