bayer meet management in london on september 30, 2014

The New Bayer

London, September 30, 2014 / Marijn Dekkers, CEO

Creating Value as an Innovation and Science Company

• Meet Management • Marijn Dekkers • September 30, 2014

DisclaimerThis presentation may contain forward-looking statements based on currentassumptions and forecasts made by Bayer Group or subgroup management.

Various known and unknown risks, uncertainties and other factors could lead tomaterial 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 areavailable on the Bayer website at www.bayer.com.

The company assumes no liability whatsoever to update these forward-lookingstatements or to conform them to future events or developments.


The New Bayer – Creating Value as an Innovation and Science Company

• Build on a track record of success in science and innovation

• Address attractive markets with high growth rates and profitability

• Exit MaterialScience high-tech polymers within next 12 to 18 months


Animal Health Plant HealthHuman Health

HealthCare CropScience

The New Bayer –A Pure Life Science Player

HealthCare

CropScience

MaterialScience

Sales Split 2013 By Subgroup*

*Excluding reconciliation

CropScience - €8.8bn sales

Chemical crop protection & biologicals #2, seeds & traits

HealthCare - €18.9bn sales

Pharmaceuticals €11.2bn,leading positions in core indications

Consumer Health €7.7bn,OTC #2, blood glucose meters #3, Animal Health #5, contrast media #1


The New Bayer – Setting Trends in Research-Intensive Areas of Life Science


Performance/Aspirations

+7%

5.34.4

Sales€ million% CAGR

+4%

18.916.9

EBITDAbefore special items€ million; % CAGR

20132010 20132010

Successfully Executing Growth Strategies in Life Science Businesses

+20%

2.21.3

Sales€ million% CAGR

+9%

8.86.8

EBITDAbefore special items€ million; % CAGR

20132010 20132010

HealthCare CropScience


Aspirations for HealthCare and CropScience

DivisionSales CAGR

(2013-2016)EBITDA margin 2016

(before special items)

HealthCare 6% ~30%

Pharma 8% ≥33%

Consumer Health* 3% ~24%

CropScience 6% 24-25%

Consumer Health aspirations will be updated to include Merck & Co. Consumer Care and Dihon Pharmaceutical Group after publication of Q4 results

*Excluding pending transactions• Meet Management • Marijn Dekkers • September 30, 2014

Deliver Profitable Growth

One of the Fastest-Growing Global Pharma Companies


€ billion; ∆% Fx & portfolio adj.

Pharma Sales

2010 2011 2012 2013 H1 2014

10.0 9.910.8 11.2+1% +4%

+9%

5.7+12%

Maximize the value of launch products

Drive commercial excellence in marketing and sales

Advance early and mid-stage pipeline

Achieve Phase III readiness for 5 projects in 2015

Explore opportunities for partnerships, open innovation and bolt-on acquisitions

Plans for continued growth


Pharma Launch Products Drive Growth -Combined Peak Sales Potential of ≥€7.5bn


€ billion

Collective Sales H1 2014 Individual Sales

2010 2011 2012 2013 2014e

0.1

723115

351

€ million

0.10.4

1.5

~2.8 32

79

Total€1.3bn

Merck & Co. Consumer Care; pending

Aspiring for OTC Leadership

Strong #2 position

Some of the world’s most recognized brands

Track record of outperforming market growth

Success in long-term brand building

Highly complementary acquisitions, incl. Merck OTC

Globalize established brands

Launch innovation pipeline

Execute Emerging Markets focus strategies

Fully realize synergy potential from acquisitions

Target strategic acquisitions and alliances



Plans for continued growthAchievementsAchievements

3.4

20132010

5.5

Consumer Care Sales€ billion, 2013 pro forma

Aspiring for Crop Protection Leadership


6.8 7.38.4 8.8

5.4

2010 2011 2012 2013 H1 2014

Strengthen portfolio through focused and integrated crop solutions

Drive commercial excellencein marketing and sales

Drive new product growth, invest in life-cycle management

Extend seeds portfolio by building business in soybeans and wheat

+11%

€ billion; ∆% Fx & portfolio adj.

+9%+12%

+9%

CropScience Sales



New Products Drive Growth at Crop Protection


1.1

1.5

1.8

2.6

2012 2013 2014e 2016e

+33%

€ billion; new products launched since 2006;∆% y-o-y, fx adj.

Insecticides

New products generated 82% of absolute sales growth at Crop Protection

Sales of New Crop Protection Products … by Segment (2013)

Fungicides

SeedGrowthHerbicides

€1.5bn

Develop New Growth

Opportunities


High Confidence in R&D Investments

25 successful Phase III clinical trials at Pharma since 2010

Strengthened brands through multiple line or product introductions in Consumer Care

Launched 30 active ingredients between 2000 and 2013 in CropScience

Initiated R&D projects that leverage synergies between human, animal and plant health

Expect R&D-to-sales ratio to increase

R&D Budget 2014 Achievements€ billion

Pharma

CropScience

1.9

0.4

0.9

Consumer Health


Expect Continuous Flow of Products from Progressing Pharma Pipeline

*Subject to successful clinical development, filings and

regulatory approvals as planned; NME: New molecular entity

…

Up to 2 NME’s in2 years*



Regorafenib Eye Drops Could Become a Significant Advance in Treating wAMD

Current standard:intravitreal injection

Project goal:topical (drops) Regorafenib inhibits VEGF* receptor

signaling, a well-established principle to treat wAMD**

Regorafenib eye drops may allow topical treatment of wAMD

Targeting non-inferior efficacy but reduced efforts, costs and logistics as well as greater convenience

Phase IIa/b initiated (completion expected early 2016)

Injection into the eye

Eye drops

*Vascular endothelial growth factor **Wet age-related macular degeneration• Meet Management • Marijn Dekkers • September 30, 2014


Copanlisib – Potential New Treatment for Patients with Non-Hodgkin’s Lymphoma

● PI3k inhibitor targeting liquid tumors

● Phase II in non-Hodgkin’s lymphomaongoing - preliminary results* encouraging:

● Significant activity shown

● Complete responses observed in several forms of NHL**

● Phase II completion expected 1H 2015

● Given positive trial results, a successful development program overall and regulatory approval, best-case scenario could see first launch as early as 2016

18FDG-PET scans of a follicular lymphoma patient with partial response

52-year-old female with FL, grade 1-2, diagnosed stage IVa

*Dreyling et al. ASH 2013; **in FL, mantle cell lymphoma, peripheral T-cell lymphoma and diffuse large B-cell lymphoma


Expect Significant Newsflow from Progressing Pharma Pipeline

*Current plan for presentation

RegorafenibMultikinase inhibitor Wet AMD (eye drops) • Phase II completion 1H 2016e tbd

FinerenoneMineralocorticoid receptor antagonist

Diabetic nephropathy • Phase IIb; compl. 2H 2014e WCN March 2015e

Wors. chronic heart failure • Phase IIb; compl. end 2014e ESC Aug/Sept 2015e

CopanlisibPI3 kinase inhibitor Non-Hodgkin’s lymphoma • Phase II completion 1H 2015e ASH Dec 2015e

VericiguatsGC stimulator Wors. chronic heart failure

• Phase IIb; reduced ejection fraction - compl. mid 2015e

AHA Nov 2015e• Phase IIb; preserved ejection

fraction - compl. mid 2015e

Damoctocog alfa pegolLong-acting FVIII Hemophilia A • Data from Phase III reported Filing 2H 2015e

ODM-201Androgen receptor antagonist

Non-metastatic castration-resistant prostate cancer • Phase III completion 2018e tbd

VilaprisanProgesterone receptor antagonist Uterine fibroids • Phase IIb; completion end 2015e Phase IIa data

at SRI March 2015e

Asset Intended Indication Status/ Expected Completion

Milestone / Data Presentation* Targeted

MolidustatHIF-PH inhibitor Anemia • Phase II completion 2H 2015e tbd

Continuous Flow of Product Innovation with Promising Potential at CropScience

Innovation

ChemicalsBiologicals

Seeds&TraitsLCM

Productslaunched

2011 - 2016*

Peak sales≥ €4bn

Execution Potential

8 Chemicals

2 Herbicides2 Fungicides2 Insecticides2 SeedGrowth

14 Seeds/traits

3 Cotton5 Canola4 Rice1 Soybean1 Wheat

2 Biologicals

1 Fungicide1 Insecticide

Seed varieties

Several hundrednew varieties in vegetables andbroad acre crops

Life-cyclemanagement

New formulations and mixtures, incl. Biologicals

*Estimated and subject to regulatory approval• Meet Management • Marijn Dekkers • September 30, 2014

Sivanto – A New Premium Insecticide for Fruit and Vegetable Growers


Significant benefits to growers quick feeding cessation effective virus vector control flexible applicability at any crop stage higher-quality produce at harvest

Outstanding safety profile

Use in fruits, vegetables and selected broad-acre crops

Resistance management by novel butenolide chemistry (flupyradifurone)

First launch in 2015*

*Planned first registrations for foliar application; SeedGrowth use planned to follow subsequently

Example: Fungicide Trifloxystrobin


2001 2003 2005 2007 2009 2011 2013

Patent expiry

Nativo brand familyOther brands

Sales

Life-Cycle Management Generates Returns Beyond Patent Expiry

Innovative mixtures with IPExamples: Fox, Stratego Yield

Efficiency gains by production process optimization

Explore product properties beyond efficacyExamples: yield, quality, abiotic stress

Develop integrated crop solutionsExample: Much More Rice

Key Activities

Building a Global Wheat Seed Business –Largest Broad-Acre Crop Worldwide


Measures Taken Planned Market Entry

• 7 wheat breeding centers operating• Acquisition of superior germplasm• Numerous alliances• Significant R&D investments

• Launch of first variety planned in 2015

• Suitable for Ukraine• Open pollinated variety• Hybrid seed varieties, providing

opportunity for both yield increase and improved yield stability, expected after 2020

Market value still small - major potential seen with productivity improvement

The Life Science Approach Promises Opportunities


World-class Life Science businesses

R&D excellence in established areas

Track record of success in bringing innovation to patients and farmers

Maintain R&D productivity and innovation leadership in existing areas and establish leading positions in new areas

Gain new perspectives and explore the Life Science approach to target breakthrough innovations that address unmet needs

What we aim to achieveWhat we aim to achieveWhat we have achievedWhat we have achieved


Similar Challenges within Human, Animal and Plant Health Can Stimulate Life Science R&DRelated challenges for human, animal and plant health* Potential for collaboration & synergies

Understand and exploit the host-microbe interaction

Bring upcoming resistances back under control

Regain control over unregulated growth

*Examples

Transforming into a Pure Life Science Company

Portfolio Evolution –Transaction Volume >€47bn Since 2004*

2003 Sales €28.6bn

HealthCare

CropScience

MaterialScience

Chemicals

Major examples only

Pro-Forma 2013 Sales €29.3bn

CropScience

HealthCareDivestitures€11bn

Acquisitions€36bn

DiagnosticsPlasma

–

+++

Merck & Co. Consumer Care**Dihon**Algeta

Conceptus Steigerwald GmbH

Teva Animal HealthSchering AG Roche OTC

++

+

++

Headcount: 115,400 Pro-forma headcount: 99,000

AgraQuestAthenix

Stoneville Cotton SeedGustafson Seed Treatment +

+++

Capital-marketexit planned

*Transaction volume: acquisitions/divestments 2004 - Aug 2014**Closing expected in H2 2014

–

–

Lanxess spin-offBayer Silicones

––––


HC StarckWolff Walsrode

DivestedDivested

2014 Acquisitions Significantly Strengthen HealthCare Portfolio

Merck Consumer Care:American OTC/CC brands

Algeta:Oncology portfolio

Creating global OTC #2

Scaling-up US businessto #1

Gaining global leadership in dermatology and GI

Entry into new categories: allergy, suncare, footcare

Full control over Xofigo

Comprehensive life-cycle management: studies in earlier settings of prostate cancer, combination studies, and other tumors

Creating leading position amongst multinationals in OTC in China

Access to lower-tier cities

Dihon Pharmaceutical Group: Chinese OTC brands

Note: Algeta closed in Mar 2014; Dihon signed in Feb 2014; Merck & Co. Consumer Care signed in May 2014• Meet Management • Marijn Dekkers • September 30, 2014

Demerger of MaterialScience: Leverage the Competitive Edge

Ability to further develop own portfolio

Autonomous funding capability

Opportunity to develop a culture fitting with the business

Tailored business processes and incentive systems

Strong fundamentals for successful operations…

Leading #1 & #2 positions in attractive, growing markets

Broad customer base

Global production network providing customer proximity

State-of-the art process technology

Significant investments in new plants during recent years

MaterialScience has the potential to deliver significant value creation as a stand-alone business

... better leveraged as a separate company


H2 2014 2015 H1 2016

Demerger of MaterialScience: Design of Planned Capital-Market Exit

Unhindered business operations safeguarded during exit preparation

• Targeted time frame for capital-market exit: 12-18 months• Timing and structure of capital-market exit option depending on future

market environment• Investment of any potential proceeds mainly in Life Science businesses/

reduction of net debt

09/18 Supervisory Board Decision -Exit MaterialScience

Preparation of pro-forma financials Design of MaterialScience New Legal carve-out

Expected first trading dayof MaterialScience New shares


Summary

The New Bayer - A World-Class Life Science Company

• One of the fastest-growing global pharma companies

• On our way to OTC leadership

• Aspiring for Crop Protection leadership

• Progressing innovation pipeline

• Setting trends in research-intensive areas in the field of human, animal and plant health

• Leveraging sales growth into value creation

• Excellence in R&D and commercialization

• Leveraging leading brands with decade-long brand equity

• Superior emerging-market presence

Leadership

Capabilities

Value


Driving R&D For Sustainable Growth at Pharma

• Meet Management • Andreas Busch • September 30, 2014Page 1

London, September 30, 2014

Andreas Busch, Head of Global Drug Discovery at Bayer HealthCare

Disclaimer

This presentation may contain forward-looking statements based on currentassumptions and forecasts made by Bayer Group or subgroup management.

Various known and unknown risks, uncertainties and other factors could lead tomaterial 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 areavailable on the Bayer website at www.bayer.com.

The company assumes no liability whatsoever to update these forward-lookingstatements or to conform them to future events or developments.


• Meet Management • Andreas Busch • September 30, 2014

R&D Strategy to Fuel Long-Term Growth of Innovation-Driven Pharma Business

Page 3

Build industry leadership in selected R&D areas

Strengthen existing capabilities, i.e. drug delivery technologies, enabling technologies such as libraries, biomarker, etc.

Explore new innovation-driven areas such as inflammation Enter therapeutic areas adjacent to current core areas

cardiology and oncology such as myeloproliferative diseases or hematopoiesis

Expand R&D in ophthalmology

Realize R&D output to sustain above market growth of the Pharma business long-term

Establish a position in new areas such as alpha emitters

Maintain R&D

Excellence

Expand R&D

Core Areas

Sustain Competitive

Growth


Track Record - 25 Successful Phase III Clinical Trials at Pharma Since 2010

Page 4

Various indications incl. treatment of deep vein thrombosis/pulmonary embolism, stroke prevention in atrial fibrillation and secondary prevention of acute coronary syndrome

Wet age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization and central retinal vein occlusion

Metastatic colorectal cancer and metastatic gastrointestinal stromal tumors

Metastatic castration-resistant prostate cancer with symptomatic bone metastases

Pulmonary arterial hypertension and chronic thromboembolicpulmonary hypertension

Radioactive iodine refractory differentiated thyroid cancer

Prophylaxis in hemophilia A: Site-specific PEGylated Factor VIII with potential for 5-/ 7-days dosing intervals

Damoctocogalfa pegol

Major examples

Long-acting rFVIII


Pharma R&D – A High Performance Engine

Page 5

Early development portfolio doubled in last 4 years now with >40 NME, thereof >20 NME projects in clinical development

Research portfolio includes >100 ongoing projects overall

Track record of a high success rate

R&D investment relative to sales below industry average

Best-in-class NCE strategy with balanced NCE/NBE portfolio

60% of new molecular entities currently in development are first-in-class compounds

Productive

Efficient

Innovative

Pharma Benchmark 2014: Comparison with 13 Other Companies


Cycle timeD4 to approval

ProductivityDevelopment Spending Per

NME Approved

SuccessLate Development Success

(Phase III, Registration)

#3 (8.7 years)

#2 ($1.4 bn)

#1 (100%, 100%)

Overall rating

#1

Cycle timeD1 to start GLP tox

ProductivityDiscovery Spending Per

NME Entering Preclinical

SuccessEarly Development

NME Success (PC, PhI, PhII)

#9 (5.3 years)

#2 ($53 m)

#2 (71%, 38%, 25%)

Overall rating

#3Discovery

Development

Bayer’s overall R&D success rates increased by 30% since 2009

R&D spending / approved NME approx. 40% below industry median

Source: R&D General Metrics Study 2014 Final Report – Bayer Healthcare, prepared by KMR group, July 17, 2014Participating Companies: Pfizer, Sanofi, Novartis, Merck, Roche, AstraZeneca, J&J, Lilly, Abbott, BMS, Takeda, BI, Bayer Healthcare, NovoNordisk

Bayer Has a Highly Productive and Efficient R&D Organization


Productivity perceived as amongst the best in industry

Delivering excess return above cost of capital*

*Ref: Schulze et al Nat Rev Drug Discov. 2014 May;13(5):331-2NTD: New therapeutic drugs

Average annual peak sales of NTDs approved 2011-2013 (USD billion)

Average annual pro-forma R&D spending 2007 - 2009 (USD billion)

Continuous Flow of Launches Planned to Sustain Long-Term Growth at Pharma

• Meet Management • Andreas Busch • September 30, 2014Page 8*Subject to successful clinical development, filings and regulatory

approvals as planned; NME: New molecular entity

…

Up to 2 NME’s in 2 years*



Milestones for the Mid-/ Late-Stage Pipeline


Asset Mechanism Status / Expected Completion

Milestone / Data Presentation* TargetedIntended Indication

Molidustat HIF-PH Inhibitor Anemia Phase II completion 2H 2015e Target congress tbd

Finerenone Mineralocorticoid Receptor Antagonist Diabetic Nephropathy Phase IIb; completion 2H

2014e WCN March 2015e

Finerenone Mineralocorticoid Receptor Antagonist Wors. Chronic Heart Failure Phase IIb; completion end

2014e ESC Aug/Sept 2015e

Copanlisib PI3-Kinase Inhibitor Non-Hodgkin‘s Lymphoma Phase II completion 1H 2015e ASH Dec 2015e

Vericiguat sGC Stimulator Wors. Chronic Heart Failure Phase IIb; reduced ejection fraction - compl. mid 2015e AHA Nov 2015e

Vericiguat sGC Stimulator Wors. Chronic Heart Failure Phase IIb; preserved ejectionfraction - compl. mid 2015e AHA Nov 2015e

Damoctocogalfa pegol Long-acting FVIII Hemophilia A Data from Phase III reported Filing 2H 2015e

Vilaprisan Progesterone Receptor Antagonist Uterine Fibroids Phase IIb; completion end

2015ePhase IIa data at SRI March 2015e

ODM-201 Androgen Receptor Antagonist

Non-Metastatic Castration-Resistant Prostate Cancer

Phase III ongoing, completion 2018e Target congress tbd


State-of-the-Art Technology Platforms are in Place for Small Molecule Drug Discovery…


Compound Collection*

Compu-tational

Chemistry

Early Toxicology

Structural Biology

Early ADME/PK

Pharmaco-phore

Informatics

High Throughput Screening*

Predictive Pharma-cology*

MedinicalChemistry*

Combina-torial

Chemistry

* highly competitive, high impact

…but Full Integration of the Technology Platforms is Key to Success

Integrated Technology Platforms Output


Copanlisib

Molidustat

Finerenone

Vericiguat

Vilaprisan

Add. 4 Phase II projects

18 Phase I projects


Cardiology –Excellence and Competitive Position

Page 12

Coagulation

Area Preclinical

Anemia

Innovation potential for patients

Novel approaches in thrombosis

Pioneering sGC modulation to target areas with high need

Consider the heterogeneicetiology of heart failure via multiple innovative pathways for tailored / personalized therapies

Fight recurrent heart diseases

Address unmet need in lung diseases and vascular aging

Phase II

Finerenone

Vericiguat

Molidustat

Part Aden A1 Agonist

Vascular Aging

ChymaseInhibitor

Vasopr. Rec.-Ant.

FXI antibody

Phase I

Peg. Adreno-medullin

Elastase-Inh.

Exciting heart failure pipeline

Attractive R&D projects in thrombosis and coagulation

Anti-Thrombotics

Heart Failure

sGC –stimul.

Plasmi-nogen-

Inhibitor


Plasminogen-Inhibition for Treatment of Rare Bleeding Disorders

Page 13

Inhibition of fibrinolysis by inhibiting plasminogen is an accepted principle to prevent bleeding

Small molecule plasminogen inhibitor currently in preclinical testing for oral administration

Potential target indications include hemophilia, vWD, platelet function disorders, FXI deficiency

Initiation of phase I expected in Q1 2015

tPA: Tissue plasminogen activatorvWD: von Willebrand disease

Characteristics TranexamicAcid

BAY

Frequency of dosing 3-4 times/day once a day

Estimated dose ~10 g <0.5 g

Potency (KD) 660 nM <10 nM

Clot stability 90% lysis* 2% lysis*

Inhibition of fibrinolysis stabilizes clots Fragile clots of patients with bleeding

disorders remain in place until healing occurs Plasminogen-deficiency is not thrombogenic

BAYPlasminPlasmino-

gen

Fibrin clottPA

endothelium

*4 hours after p.o. administration of 30mg/kg p.o. to rats


Anti-FXIa Antibody Developed for Anti-Coagulation Therapy

Page 14

Inhibition of FXIa has potential for anti-thrombotic therapy without increased bleeding FXI deficiency is associated with a reduced

incidence of Ischemic Stroke and DVT

BAY1213790 is a fully-human IgG1 antibody

Preclinical studies showed Strong antithrombotic effect in standard

animal models of venous & arterial thrombosis

No bleeding in sensitive animal models despite overdosing & combination with antiplatelet therapy

Phase I initiated

ASA ASA ASA ASA ASA ASA

BAY1213790

Thro

mbu

s w

eigh

t [m

g]

20

10

0

Blee

ding

tim

e [s

]

ASA ASA ASA ASA ASA ASA

BAY1213790

200

400

Preclinical data (Rabbit Model)

Ctrl 0.1 0.3 1 3 10

Ctrl 0.1 0.3 1 3 10 mg/kg

mg/kg

ASA: Acetylsalicylic acidDVT: Deep vein thrombosis


Chymase-Inhibition – Anti-Remodeling to Improve Cardiac Function Post MI

Page 15

Myocardialinfarction

Manifestation of LVD

Mast cell activation and release of Chymasein damaged tissue

Fibrosis and structural remodeling

CHYMASE INHIBITOR

Chymase is a multi-functional local mediator of tissue remodelling with a role in the pathogenesis of LVD after AMI

Significant medical need for innovation: 1.4m patients are suffering from an

acute complicated MI per year

30% of these patients develop LVD despite treatment with standard of care*

BAY1142524 is the only chymaseinhibitor in development for the treatment of cardiovascular diseases

LVD: Left ventricular disease; AMI: Acute myocardial infarctionMI: Myocardial infarction

* Angiotensin-converting enzyme (ACE) inhibitors; Angiotensin II receptor blockers (ARB), diuretics, beta blockers, mineralocorticoid antagonists


BAY 1142524 – Convincing Preclinical Profile Supports Clinical Development

Page 16

Inhibition of pro-fibrotic pathways in vitro and in vivo

Anti-remodeling effects translate into improvement of heart function without reduction of blood pressure

Further improvement of heart function on top of ACEi and ARB demonstrated

Target indication for clinical development: treatment of patients with LVD following AMI to reduce morbidity and mortality on top of SoC

Phase I ongoing, results expected in 2H 2014

ACEi: Angiotensin-converting enzyme inhibitors; ARB: Angiotensin II receptor blockers LVD: Left ventricular disease, AMI: Acute myocardial infarction; SoC: Standard of care

mean ± SEM, n=4*,**, p < 0.05, 0.01,vs. baseline;§,§§,

p < 0.05, 0.01, 0.001 vs. placebo

BAY 1142524 5 mg/kg BID

Placebo

BAY 1142524 2 mg/kg BIDBAY 1142524 0.5 mg/kg BID

Baseline 6 weeks 12 weeks

Improvement of cardiac function in dogs with LVD

Treatment


Partial Adenosine A1 Receptor Agonists - A Novel Approach for Cardiovascular Therapies

Page 17

Activation of myocardial A1 receptors is an important inhibitor of myocardial pathologies

Adenosine elicits cardio protection through A1-receptor activation Full A1 receptor agonists induce a

broad physiologic spectrum of cardiac and extra-cardiac effects, which may result in undesired side effects

Undesired effects of full A1 agonists may be overcome by partial A1 agonists

Potential therapeutic options include treatment of heart failure, angina pectoris, ischemic injury during an acute coronary syndrome


BAY 1067197 - First-in-Class Approach for Treatment of Worsening Chronic Heart Failure

Page 18wCHF: Worsening chronic heart failure; HFrEF: heart failure with reduced

ejection fraction

Heart Failure Dog Model

Effects of BAY 1067197 on rel. increase of ejection fraction in HF dog vs. pre-treatment. Historical study with control, ß-blocker (metropolol) und ACEI (enalapril) published in Sabbah et al. (1994)

Complementing the wCHF R&D portfolio with a novel, differentiated mechanism

BAY 1067197 is an oral non-nucleosidicpartial A1 receptor agonist Preclinical data: Fast improvement of

cardiac function; prevention of progressive remodeling

Phase IIa in HFrEF ongoing – results expected end 2014 / early 2015 Upside potential in broader HF spectrum

New mode of action: option for substantial improvement “on top of SOC”

Potential for faster therapeutic effect vs. SoC


Building a Leading Portfolio of Gynecological Therapies

Page 19

Novel and differentiated approaches

AKR13C Inh.. PLRL Antag. Vilaprisan

Pathomechanism Phase IIPhase IPreclinical Innovation potential for patients

Bayer is already a leading company in Women’s HealthCare

R&D focus is on gynecological therapies: endometriosis and uterine fibroids

Significant expertise built in house

Synergies with oncology R&D

Inflammatory painSignaling pathwaysAdhesion etc.

AI&P IVR


BAY 1128688 – An AKR1C3 Inhibitor Developed for the Treatment of Endometriosis

Page 20

Endometriosis affects 5-10% of pre-menopausal women

Current treatment approaches include surgery and medical therapies (mainly sex-hormonal approaches)

AKR1C3 Inhibition is a novel non-sex-hormonal approach Potential clinical differentiators include

absent impact on the natural cycle

Phase I with AKR1C3 inhibitor BAY 1128688 initiated

Data expected end 2014

BAY 1128688 is active in a marmoset endometriosis model

Total ratio (lesion size post/ pre-treatment at bladder and uterus) in marmosets

01

23

45

Rat

io T

otal

Les

ion

Siz

e (p

ost/p

re)

Vehicle 0.2mg/kg 0.8mg/kg

-

RatioVehicle0.2mg/kg0.8mg/kggeom. mean

AKR1C3 –inhibition addresses endometriosis in two ways:A) Inhibition of local estradiol productionB) Reduction of inflammation / proliferation via

modulation of the prostaglandin pattern

AKR1C3: Aldoketoreductase 1C3


Oncology –Significant Innovation Potential

Page 21* Compounds ONCOMED property – ongoing collaboration; CDK: Cyclin dependent kinase;

PI3K: Phospharidylinositol-3 kinase; i: Inhibitor; ADC: Antibody – drug-conjugate; PSMA: Prostate-specific membrane antigen

Differentiated molecule

Novel approach

ADC’s and Thorium-platform

Hypoxia

Survival signaling

Cell cycle

Chromatin Modulation

Roniciclib

Anetumab-Ravansine

PI3K-I

Refametinib

FGFR-moAb

Pathomechanism Phase IIPhase IPreclinical

Copanlisib

CSC/Wnt-Pathway Vantictumab*

Tumor Metabolism

Immunotherapy

AKT-I.Pan-FGFR-I.

pTEFb-I

MPS1-I.

C4.4a-ADC

Innovation potential for patients

Increased efficacy alone or in combination in patients with activated pathway(s) identified by biomarkers

Increased efficacy in combination with standard cytotoxics in resistant / hard-to-treat tumor types

Increased efficacy in patients with high antigen expression on tumor

Targeting and activating immune cells as tumor-independent approach

Delay or overcome intrinsic or acquired resistance from radio-, anti-VEGF and chemotherapies

Inhibition of aberrant transcription & potentialreactivation of tumor-suppressing genes

Increase efficacy in mono- or in combination therapy in patients with solid or liquid tumors with tumor metabolism changes (biomarker driven)

Prevent/delay recurrence after initial therapy

Ipafricept*

PSMABiTE

enzalutamide 19%*

ARN-509 29%*

ODM-201 +main metabolite 3% **


ODM-201 – Strengthening Bayer’s Prostate Cancer Franchise

Page 22

ODM-201 is an AR antagonist in development in non-metastatic CRPC

M0 prostate cancer market: no approved therapies

Unique profile including Promising phase II results

Low likelihood for brain entry demonstrated in preclinical models

No CYP inhibition or induction expected with therapeutic doses

In-licensed from Orion

Phase III ongoing

AR: Androgen receptor; CRPC: Castration-rsistant prostate cancer;WT: wild-type; VCaP: a prostate cancer cell line; CYP: Cytochrome P

*Refs. Clegg et al, Cancer Research 2012; Forster at al, Prostate 2011; ** Rat autoradiography (QWBA) confirms brain/plasma ratio of 14C-ODM-201 related radioactivity was 0.04-0.06, indicating negligible penetration to the brain; profile published at ECC2013 poster E17-2119

ODM-201 has a unique preclinical profile

Compound AR affinityKi (nM)

AntagonismWT AR

IC50 (nM)

ProliferationVCaP

IC50 (nM)

enzalutamide 78 155 400

ARN-509 53 168 300

ODM-201 9 65 500

ORM-15341 (main metabolite) 8 25 600


Roniciclib (BAY 1000394) – pan-CDK Inhibitor Developed for SCLC

Page 23

CDK’s are key drivers of cell division cycle

“transcriptional” CDK’s control gene transcription

Roniciclib is an oral pan-CDK inhibitor with potent and broad preclinical antitumor activity Strong synergy in combination with

chemotherapy in SCLC models

Active in models resistant to chemotherapy

Positive phase I clinical data

S

G1

MG2

CDK1

CDK1

CDK4/6

CDK2CDK2

Roniciclib

Roniciclib

Roniciclib

Roniciclib acts in 2 ways:A) Cell-cycle inhibition

B) Survival signaling, transcriptional regulation

CDK9 CDK7

transcription, cell survival

Roniciclib

CDK: Cyclin-dependent kinase; SCLC: Small cell lung cancer


Roniciclib (BAY 1000394) – pan-CDK Inhibitor Developed for SCLC

Page 24

Positive phase I clinical data On average, patients with stable

disease (SD) stayed on treatment for 103.5 days (4-9 cycles)

Disease control rates were 29% (n=9/31) for SCLC, 36% for OC (n=9/25), and 33.3% for patients harboring tumor-specific mutations (n=2/6)

Majority of AE’s were grade 1 or 2

Phase II ongoing – completion expected end 2015

Promising Phase I clinical data

SCLC: Small cell lung cancer; OC: Ovarian cancer;AE: Adverse event

Duration of roniciclib treatment in individual patients by treatment groups


Anetumab Ravtansine – A Novel Targeted Antibody-Drug-Conjugate Therapy for Cancer

Page 25

Mesothelin, an internalizing antigen, is overexpressed by a number of solid tumors, including

mesotheliomas (100%)

pancreatic cancer (~80-100%) and

ovarian adenocarcinomas (~80%)

Anetumab ravtansine (BAY 94-9343; mesothelin-ADC) is an antibody-drug conjugate (a monoclonal antibody directed against mesothelin coupled to a linker with the cytotoxic agent DM4)

Selectivity is achieved through specific binding to the mesothelin-expressing cancer cell

Phase Ib is ongoing

Anetumab ravtansine

Immunohistology – mesothelin over-expression

DM4: Maytansine derivative


Anetumab Ravtansine –First Data from Clinical Phase I

Page 26*Bendell et al; AACR, Washington, April 6-10, 2013

MTD: Maximally tolerated dose

Phase I, single-agent, dose-escalation study* Promising signals of clinical activity

including 1 confirmed partial response

Generally well tolerated at doses up to and including 6.5 mg/kg (MTD)

Gr. 3/4 toxicities at 7.5 mg/kg dose

Phase Ib is ongoing; completion 1H 2015e

Confirmed Partial Response

71-year-old Caucasian male mesothelioma patient enrolled at 6.5 mg/kg

Total tumor thickness decreased 33% at end of cycle 2 and 36% end of cycle 4 compared to baseline tumor measurement


BAY 1179470 - A Novel FGFR2 Antibody for the Treatment of Cancer

Page 27

FGFR2 is a transmembrane tyrosine kinase - involved in embryogenesis, tissue repair and cancer

BAY 1179470 is an FGFR2-specific antibody BAY 1179470 exhibits a unique mode of

action, i.e. it induces FGFR2 internalization and degradation leading to the inhibition of downstream signaling

Encouraging preclinical profile shows potential for differentiation vs. existing standard of care incl. combination

Phase I study ongoing – data expected mid 2015Tumor growth

Metastasis

BAY

117

9470

-bin

ding

lead

ing

to:

FGFR

inte

rnal

izat

ion

and

degr

adat

ion

FRS

PLC

AKT ERK

FGFR: Fibroblast growth factor receptor

• Meet Management • Andreas Busch • September 30, 2014Page 28FGFR: Fibroblast growth factor receptor

Tumor - Model SNU-16 GC10-0608 NCI-N87 GC12-0811 MKN-45

FGFR2 IHC score 3 2 1 1 0

FGFR2 IHC

Efficacy [T/C] 0.13* 0.57* 0.66 0.78* 1.16

*p<0.05 vs vehicle control

PDx models GC10-0608, GC12-0811 performed by Professor Huynh Hung NCC, SingaporeRef: Kopitz AACR 2014

Higher antitumor activity of BAY 1179470 in gastric cancer models with FGFR2 overexpression

FGFR2 IHC presents a potential selection biomarker

IHC, immunohistochemistryT/C: Treated group over control

BAY 1179470 - Preclinical Efficacy Correlates with FGFR2 Expression


Targeted Thorium Conjugates – Expanding the Alpha-Pharmaceuticals Platform

Alpha particle emitter - high energy, heavy charged particle Half-life 18.7 days - suitable for tumor

delivery by mAbs

Significant efficacy demonstrated in preclinical model

Next steps initiated to explore Thorium platform in solid tumors: Antibodies against Mesothelin and

FGFR2 available

Fast proof of concept targeted - start of Phase I study for -CD22 Th-227 conjugate planned early 2015

+ Th-227

For all surviving animals no tumors were found on dissection

Animals treated 5 days after inoculation of HL60 (AML)

Perc

ent s

urvi

val

CB17 SCID

Statistical Analysis

(Mantel-Cox test)

< 0.0001 (****)

Preclinical disseminated AML tumor model

Page 29


Bayer’s Approach and Activities in Immuno-Oncology

Page 30

Bayer is building up a Cancer Immunotherapy portfolio based on in-house capabilities and focused collaborations:

1. Collaboration on BiTEs with Micromet/Amgen Research Munich

Phase I with PSMA-BiTE BAY 2010112 ongoing

Collaboration on a second BiTE (undisclosed target) ongoing

2. Strategic Alliance with the German Cancer Research Center

Joint laboratory expected to deliver first pre-clinical development candidates end of 2014

3. Collaboration on novel immune checkpoint regulators with Compugen

Antibody-based modulators on two novel immune checkpoints: CGEN-15001T and CGEN-15022 - two novel B7-like proteins thought to be involved in regulation of the immune system in immune-related disorders and in cancer


Data on Early Pipeline Progress Expected 2014-2016

Asset Mechanism MilestoneIntended Indication

BAY 1142524 Chymase Inhibitor Heart Failure Ph I Completion 2H 2014e

BAY 1128688 AKR1C3 Inhibitor Endometriosis Ph I Completion end 2014e

BAY 1067197 part. A1 Agonist Worsening Chronic Heart Failure

Ph IIa Completion end 2014e / early 2015

AnetumabRavtansine Antibody-Drug Conjugate Cancer Target presentation* of Ph I data

at AACR 2016

BAY 1179470 FGFR2-Antibody Cancer Target presentation* of Ph I data at ASCO 2015 / ESMO 2015

BAY 2010112 BiTE Prostate Cancer Target presentation* of Ph I data at AACR 2016

Roniciclib Pan-CDK Inhibitor Small Cell Lung Cancer Target presentation* of Ph II data at ESMO 2016


Expanding Life-Cycle Management Programs for Recently Launched Products

This slide provides a selection of studies

Major Adverse Cardiac Events:

Chronic Heart Failure:

Percutaneous Coronary

Intervention:

Atrial Fibrillation Percutaneous

Coronary Intervention:

Embolic Stroke due to unknown sources – NAVIGATE ESUS

PHIII VIVID-EAST

Polypoidal ChoroidalVasculopathy -

PLANET

Phase III combination study in metastatic

prostate cancer

Phase II combination study in metastatic

breast cancer

Repeat dosing/higher dose in CRPC

Phase I/II studies in additional cancer

types

Phase III in Colorectal Cancer

post metastasectomy

Phase III in Liver Cancer 2nd line

Phase I combination studies to support

programs in various cancer types

Phase IIb in PH¹ with Idiopathic Interstitial

Pneumonia

Phase IIb in Diffuse Systemic Sclerosis

RESPITE: Phase IIIB in PAH patients who did not respond top

PDE5-inhibitors

Signal-generating studies in Raynaud’s

phenomenon and Cycstic Fibrosis

Combination with PDGFR antibody

Phase II Exe-drop formulation in wet

AMD


Phase II Eye-drop formulation in wet

AMD

Peripheral artery disease (PAD) –VOYAGER PAD


Regorafenib – Potential for Changing the Way wAMD is Treated

Page 33

Regorafenib inhibits VEGF receptor signaling, a well established principle to treat wAMD

Regorafenib Eye drops may offer topical treatment of wAMD - targeting superior convenience but non-inferior efficacy

Phase I completed

Phase IIa/b initiated Comparator: Lucentis

Target enrollment: N=540 patients

Completion expected early 2016

Current Standard:intravitreal inj.

Project Goal:topical (drops)

Today’s standard of care is administered by injection into the eye

Eye drops could reduce efforts, costs, logistics and would be more convenient

wAMD: Wet age-related macular degeneration


Regorafenib Eye Drops – Convincing Preclinical Activity Demonstrated

Page 34

Vehicle

Regorafenib

Grade IV lesion(examples)

Rep

rese

ntat

ive

reco

rdin

gs

Regorafenib eye drops significantly reduces grade IV lesions in primates

Laser-induced CNV in primates %

grad

eIV

l esi

ons

day

21

0

10

20

30

Vehicle RegorafenibEye Drops

P<0.05

Data shown as mean ± sem.Statistics: Mann-Whitney tests on raw data

CNV: Choroidal neovascularization


Data on Life Cycle Management Projects Expected 2014-2016

*primary completion estimates as published at clincialtrials.gov as of September 2014

Riociguat

Amikacininhale

Regorafenib

Rivaroxaban

Ra-223

Asset Mechanism Milestone

sGC Stimulator

Inhaled Antibiotic

Multi-kinase Inhibitor

Factor Xa Inhibitor

Alpha Pharmaceutical

Intended Indication

Diffuse Systemic Sclerosis

Adjunctive Therapy; Intubated / Mech. Ventilated Patients with Gram-neg Pneumonia

2nd line HCC

Embolic Stroke due to Unknown Sources

Bone Metastases in Breast Cancer

Start phase IIb 2H 2014e

Completion* phase III 1H 2016e

Completion* phase III (RESORCE) 1H 2016e

Start Phase III NAVIGATE ESUS, VOYAGER PAD and PHII in ACS 1H 2015e

Start phase II in Q4 2014e

Regorafenib Multi-kinase Inhibitor Wet AMD Completion* phase IIa/b 1H 2016e


Summary: R&D To Sustain Above-Market Growth at Pharma

Execute comprehensive life-cycle management program on 5 recently launched products to support ≥€7.5bn peak sales potential

World-class LCM

Plan to launch* up to 2 NME in next 2 years, up to 7 in next 5 years, and up to 15 in next 7 years

Assets include* Finerenone, Vericiguat, Molidustat, Copanlisib, Damoctocog alfa pegol, ODM-201

Numerous NME’s planned to be

launched mid-term*

Expand research areas and increase value output

Drive internal pipeline opportunities

Complement pipeline through in-licensing

Fueling the early pipeline

Driving sustainable growth above marketNME: New molecular entity; *subject to successful clinical development, filings

and regulatory approvals as planned

bayer meet management in london on september 30, 2014

Investor Relations

meet management marijn

subgroup management

sales drive new product

lifecycle management

sales cagr2013

absolutesales growth

bncollective sales h1

new bayerlondon