Bayer Meet Management in London on September 30, 2014
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Transcript of Bayer Meet Management in London on September 30, 2014
The New Bayer
London, September 30, 2014 / Marijn Dekkers, CEO
Page 1
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.
Page 2 • Meet Management • Marijn Dekkers • September 30, 2014
The New Bayer – Creating Value as an Innovation and Science Company
Page 3
• 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
• Meet Management • Marijn Dekkers • September 30, 2014
Animal Health Plant HealthHuman Health
HealthCare CropScience
The New Bayer –A Pure Life Science Player
Page 4
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
• Meet Management • Marijn Dekkers • September 30, 2014
The New Bayer – Setting Trends in Research-Intensive Areas of Life Science
Page 5 • Meet Management • Marijn Dekkers • September 30, 2014
Page 7
+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
• Meet Management • Marijn Dekkers • September 30, 2014
Page 8
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
One of the Fastest-Growing Global Pharma Companies
• Meet Management • Marijn Dekkers • September 30, 2014Page 10
€ 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
Plans for continued growth
Pharma Launch Products Drive Growth -Combined Peak Sales Potential of ≥€7.5bn
• Meet Management • Marijn Dekkers • September 30, 2014Page 11
€ 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
Page 12 • Meet Management • Marijn Dekkers • September 30, 2014
Plans for continued growth
Plans for continued growthAchievementsAchievements
3.4
20132010
5.5
Consumer Care Sales€ billion, 2013 pro forma
Aspiring for Crop Protection Leadership
• Meet Management • Marijn Dekkers • September 30, 2014
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
Page 13
Plans for continued growth
Plans for continued growth
New Products Drive Growth at Crop Protection
• Meet Management • Marijn Dekkers • September 30, 2014Page 14
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
• Meet Management • Marijn Dekkers • September 30, 2014Page 16
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
• Meet Management • Marijn Dekkers • September 30, 2014
Expect Continuous Flow of Products from Progressing Pharma Pipeline
Page 17*Subject to successful clinical development, filings and
regulatory approvals as planned; NME: New molecular entity
…
Up to 2 NME’s in2 years*
Up to 7 NME’s in5 years*
Up to 15 NME’s in7 years*
Regorafenib Eye Drops Could Become a Significant Advance in Treating wAMD
Page 18
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
• Meet Management • Marijn Dekkers • September 30, 2014
Copanlisib – Potential New Treatment for Patients with Non-Hodgkin’s Lymphoma
Page 19
● 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
• Meet Management • Marijn Dekkers • September 30, 2014
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
Page 20
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, 2014Page 21
Sivanto – A New Premium Insecticide for Fruit and Vegetable Growers
• Meet Management • Marijn Dekkers • September 30, 2014Page 22
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
• Meet Management • Marijn Dekkers • September 30, 2014Page 23
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
• Meet Management • Marijn Dekkers • September 30, 2014Page 24
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
• Meet Management • Marijn Dekkers • September 30, 2014Page 25
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
• Meet Management • Marijn Dekkers • September 30, 2014Page 26
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
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
––––
• Meet Management • Marijn Dekkers • September 30, 2014Page 28
HC StarckWolff Walsrode
DivestedDivested
Page 29
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
Page 30
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
• Meet Management • Marijn Dekkers • September 30, 2014
H2 2014 2015 H1 2016
Demerger of MaterialScience: Design of Planned Capital-Market Exit
Page 31
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
• Meet Management • Marijn Dekkers • September 30, 2014
The New Bayer - A World-Class Life Science Company
Page 33
• 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
• Meet Management • Marijn Dekkers • September 30, 2014
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, 2014Page 2
• 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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014Page 6
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
• Meet Management • Andreas Busch • September 30, 2014Page 7
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*
Up to 7 NME’s in 5 years*
Up to 15 NME’s in 7 years*
Milestones for the Mid-/ Late-Stage Pipeline
• Meet Management • Andreas Busch • September 30, 2014Page 9
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
*Current plan for presentation
State-of-the-Art Technology Platforms are in Place for Small Molecule Drug Discovery…
• Meet Management • Andreas Busch • September 30, 2014Page 10
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
• Meet Management • Andreas Busch • September 30, 2014Page 11
Copanlisib
Molidustat
Finerenone
Vericiguat
Vilaprisan
Add. 4 Phase II projects
18 Phase I projects
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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% **
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014Page 31
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
*Current plan for presentation
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
• Meet Management • Andreas Busch • September 30, 2014Page 32
Phase II Eye-drop formulation in wet
AMD
Peripheral artery disease (PAD) –VOYAGER PAD
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014
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
• Meet Management • Andreas Busch • September 30, 2014Page 35
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
• Meet Management • Andreas Busch • September 30, 2014Page 36
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