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Meet Management in Cologne – September 20, 2016
Werner Baumann, CEO of Bayer AG
Investor Presentation - Group
Certain statements contained in this communication may constitute “forward-looking statements.” Actual results could differ
materially from those projected or forecast in the forward-looking statements. The factors that could cause actual results to
differ materially include the following: the risk that Monsanto Company’s (“Monsanto”) stockholders do not approve the
transaction; uncertainties as to the timing of the transaction; the possibility that the parties may be unable to achieve
expected synergies and operating efficiencies in the merger within the expected timeframes or at all and to successfully
integrate Monsanto’s operations into those of Bayer Aktiengesellschaft (“Bayer”); such integration may be more difficult, time-
consuming or costly than expected; revenues following the transaction may be lower than expected; operating costs,
customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees,
customers, clients or suppliers) may be greater than expected following the transaction; the retention of certain key
employees at Monsanto; risks associated with the disruption of management’s attention from ongoing business operations
due to the transaction; the conditions to the completion of the transaction may not be satisfied, or the regulatory approvals
required for the transaction may not be obtained on the terms expected or on the anticipated schedule; the parties’ ability to
meet expectations regarding the timing, completion and accounting and tax treatments of the merger; the impact of
indebtedness incurred by Bayer in connection with the transaction and the potential impact on the rating of indebtedness of
Bayer; the effects of the business combination of Bayer and Monsanto, including the combined company’s future financial
condition, operating results, strategy and plans; other factors detailed in Monsanto’s Annual Report on Form 10-K filed with
the U.S. Securities and Exchange Commission (the “SEC”) for the fiscal year ended August 31, 2015 and Monsanto’s other
filings with the SEC, which are available at http://www.sec.gov and on Monsanto’s website at www.monsanto.com; and other
factors discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. Bayer assumes no
obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not
to place undue reliance on these forward-looking statements that speak only as of the date hereof.
Cautionary Statements Regarding Forward-
Looking Information
Meet Management in Cologne • September 20, 2016
This communication relates to the proposed merger transaction involving Monsanto and Bayer. In connection with the
proposed merger, Monsanto and Bayer intend to file relevant materials with the SEC, including Monsanto’s proxy statement
on Schedule 14A (the “Proxy Statement”). This communication does not constitute an offer to sell or the solicitation of an
offer to buy any securities or a solicitation of any vote or approval, and is not a substitute for the Proxy Statement or any
other document that Monsanto may file with the SEC or send to its stockholders in connection with the proposed merger.
STOCKHOLDERS OF MONSANTO ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC,
INCLUDING THE PROXY STATEMENT, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to
obtain the documents (when available) free of charge at the SEC’s web site, http://www.sec.gov, and Monsanto’s website,
www.monsanto.com, and Monsanto stockholders will receive information at an appropriate time on how to obtain transaction-
related documents for free from Monsanto. In addition, the documents (when available) may be obtained free of charge by
directing a request to Corporate Secretary, Monsanto Company, 800 North Lindbergh Boulevard, St. Louis, Missouri 63167,
or by calling (314) 694-8148.
Monsanto, Bayer and their respective directors and executive officers may be deemed to be participants in the solicitation of
proxies from the holders of Monsanto common stock in respect of the proposed transaction. Information about the directors
and executive officers of Monsanto is set forth in the proxy statement for Monsanto’s 2016 annual meeting of stockholders,
which was filed with the SEC on December 10, 2015, and in Monsanto’s Annual Report on Form 10-K for the fiscal year
ended August 31, 2015, which was filed with the SEC on October 29, 2015. Other information regarding the participants in
the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be
contained in the Proxy Statement and other relevant materials to be filed with the SEC in respect of the proposed transaction
when they become available.
Additional Information and Where to Find It
Meet Management in Cologne • September 20, 2016
Meet Management in Cologne • September 20, 2016Page 4
Building Leading Life Science Businesses
to Create Value
Division Leadership Position
Leading position in cardiology, hematology,
radiology, women’s health
Global #1 OTC business with strong portfolio
of leading brands
After the acquisition of Monsanto, a global
leader in seeds, traits, crop protection and
digital farming; #5 globally in Animal Health
Pharmaceuticals
Consumer Health
Crop Science /
Animal Health
Acquisition of Monsanto pending
Page 5
Monsanto Acquisition - Transformative Step to
Strengthen Life Science Portfolio
2015 Pro Forma Life Science Sales
Health care
businesses
49%
Crop
Science
Total
€47.1bn
Monsanto
49%
combined
pro forma
Excluding Covestro
Monsanto sales calculated at avg. 2015 Fx rate (USD/EUR=1.11)
Industry Leadership
• Creating a global leader in agriculture with
an integrated agricultural offering
• Broad product portfolio and R&D pipeline to
deliver enhanced solutions for farmers
Significant Value Creation
• Substantial synergy potential
• Accretion to core EPS in the first full year
• Potential for premium valuation of combined
agriculture business
Consistent with Bayer’s Strategy
• Agriculture market driven by innovation
• Attractive long-term growth market
• Building of leadership position
Meet Management in Cologne • September 20, 2016
Acquisition of Monsanto pending
Key Metrics of the Monsanto Transaction
Page 6 Meet Management in Cologne • September 20, 2016
Acquisition of Monsanto pending
Offer
Summary
• All-cash consideration of $128 per Monsanto share
• Enterprise value (EV) of $66bn including net debt
• Transaction unanimously approved by Monsanto’s Board of
Directors, Bayer’s Board of Management and Bayer’s
Supervisory Board
Key
Metrics
• Premium of 44% to Monsanto’s undisturbed share price of
$89.03(1)
• Premium of 43% to Monsanto’s three-month volume weighted
average share price(1)
• LTM(2) EBITDA multiple of 18.6x as of May 31, 2016;
consensus(3) FY 2017 EBITDA multiple of 16.5x
(1) As of May 9, 2016, the day before Bayer’s first written proposal to Monsanto; (2) Last Twelve Months
(3) as per Bloomberg, Sep 13, 2016; Fx rate: USD/EUR=1.11
Key Metrics of the Monsanto Transaction (cont´d)
Page 7 Meet Management in Cologne • September 20, 2016
Acquisition of Monsanto pending
Value
Creation
• Significant value creation through expected synergies confirmed
in due diligence:
• ~$1.5bn annual net synergies after year three
(~80% cost, ~20% sales)
• Additional synergies from integrated solutions increasing
over the years thereafter
• Transaction expected to be accretive to core EPS in the first full
year after closing; double-digit percentage core EPS accretion
expected in the third full year after closing
• Expect to earn cost of capital after year 4 post closing
Financing
• Permanent financing expected to consist of a combination of debt
and equity
• Expected equity component of ~$19bn, expected to be raised
through issuance of mandatory convertible bonds and through a
rights issue with subscription rights
Path to Completion of the Monsanto Transaction
Page 8
Acquisition of Monsanto pending
Meet Management in Cologne • September 20, 2016
• September 14, 2016: Signing of merger agreement between Bayer and
Monsanto
• September, 2016: Commence discussions with regulatory agencies
• Late 2016/ early 2017: Monsanto to convene shareholder meeting to vote on
merger agreement
• Closing expected by the end of 2017
Meet Management in Cologne • September 20, 2016Page 9
Proven Track Record of Successful
Portfolio Management
Lanxess
Schering
Diagnostics
H.C. Starck
Wolff Walsrode
Dihon
Algeta
Merck OTC
Covestro
(partial IPO) Diabetes
Care
Roche
OTC
Conceptus
Steigerwald
Interventional
Number of closed transactions
Total transaction value
Signing of
merger
agreement
with Monsanto
Transforming into a Life Science company –
total transaction value of ~€52bn in ~130 closed deals since 2005
AgraQuest
Stoneville Cotton Seed
Athenix
Rebuilding Pharma
Strengthening HealthCare
and CropScience
Transforming into a
Life Science company
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Acquisition of Monsanto pending
Meet Management in Cologne • September 20, 2016Page 10
Clear Portfolio Management Criteria Drive
Value Generation
• Focus on markets with long-term GDP+
growth potential
• Ability to generate attractive returns
• Success driven by innovation-based
business models
• Potential to achieve leadership positions
• Bayer as the best owner
General Portfolio Criteria
• Decisions based on regular portfolio
review and market opportunity
• Strong DCF-based value creation
imperative
• Key performance indicators including
sales growth relative to market, core EPS
accretion and value generation
• No capital allocation to one business at
the cost of underinvestment in another
business
• Proven integration/ separation
capabilities
Portfolio Management Approach
1 2015 figures restated, Crop Science as reported;
2 2015 pro forma combined EBITDA margin; Monsanto calendarized to December 2015 year-end;
3 From December 31, 2004 through September 13, 2016
Proven Integration
Track Record
Building Leading Life Science Franchise
Meet Management in Cologne • September 20, 2016Page 11
Delivering Shareholder Value Through
Strong Execution
3.2
15.3
2004 2015
1.3
6.1
2004 2015
5.9 10.4
12.7
2004 2015
Rebuilt Pharma
Global
Leadership in
Consumer Health
23.1
Monsanto
Building a
New Leader in
Crop Science
• Experienced acquirer having
successfully integrated various
multi-billion € transactions
• Aventis CropScience
• Schering
• Roche OTC
• Merck & Co. Consumer Care
• Monsanto integration no more
complex than previous large
integrations
+
20
Sales and EBITDA Margin1
2130 24 21 ~272
Sales, €bn EBITDA Margin, %
Increased market cap ~4x since 20043
Meet Management in Cologne • September 20, 2016Page 12
Consistent Track Record of
Strong Operating Performance
Continued businesses for 2014/2015; 2015 figures restated
Adj. EBITDA: EBITDA before special items
35.1 36.5
39.7 40.2 41.3
46.1
7.1 7.6 8.3 8.4 8.7
10.3
2010 2011 2012 2013 2014 2015
4.83 5.30 5.61 5.89 6.824.19
20.2
20.8 20.8 20.9
21.0
22.3
CAGR
2010-2015
Sales +6%
Adj. EBITDA +8%
Core EPS +10%
Sales (€bn)
Adj. EBITDA (€bn)
Adj. EBITDA margin (%)
Core EPS (€)
Meet Management in Cologne • September 20, 2016Page 13
H1 2016 – Successful Operating
Performance and Strategic Progress
2015 figures restated
Sales
€m, % FX & portf. adj.
EBIT
€m
+3%
23,68723,769
H1’16H1’15
+19%
4,458
3,748
H1’16H1’15
EBITDA
before special items, €m
Core EPS
cont. operations, €
+11%
6,441
5,810
H1’16H1’15
+9%
4.42
4.05
H1’16H1’15
 New approvals for Kovaltry and Xofigo
 Patent term for Rivaroxaban extended
in USA
 Positive phase III data for Regorafenib
in unresectable liver cancer
 Stake in Covestro reduced to 64%
 All-cash offer to acquire Monsanto
published
 Agreement signed to sell the Consumer
business of Environmental Science
 Closing of Diabetes Care divestment
 Outlook for 2016 raised
Highlights H1 2016
Meet Management in Cologne • September 20, 2016Page 14
FY 2016 – Group Outlook Raised
2015 figures restated
Assuming end Q2 2016 Fx rates (USD 1.11)
Outlook depends on specific planning assumptions as detailed in the Annual Report
Sales ∆ % yoy Fx and portfolio adj., EBITDA before special items;
Continuing operations
2015
2016
update July
Sales
Group €46.1bn Low-single-digit % increase to €46–47bn
Life Sciences €34.1bn Mid-single-digit % increase to ~€35bn
Adj.
EBITDA
Group €10.3bn High-single-digit % increase
Life Sciences €8.6bn Mid- to high-single-digit % increase
Core EPS €6.82 Mid- to high-single-digit % increase
Meet Management in Cologne • September 20, 2016Page 15
Mid-Term Aspirations Emphasize
Attractive Growth and Margin Potential
Sales ∆ Fx & portf. adjusted, EBITDA before special items, continuing operations
Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
Sales Growth
CAGR 2015-2018
Adjusted EBITDA
Margin 2018
Pharma ~6%
32-34%
Despite dilution through Radiology
and significant R&D investment
Consumer
Health
4-5% ~25%
Animal Health 4-5% 23-24%
Crop Science
(incl. Monsanto)*
Above market growth
>30% after year 3
post closing
Acquisition of Monsanto pending
* Not including any potential divestments
Aspiration
2018
Meet Management in Cologne • September 20, 2016Page 16
Increased Underlying Pharma Margin
Expectations for 2018
Pharma EBITDA margin before special items
1) RAD: Radiology business became part of Pharma effective Jan. 1, 2016
2) Current planning for 2018 compared to planning in 2015
As of March
2015
As of September
2016
32–34%
Depending on level
of R&D investment
32–34%
Depending on level
of R&D investment
Aspiration
2017
Margin
Dilution by
RAD1
Higher
R&D
Investment2
Per-
formance
-0.8% pts
-0.6% pts
Fx
+0.3% pts
+1.1% pts
Meet Management in Cologne • September 20, 2016Page 17
Focused Leadership Strategy at Pharma to
Deliver Growth and to Create Value
• Deliver on mid-term
growth and margin
aspirations
• Balance margin
expansion and need to
invest in securing long-
term growth
• Build pipeline organically
and pursue in-licensing
and bolt-on M&A options
• Focus research on
Cardiovascular and
Oncology
• Foster late-stage
development to fully
develop high value
projects
• Support leading
positions in Hemophilia,
Women’s Health and
Ophthalmology
• Focus on key therapeutic
areas and build / main-
tain leading positions
• Cardiovascular
• Hemophilia
• Women’s Health
• Oncology
• Continue to maximize
growth potential of
Xarelto, Eylea, Xofigo,
Stivarga, Adempas
Deliver Growth Drive Innovation Create Value
Xarelto
Stivarga
Eylea
Adempas
Xofigo
Rec. Launched Products
Meet Management in Cologne • September 20, 2016Page 18
Combined Peak Sales Potential of Recently
Launched Products Increased to > €10bn
* PSP: peak sales potential
> €5bn
~ €3.5bn
New PSP*Old PSP
> €2.5bn
≥ €1.5bn
New PSP*Old PSP
> €1bn≥ €1bn
New PSP*Old PSP
≥ €1bn≥ €1bn
New PSP*Old PSP
> €0.5bn≥ €0.5bn
New PSP*Old PSP
> €10bn
≥ €7.5bn
New PSP*Old PSP
Meet Management in Cologne • September 20, 2016Page 19
Consumer Health to Maintain Global OTC
Leadership and to Improve Profitability
• Accelerate consumer-
centric innovation
• Create more effective
innovation processes
• Exploit growth potential
of Rx/OTC switches
• Build new digital
capabilities
• Deliver growth in key
markets including USA,
China, Brazil, Russia
• Refocus investments to
mature markets which
are regaining momentum
• Continue prudent
investments in emerging
markets
• Leverage scale to grow
more profitably
• Focus on category-
leading, global brands
• Execute brand strategies
in a differentiated,
country-specific
approach, tailored to
local market
requirements
Build Global Brands Drive Key Market Growth Accelerate Innovation
Meet Management in Cologne • September 20, 2016Page 20
Broad Portfolio of Consumer Health Brands
with Sales of > €100 million p.a. Each
Sales FY 2015
* including Rx Aspirin Cardio
** Alka Seltzer family
€997 million* €627 million €413 million €355 million
€128 million €111 million €110 million
€267 million €253 million €251 million** €218 million
€211 million €162 million €159 million €158 million
Meet Management in Cologne • September 20, 2016Page 21
Key Takeaways Two Years After the Acquisition
of Merck & Co’s Consumer Care Business
• Key brands (e.g. Coppertone & Dr. Scholl´s) were underinvested
• Weak product pipeline (low visibility during bidding process)
• Product discontinuation (Oxytrol)
• Underestimated country risk from Emerging Markets volatility
• Stronger business disruption than anticipated during integration of Merck
Consumer Care & Dihon in China
Focus on delivering the full potential of Merck & Co. Consumer Care by
• Increased investment in key brands
• Rebuilding Coppertone and Dr. Scholl´s
• Driving growth in the USA supported by significant new product introductions
Meet Management in Cologne • September 20, 2016Page 22
Combined Crop Science Company Well
Positioned to Deliver Superior Performance
• Realize full synergy
potential of the combined
businesses
• Deliver above market
growth and superior
margins
• Advance strong pipeline
across crops, indications
and technologies
• Deploy joint innovation
capabilities to deliver
enhanced solutions for
the next generation of
farming
• Deliver integrated
systems based on
technologies optimally
designed to work
together
• Create integrated
agriculture offerings
• Fully leverage
combinations and
optimized usage of
products based on
agronomic advice and
digital farming
• Enable integrated
solutions for broad-acre
crops corn and soy
Integrated Solutions Lead Innovation Deliver Value Proposition
Acquisition of Monsanto pending
Meet Management in Cologne • September 20, 2016Page 23
Significant Strategic Benefits Due to
Strong Position Along Key Criteria
A leading player with significant revenue base and high R&D spendScale
Broad product portfolio across indications and cropsBreadth
Best-in-class combination of science, innovation history and
R&D effort globally
R&D
Combination of the high-quality seeds & traits and
crop protection pipelines across key crops
Pipeline
Ability to provide farmers with integrated solutions immediately and
into the future
Integrated
Solutions
Opportunity to create a global leader by combining
strengths of both organizations in digital farming
Digital
Farming
Acquisition of Monsanto pending
Meet Management in Cologne • September 20, 2016Page 24
Confidence in Our R&D Investments
R&D 2016e: ~€4.5bn
• 55 projects in clinical development at
Pharma
• 30 successful phase III clinical trials
at Pharma since 2010
• Strengthened brands through multiple
line or product introductions at
Consumer Health
• Launched 12 active ingredients
between 2006 and 2016 at Crop
Science
• New product introductions at Animal
Health (Seresto, Zelnate / Victrio)
Achievements
Covestro
Pharma
Animal
Health
58%
25%
6%
Crop Science
6% Recon. 2%
Consumer Health
3%
Meet Management in Cologne • September 20, 2016Page 25
Increased R&D Spending at Pharma -
Significant Investment in Life Cycle Management
2015 R&D Investment at Pharma
Research
~20%
~45%
Life Cycle
Management
1.8
1.7 1.7
1.8
2.0
2.4
2010 2011 2012 2013 2014 2015
15.8
14.6
13.5
13.9
14.7
15.7
R&D as % of sales
Development
€2,402m
~35%
€ billion;
Pharma including Radiology
Meet Management in Cologne • September 20, 2016Page 26
Key Pharma Pipeline Assets With Combined
Peak Sales Potential of  €6 billion
Pipeline Project Indication
Peak Sales
Potential
Vericiguat1
Worsening chronic heart failure ~ €0.5bn
Finerenone Diabetic kidney disease ≥ €1.0bn
Vilaprisan Uterine fibroids ≥ €1.0bn
BAY-1841788
(ODM-201)
Non-metastatic castration-resistant prostate cancer
Metastatic hormone-sensitive prostate cancer
≥ €1.0bn
Anetumab Various cancers2
≥ €2.0bn
Copanlisib Lymphoma ≥ €0.5bn
1) In cooperation with Merck & Co.
2) Ovarian, Mesothelioma, etc.
Stivarga
HCC 2L
Visanne
Endo
Amikacin
inhale
Damoctocog
alpha
Tedizolide
ODM-201
nmCRPC
Anetumab
Cancer
Xofigo
combo
Xarelto LCM
• MACE
• ESUS
• CHF
• Med. ill
Finerenone
DKD
Xarelto LCM
PAD
Vilaprisan
UF
Vericiguat
WCHF
Xofigo
Breast
Riociguat
Syst. Sclerosis
Anetumab
Cancer
ODM-201
mHSPC
Meet Management in Cologne • September 20, 2016Page 27
New Product and Life Cycle Management
Launches Planned at Pharma
First expected launches in first countries; Eylea Life Cycle Management not included
Selection of projects, regional and small projects not shown;
Launches subject to successful clinical development and regulatory approval
2017 2018 2019 2020 2021 2022 2023
Xarelto LCM
ACS dual
Copanlisib
Lymphoma
24-hour nasal glucocorticoid formulated to relieve nasal
allergy symptoms
Analgesic for relief of occasional sleeplessness when
associated with minor aches and pains
New formulation of Aspirin that works twice as fast
as previous Aspirin tablets
Specialist suncare leveraging Bepanthen’s strong derma-
tology equity and Bayer’s health credentials
Food supplement rich in vitamins and minerals formulated
as orodispersable tablet
Meet Management in Cologne • September 20, 2016Page 28
Robust Consumer-Centric Innovation at
Consumer Health
Examples only
ClariSpray
Aleve PM
Micro Active
Aspirin
Bepanthen
Sun
Berocca
On-the-Go
Meet Management in Cologne • September 20, 2016Page 29
Creation of a Leading Innovator
2.5
1.6
1.3
0.7
Bayer CS +
Monsanto
Dow Ag +
DuPont Ag
Syngenta +
ChemChina
Ag
BASF Ag
11.410.6 10.6 8.5% of
Sales
• > 40 major R&D sites worldwide
• > 200 breeding stations in all
relevant geographies
• ~10,000 employees in R&D
• Strong R&D technology platform
• Cross-technology capabilities
• > 70 pipeline advancements over
last two years
2015 Pro Forma R&D Investment (€bn)1
Seeds & TraitsCrop Protection Total
3
Strong pipeline across crops, indications and technologies
Combined Strength in Innovation2
1 Based on company information and internal calculations excl. synergies (at avg. 2015 Fx rate USD/EUR=1.11)
2 Pro forma; 3 BASF: includes ~€150 million for Plant Science
Meet Management in Cologne • September 20, 2016Page 30
Bayer – A World-Class Life Science Company
LCM: Life Cycle Management; LoE: Loss of exclusivity; PSP: Peak sales potential
Acquisition of Monsanto pending
Value-
Creating
Portfolio
Management
Continuous
Prosperous
Performance
Excellence in
Innovation
to Foster
Future Growth
• Creating a global leader in agriculture through acquisition of Monsanto
• Proven integration/separation capabilities
• Track record of delivering shareholder value through successful
portfolio management
• Upcoming new product launches and LCM at Pharma expected to
mitigate LoE post 2023
• Combined PSP of key late-stage Pharma pipeline assets €6bn
• Consumer Health delivering steady stream of consumer-centric innovations
• Strong R&D capabilities at combined Crop Science business
• Mid-term aspirations emphasize growth and margin potential
• Pharma launch products expected to drive growth; PSP increased to >€10bn
• Consumer health challenges addressed
• Crop Science expected to benefit from cyclical market upswing and
long-term GDP+ growth potential
Meet Management in Cologne – September 20, 2016
Dieter Weinand, Member of the Board of Management, Head of Pharmaceuticals
Investor Presentation – Pharma
Meet Management in Cologne • September 20, 2016Page 2
Fast-Growing Pharma Business
10.0 9.9
10.8 11.2
12.1
15.3
2010 2011 2012 2013 2014 2015 1H'16
€ billion; ∆% yoy Fx & portfolio adj.
Sales
Leading novel oral
anti-coagulant
Successful launch
of 5 products
Success in treatment of
retinal diseases
First-in-class
-pharmaceutical
First marketed sGC
modulating agent
Multi-kinase inhibitor
for cancer treatment
8.0
2015 figures restated
+10%
+1%
+4%
+9%
+11%
+9%
Meet Management in Cologne • September 20, 2016Page 3
FY 2016 Guidance Increased
2015
2016
(update July)
Sales €15.3bn High-single-digit % increase to >€16bn
Sales of Recently Launched
Products
€4.2bn Toward €5.5bn
EBITDA
before special items
€4.6bn Low-teens % increase
Adj. EBITDA margin 30.1% Improve
Assuming end Q2 2016 Fx rates (USD 1.11); Outlook depends on specific planning assumptions as detailed in the Annual Report;
2015 figures restated
Sales ∆ Fx & portf. adjusted, adj. EBITDA margin = EBITDA before special items to sales
Meet Management in Cologne • September 20, 2016Page 4
Mid-Term Aspirations 2018
2015 Aspiration 2018
Sales
+9.1% to
€15.3bn
~6% CAGR (2015-2018)
Adj. EBITDA margin 30.1%
32 - 34%
despite dilution through RAD and
significant investment in R&D
2015 figures restated; RAD: radiology business – became part of Pharma effective January 1, 2016
Sales ∆ Fx & portf. adjusted, EBITDA before special items
Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
Meet Management in Cologne • September 20, 2016Page 5
Combined Peak Sales Potential of Recently
Launched Products Raised to >€10bn
Combined peak sales potential for Xarelto, Stivarga, Eylea, Xofigo and Adempas assuming approvals and launches as planned;
LCM: life cycle management; CRC: colorectal cancer; HCC: hepatocellular cancer; PH: pulmonary hypertension
Old
~€3.5bn
≥€1.5bn
≥€1bn
≥€1bn
≥€0.5bn
Current
>€5bn
>€2.5bn
>€1bn
≥€1bn
>€0.5bn
• Continued successful
performance and LCM
• Continued successful performance
• Broadened LCM activities
• Positive phase III in 2nd line HCC
• Phase III in adjuvant CRC initiated
• Multiple LCM activities including
non-PH indications
• Continued successful
performance
Meet Management in Cologne • September 20, 2016Page 6
Fully Realize Pipeline Potential
* Combined peak sales potential for assets as above assuming approvals and launches as planned; nmCRPC: non-metastatic castration resistant
prostate cancer; mHSPC: metastatic hormone-sensitive PC; WCHF: worsening chronic heart failure
Anetumab-
Ravtansine ODM-201 Finerenone Vilaprisan Vericiguat
2019 2019 2020 2021 2021
≥€2bn ≥€1bn ≥€1bn ≥€1bn ~€0.5bn
Various
cancer types
nmCRPC
mHSPC
Diabetic
kidney disease
Uterine
fibroids
WCHF
Copanlisib
2018
≥€0.5bn
Lymphoma
Combined* Peak Sales Potential ≥€6bn
first expected launches in first countries
Meet Management in Cologne • September 20, 2016Page 7
Focused Leadership Strategy for Pharma
Build on leading positions in
• Cardiology / Thrombosis
• Woman’s HealthCare
• Hemophilia
Establish focused segment leadership positions in Oncology
• Realize blockbuster potential for marketed drugs Xofigo and Stivarga
• Focus and reinforce Oncology R&D
Fully realize pipeline potential
Meet Management in Cologne • September 20, 2016Page 8
Leading Cardiovascular Portfolio
LCM: life cycle management; HFrEF: heart failure with reduced ejection fraction; HFpEF: HF with preserved EF;
PoC: proof of concept; DKD: diabetic kidney disease; CV: cardiovascular
Thrombosis
Heart
Failure
Kidney
Mature
Brands
• Fully support Finerenone in DKD to build a leadership position in nephrology
• Pursue out-licensing options for Molidustat
• Advance early pipeline projects to establish franchise
• Continue Ph3 preparation of Vericiguat (HFrEF) in collaboration with Merck & Co. Inc.
• Pursue development of Neladenoson (Partial A1agonist) in HFrEF and HFpEF in parallel
• Continue to advance chymase inhibitor and dual vasopressin receptor antagonist to PoC
• Xarelto performance excellent – peak sales estimate raised to >€5bn
• Continue to invest in Xarelto LCM and launch preparations of LCM indications
• Pursue FXI/FXIa inhibition approach
• Adalat – a cornerstone in CV disease treatment
• Glucobay – continued growth expected in Emerging Markets, especially China
• Aspirin Cardio – continued growth expected
Meet Management in Cologne • September 20, 2016Page 9
Xarelto – Peak Sales Potential Estimates
Raised - Again
€ billion
Peak Sales Estimates
2007 2014 2016
• Continued excellent performance –
Xarelto now a TOP 15 global Pharma
brand1
• >21 million patients treated since
launch2
• Further growth potential driven by:
• Under-served patient populations in
launched indications
• Demographics
• Shift from warfarin
• New indications targeting patients
currently not treated with
anticoagulants
1: according to IMS; 2: calculation based on IMS Health MIDAS database
>2.0
~3.5
>5.0
Meet Management in Cologne • September 20, 2016Page 10
Xarelto Life Cycle Management Program
Addressing The Full Range of Unmet Need
Stroke
Prevention
Arterial
Thromboembolism
Venous
Thromboembolism
CAD: coronary artery disease; PAD: peripheral artery disease; VTE: venous thromboembolism
• Patients with Atrial Fibrillation
• Patients without Atrial Fibrillation
• Patients with acute CAD/PAD
• Patients with chronic CAD/PAD
• Patients with venous thromboembolism
• Patients in need for VTE prevention
Meet Management in Cologne • September 20, 2016Page 11
Finerenone – Opportunity to Lead in
Diabetic Kidney Disease
DKD: diabetic kidney disease; CKD chronic kidney disease; MRA: mineralocorticoid receptor antagonist
• Finerenone is a novel non-steroidal
MRA with a differentiated profile
• Steroidal MR antagonists are not
approved for kidney diseases
• A Finerenone phase IIb (ARTS-DN)
study in Diabetic Nephropathy was
successfully completed
Finerenone
 Significant need for innovative therapies
 Phase III program in DKD progressing as planned
• Market for chronic kidney disease
estimated at ~$14bn in 2024
• Resulting complications from Diabetes
accounting for 35% of CKD
• ~40% of new cases of end-stage renal
disease (ESRD) are due to Diabetes
Mellitus (DM)
• Patients with Type II DM and CKD are at
high risk of cardiovascular (CV) death
Diabetic Kidney Disease
Meet Management in Cologne • September 20, 2016Page 12
Vericiguat – Potential First-in-Class Treatment
for Chronic Heart Failure
• A lack of sGC stimulation leads to the reduced activity of the “nitric oxide-
sGC-cGMP” pathway, causing coronary dysfunction and progressive
myocardial damage
• By directly stimulating the critical enzyme sGC, Vericiguat restores this
pathway and in turn may improve heart and vascular function
• Phase III (VICTORIA) trial assesses a potential reduction in mortality and
morbidity on top of standard of care in HFrEF patients
• VICTORIA trial initiated1
1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic heart failure;
HFrEF: heart failure with reduced ejection fraction
Novel approach targeting the critical cGMP cardiovascular
pathway that is impaired in CHF patients
Meet Management in Cologne • September 20, 2016Page 13
Establish Focused Leadership Positions
in Oncology
nmCRPC: non-metastatic castration resistant prostate cancer; LCM: life cycle management; ADC: antibody-drug conjugate; iNHL: indolent Non-
Hodgkin’s lymphoma
Xofigo
• Target “agent of choice” status - clear survival benefit for patients with bone
metastases in prostate cancer demonstrated
• Expand in additional cancer types beyond prostate cancer
Stivarga
Nexavar
Focus
Oncology
R&D
Execute
launch
pipeline
• Build position in hepatocellular carcinoma (HCC)
• Strengthen position in colorectal cancer through LCM in adjuvant setting
• Reinforce leadership in liver cancer through capitalizing on optimal treatment
continuum / sequence for Nexavar & Stivarga in HCC
• Differentiation for leadership in selected areas (Thorium platform; ADC’s)
• Focus on differentiated programs
• Stivarga HCC 2L  launch 2017e
• Copanlisib iNHL  launch 2018e
• Anetumab R. mesothelioma  launch 2019e
• Xofigo additional indications/uses
 first launch 2019e
• ODM-201 in nmCRPC
 launch 2019e
Meet Management in Cologne • September 20, 2016Page 14
Expanding Xofigo’s Position in Castration-
Resistant Prostate Cancer Treatment
For details on approved indications see respective product labels;
Zytiga® is a trademark of Johnson & Johnson
Metastatic castration-resistant prostate cancer
Asymptomatic bone metastases
Potential new disease area
for combination therapy
Symptomatic bone metastases
Xofigo
(radium Ra 223 dichloride injection)
Novel antihormonal agents
(eg. Zytiga® [abiraterone])
Chemotherapy
• Combination therapy with abiraterone, an inhibitor of testosterone synthesis
• Expansion to earlier disease stages enhances accessible patient population
• A delay of skeletal-related events is of major clinical importance
• ODM-201 is a potent and full AR antagonist
• Promising efficacy profile demonstrated in previous studies
• Inhibits growth of prostate cancers in preclinical studies
• Significantly decreases PSA levels in patients with progressive CRPC
• Sustained PSA reduction was observed at higher dose levels
• ODM-201 antagonizes mutant ARs linked to resistance to other AR antagonists
(ie, bicalutamide, enzalutamide)
• Phase III program ongoing addressing
i. hormone sensitive metastatic prostate cancer
ii. non-metastatic CRPC
Meet Management in Cologne • September 20, 2016Page 15
ODM-201 – A Novel, New-Generation
Nonsteroidal AR Antagonist
AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen
Meet Management in Cologne • September 20, 2016Page 16
R&D Differentiates Through Targeted Alpha-
Pharmaceuticals and Novel Toxophor ADCs
• Thorium-platform unique to Bayer
• Thorium-platform offers to deliver
alpha emitters to every tumor
• Thorium-platform offers synergies
with Xofigo with respect to
manufacturing and supply chain
• Advanced and broad ADC program
established
• Synergies between Thorium – and
ADC platforms with respect to
antigens, antibodies, linker
technologies, etc.
223Ra
Decay
Targeted Thorium Conjugates (TTCs)
Antibody Drug Conjugates (ADCs)
Meet Management in Cologne • September 20, 2016Page 17
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
• Fast proof of concept targeted –
Phase I for -CD22 Th-227
conjugate progressing
• Next steps initiated to explore
Thorium platform in solid tumors
+ Th-227
Percentsurvival
CB17 SCID
Statistical
Analysis
(Mantel-Cox
test)
< 0.0001
(****)
Animals treated 5 days after inoculation of HL60 (AML)
For all surviving animals no tumors
were found on dissection
Preclinical disseminated AML tumor model
AML: acute myeloid leukemia
Meet Management in Cologne • September 20, 2016Page 18
Anetumab Ravtansine Program Advancing
* Blumenschein et al. ASCO 2016; ADC: antibody drug conjugate
Mode of action:
• ADC targeting tumor-associated antigen
mesothelin, and delivering toxophore DM4,
which acts on proliferating cells (tubulin
inhibitor)
Potential spectrum of indications
determined by mesothelin expression
pattern:
• mesotheliomas (100%)
• pancreatic cancer (~80-100%) and
• ovarian adenocarcinomas (~80%)
Clinical program:
• Phase I* with promising results including
duration of treatment of > 1,000 days
• Registrational phase II in metastatic pleural
mesothelioma ongoing
Meet Management in Cologne • September 20, 2016Page 19
Summary
• Projecting future growth for Pharma
• Peak sales estimates for recently launched products increased to
> €10bn
• Pipeline holds promise with a peak sales potential* of selected assets of
≥ €6bn
• Build on existing leading positions in key therapeutic areas
• Expand successful cardiovascular business
• Focus Oncology portfolio and build leading segment positions
* Combined peak sales potential for Copanlisib, Anetumab Ravtansine, Finerenone, Vericiguat, Vilaprisan and ODM-201 assuming approvals and
launches as planned
Meet Management in Cologne • September 20, 2016Page 20
Proven Track Record of Successful
Portfolio ManagementSummary
Page 20 Meet Management Cologne • September 20, 2016
APPENDIX
Meet Management in Cologne • September 20, 2016Page 21
Proven Track Record of Successful
Portfolio ManagementSummary
Page 21 Meet Management Cologne • September 20, 2016
Leading
Cardiovascular
Portfolio
• Xarelto continues its outstanding performance in 2016 – became one of
the TOP 15 Global Pharma Brands according to IMS
• Confident in growth potential – Xarelto’s peak sales potential estimate
raised to >€5bn
• Comprehensive life cycle management program to support future growth
• Beyond, Xarelto, Factor XI pathway is a research focus to potentially lead
the next wave of innovation in thrombosis
Meet Management in Cologne • September 20, 2016Page 22
Bayer – A Leading Player in Thrombosis
Meet Management in Cologne • September 20, 2016Page 23
Xarelto Life Cycle Management Program
Addressing The Full Range of Unmet Need
Stroke
Prevention
Arterial
Thromboembolism
Venous
Thromboembolism
CAD: coronary artery disease; PAD: peripheral artery disease; VTE: venous thromboembolism
• Patients with Atrial Fibrillation
• Patients without Atrial Fibrillation
• Patients with acute CAD/PAD
• Patients with chronic CAD/PAD
• Patients with venous thromboembolism
• Patients in need for VTE prevention
Meet Management in Cologne • September 20, 2016Page 24
Xarelto Life Cycle Management Studies:
Addressing Stroke Prevention
Study Indication Objective Completion*
Secondary stroke
prevention in
patients with a
recent ESUS
Evaluate whether Rivaroxaban is superior to aspirin
in reducing the risk of recurrent stroke and systemic
embolism in patients with a recent Embolic Stroke of
Undetermined Source (ESUS) (N~7,000)
Q4’17e
SPAF/
ACSsp
Safety of two Rivaroxaban regimens vs. VKA after
PCI in non-valvular AF patients (N~2,100)
Q2’16e
Transcatheter
aortic valve
replacement
(TAVR)
To assess a Rivaroxaban-based anticoagulation
regimen following successful TAVR balancing
ischemic and bleeding outcome measures (N~1,500)
tbd
SPAF
Efficacy and safety of Rivaroxaban for prevention
of CV events in non-valvular AF patients undergoing
cardioversion vs. VKA (N=1,504)
Completed
and reported
SPAF
Safety of uninterrupted Rivaroxaban vs VKA in non-
valvular AF patients undergoing catheter ablation
(N~250)
Completed
and reported
SPAF
Efficacy of Rivaroxaban for LA thrombus resolution in
non-valvular AF/flutter patients (N~60)
Completed
and reported
SPAF
Safety of Rivaroxaban for stroke prevention in
non-valvular AF. Region: Europe (N=6,784)
Completed
and reported
* current estimates on primary completion
Meet Management in Cologne • September 20, 2016Page 25
Xarelto Life Cycle Management Studies:
Addressing Arterial Thromboembolism
Study Indication Objective Completion*
Coronary artery
disease (CAD) /
peripheral artery
disease (PAD)
Efficacy and safety of Rivaroxaban vs. low-dose
Rivaroxaban plus ASA or ASA alone in reducing the
risk of major cardiac events in patients with CAD or
PAD (N~27,000)
1H’18e
Heart failure (HF) /
coronary artery
disease (CAD)
Efficacy of Rivaroxaban vs. placebo in patients with
significant CAD and HF receiving antiplatelet therapy
(N=5,000)
1H’18e
Peripheral artery
disease (PAD)
To assess the potential benefits of Rivaroxaban in
reducing major thrombotic vascular events in
patients with PAD undergoing peripheral artery
interventions (N=6,500)
1H’19e
ACSsp
Safety of Rivaroxaban vs. ASA in combination with
single antiplatelet treatment (Clopidogrel or
Ticagrelor) for long-term secondary prevention in
patients with recent ACS in a broader range of
patients (N=2,000 – 3,000).
If successful, this phase II study will be followed by a
confirmatory, fully powered global phase III study
End 2016e /
early 2017e
ACSsp
Rivaroxaban plus dual antiplatelet therapy vs. UFH
during elective PCI (N=107)
Completed
and reported
* current estimates on primary completion; UFH: unfractionated heparin; PCI: percutaneous coronary intervention
Meet Management in Cologne • September 20, 2016Page 26
Xarelto Life Cycle Management Studies:
Addressing Venous Thromboembolism
* current estimates on primary completion
Study Indication Objective Completion*
Long-term preven-
tion of recurrent
symptomatic VTE in
patients with symp-
tomatic DVT and /
or PE
Efficacy and safety of reduced-dosed Rivaroxaban,
standard-dosed Rivaroxaban vs. ASA for preventing VTE
in patients with symptomatic DVT and/or PE (N=3,300)
End 2016e
Rivaroxaban in
cancer associated
thrombosis
Program with oncology-based, complementary studies to
address oncologists questions on treatment and
prevention of VTE, while building Xarelto treatment
pathways into the cancer care environment. A compilation
of different studies
ongoing
Medically ill patients
at risk of VTE after
hospital discharge
Efficacy and safety of Rivaroxaban vs. placebo in
reducing post-discharge VTE risk in medically ill patients
(N=8,000)
1H’18e
VTEx in children
Efficacy and safety of Rivaroxaban vs. SOC for treatment
and secondary prevention of VTE in the paediatric
population. A series of phase I, II, III studies (N=160)
1H’19e
VTEp OS
Safety and efficacy of Rivaroxaban vs SOC in VTE
prophylaxis after major orthopaedic surgery (N=17,701)
Completed
and reported
VTEx
Safety of Rivaroxaban vs SOC for acute DVT treatment
(N=5,142)
Completed
and reported
Meet Management in Cologne • September 20, 2016Page 27
NAVIGATE ESUS
Embolic Stroke of Undetermined Source Study
Study title: Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in
Patients With Recent Embolic Stroke of Undetermined Source (ESUS)
www.clinicaltrials.gov/ct2/show/NCT02313909
Objective: Efficacy of Rivaroxaban in reducing the risk of recurrent stroke and systemic embolism in patients
with a recent Embolic Stroke of Undetermined Source (ESUS)
Short design: Multicentre, randomized, double-blind,
double-dummy, active-comparator, event-driven,
superiority study
Indication: Secondary
stroke prevention in
ESUS
Start: Q4’2014
Completion: End 2017e
30 days
Safety
Follow-up
Rivaroxaban 15 mg od
ASA 100 mg od Efficacy
Cut-off Date
Study
End
Event-driven study
N~7,000
1:1
Day 1
R
Total study duration: ~3 years
Mean treatment duration per patient: ~2 years
Population:
Patients with recent
embolic stroke of
undetermined source
Meet Management in Cologne • September 20, 2016Page 28
NAVIGATE ESUS
Study Details
# including but not limited to; ‡ any other exclusion criteria in conjunction with the local product information
and any other contraindication listed in the local labelling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/ct2/show/NCT02313909
• Composite of Stroke (ischemic,
hemorrhagic, and undefined stroke,
transient ischemic attack with positive
neuroimaging) and Systemic embolism
Primary efficacy endpoint
• Patients with recent ischemic stroke and
• Stroke not being lacunar
• No cervical carotid atherosclerosis
• No AF
• No intracardiac thrombus
• No other specific cause of stroke
Key inclusion criteria#
• ISTH major bleeding
Primary safety endpoint
• Severe disabling stroke
(modified Rankin score ≥4 at screening)
• CrCl <30 ml/min
• Indication for chronic anticoagulation
or antiplatelet therapy
Key exclusion criteria‡
Meet Management in Cologne • September 20, 2016Page 29
PIONEER AF-PCI
PCI Study
Study title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban
and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo
Percutaneous Coronary Intervention
Objective: Safety of two Rivaroxaban regimens versus VKA after PCI (with stent placement) in non-valvular AF
Rivaroxaban 15 mg od*# + Clopidogrel
VKA (INR 2.0–3.0)§
+ DAPT‡
N=2,100
1:1:1
R
Population:
Paroxysmal, persistent or
permanent AF, undergoing
PCI (with stent placement)
Rivaroxaban 2.5 mg bid#
+ DAPT‡
Rivaroxaban 15 mg od*
+ low-dose ASA
VKA + low-dose ASA
End of treatment
(12 months)
Short design:
Open-label, randomized, multicenter study
Indication: SPAF/ACS
Start: Q2’13
Completion: End 2016e
* CrCl 30–49 ml/min: 10 mg od; # first dose 72–96 hours after sheath removal; ‡ ASA (75–100 mg daily) + Clopidogrel (75 mg daily)
(alternative use of Prasugrel or Ticagrelor allowed, but capped at 15%); § first dose 12–72 hours after sheath removal; Gibson CM et al. AHJ 2014;
www.clinicaltrials.gov/ct2/show/NCT01830543
Meet Management in Cologne • September 20, 2016Page 30
PIONEER AF-PCI
Study Details
* Including but not limited to; # any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the
local labeling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/ct2/show/NCT01830543; Gibson CM et al. AHJ 2014
• Composite of TIMI major bleeding events, minor bleeding events and bleeding events requiring
medical attention
Primary endpoint
• History of paroxysmal, persistent or permanent
non-valvular AF
• Undergone PCI (with stent placement) for
primary atherosclerotic disease
Key inclusion criteria*
• Prior stroke / TIA
• Suspected or documented stent thrombosis
during the index procedure or
• has a PCI with stent placement for a pre-
viously stented lesion (stent within a stent)
during the index procedure or within the
previous 12 months
• Incomplete staged PCI procedure
• CrCl <30 ml/min
• Concomitant use of other anticoagulants
Key exclusion criteria#
Meet Management in Cologne • September 20, 2016Page 31
COMPASS
CAD/PAD Study
Study title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients
With Coronary or Peripheral Artery Disease (COMPASS – Cardiovascular OutcoMes for People Using Anticoagulation
StrategieS)
Short design:
Randomized, double-blind, controlled trial
Indication: CAD/PAD
Start: Q2’13
Completion: early 2018e
* Patients treated according to local standard of care; # ≤30 days of the required pre-specified number of events having occurred;
www.clinicaltrials.gov/show/NCT01776424
Objective: Efficacy and safety of Rivaroxaban, low-dose Rivaroxaban plus ASA or ASA alone for reducing risk of MI,
stroke or cardiovascular death in CAD or PAD
Rivaroxaban 2.5 mg bid + ASA 100 mg od
± pantoprazole 40 mg od
ASA 100 mg od
± pantoprazole 40 mg od
N~27,000
1:1:1
RPopulation:
Documented CAD or PAD
Rivaroxaban 5.0 mg bid
± pantoprazole 40 mg od
Final
washout
period visit
30-day
washout
period*
Final
follow-up
visit#
30-day run-in
ASA 100mg
Meet Management in Cologne • September 20, 2016Page 32
COMPASS
Study Details
# including but not limited to; ‡ any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the
local labeling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/show/NCT01776424
• Composite of MI, stroke or
cardiovascular death
Primary efficacy endpoints
• CAD or PAD plus ≥1 of:
• Age ≥65 years
• Age <65 years plus atherosclerosis in
≥2 vascular beds or ≥2 additional risk
factors
Key inclusion criteria#
• Modified ISTH major bleeding
Primary safety endpoint
• Stroke ≤1 month or any haemorrhagic
or lacunar stroke
• Severe HF with known ejection fraction
<30% or NYHA class III or IV symptoms
• eGFR <15 ml/min
• Concomitant use of other anticoagulants
• Chronic treatment with non-ASA
antiplatelet therapy
Key exclusion criteria‡
Meet Management in Cologne • September 20, 2016Page 33
COMMANDER HF
Chronic HF/CAD Study
Study title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral
Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Chronic Heart
Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure
Short design: Randomized, double-blind, placebo-
controlled, parallel-group, multicenter, event-driven,
superiority study
Indication: HF/CAD
Start: Q3’13
Completion: 1H 2018e
* Date when 984 primary efficacy outcome events have occurred;
www.clinicaltrials.gov/ct2/show/NCT01877915; study sponsor: Janssen Research & Development, LLC; Zannad F et al., Eur J Heart Fail 2015
Objective: Efficacy and safety of Rivaroxaban for reducing the risk of MI, stroke or death in HF with CAD
Rivaroxaban 2.5 mg bid
(single or dual antiplatelet therapy)
Placebo
(single or dual antiplatelet therapy)
N=5,000
R
Population:
HF and CAD after recent
hospitalization
End
of study
visit
15–45-day
follow-up
Global
treatment
end date*
~6–30 months
• Fatal bleeding, critical organ bleeding
with potential for permanent disability
• Composite MI, stroke or all-cause death
Meet Management in Cologne • September 20, 2016Page 34
COMMANDER HF
Study Details
* Including but not limited to; # any other exclusion criteria in conjunction with the local product information and
any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/ct2/show/NCT01877915; study sponsor: Janssen Research & Development, LLC; Zannad F et al., Eur J Heart Fail 2015
Primary efficacy endpoint
• Symptomatic CHF ≥3 months and
hospitalized for exacerbation of CHF
• LVEF ≤40% ≤1 year
• Significant CAD
• Stable HF at randomization
• Treatment according to guidelines
Key inclusion criteria*
Primary safety endpoint
• Prior stroke ≤3 months
• Index hospitalization >21 days
• Planned intermittent outpatient
treatment with positive inotropic drugs
administered intravenously
• Concomitant use of other
anticoagulants
Key exclusion criteria#
Objective: Efficacy and Safety of Rivaroxaban for the Reduction of Thrombotic Vascular Events in Subjects with PAD
Undergoing Peripheral Revascularization Procedures
Meet Management in Cologne • September 20, 2016Page 35
VOYAGER PAD
PAD Study
Study title: Rivaroxaban in a randomized, double blind, event driven superiority trial to show a significant reduction in
thrombotic vascular events in patients with peripheral artery disease (PAD)
Short design: Randomized, multicenter, prospective,
double-blind, double-dummy, parallel-group,
placebo-controlled, event-driven
Indication: PAD
Start: Q2’2015
Completion: early 2019e
www.clinicaltrials.gov/ct2/show/NCT02504216
Rivaroxaban 2.5 mg bid + ASA 100 mg od
ASA 100 mg od
N~6,500
1:1
R
Population: Patients
with symptomatic PAD
undergoing peripheral
revascularization
Study
End
30 days
Safety
Follow-up
Efficacy
Cut-off Date
Day 1
Event-driven
study
Mean treatment duration per patient:
~30 months
Meet Management in Cologne • September 20, 2016Page 36
VOYAGER PAD
Study Details
* Including but not limited to; # any other exclusion criteria in conjunction with the local product information
and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/ct2/show/NCT02504216
• Composite of myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death,
acute limb ischemia (ALI), and major amputation of a vascular etiology
Primary endpoint
• Both genders, age ≥50 years
• Documented moderate to severe symptomatic
lower extremity peripheral artery occlusive
disease
• Technically successful peripheral infra-inguinal
revascularization for symptomatic PAD within
the last 7 days prior to randomization
Key inclusion criteria*
• Prior revascularization on the index leg within
8 weeks of the qualifying revascularization
• Planned post-procedural co-administration
of thienopyridines in addition to ASA
(exc. Clopidogrel ≤30 days for the qualifying
revascularization)
• Confirmed ACS within the last 30 days
• Any medically documented history of
intracranial hemorrhage, stroke, or transient
ischemic attack (TIA)
Key exclusion criteria#
Meet Management in Cologne • September 20, 2016Page 37
GEMINI ACS 1
ACS Study with Single vs. Dual APs
Study title: A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or
Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Short design: Multicentre, prospective, randomized,
double-blind, double-dummy, active-controlled,
parallel-group study
Indication: ACS
Start: Q2’2015
Completion: End 2016e /
early 2017e
Objective: Safety of Rivaroxaban in addition to either Clopidogrel or Ticagrelor in ACS
www.clinicaltrials.gov/ct2/show/NCT02293395; study sponsor: Janssen Research & Development, LLC
Population:
Diagnosis of
ACS
1:1
Clopidogrel + Rivaroxaban 2.5 mg BID
Clopidogrel + ASA
30-day
follow-up
180–360 days
treatment
SOC
SOC
R
1:1
Ticagrelor + Rivaroxaban 2.5 mg BID
Ticagrelor + ASA
30-day
follow-up
180–360 days
treatment
SOC
SOC
R
Index hospi-
talization:
1.Acute
treatment:
invasive or
medical
management
2.Maintenance
dose ASA
and P2Y12
inhibitor
(Clopidogrel,
Ticagrelor)
Clopidogrel
+ ASA
N=1,500
N=1,500
Ticagrelor
+ ASA
≤ 24h
Meet Management in Cologne • September 20, 2016Page 38
GEMINI ACS 1
Study Details
* including but not limited to; # any other exclusion criteria in conjunction with the local product information
and any other contraindication listed in the local labelling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/ct2/show/NCT02293395; study sponsor: Janssen Research & Development, LLC
• Thrombolysis in Myocardial Infarction (TIMI) clinically significant bleeding
Primary endpoint
• Diagnosis of ACS
• Acute treatment for ACS
• Maintenance of dual antiplatelet
treatment with either Clopidogrel plus
ASA, or Ticagrelor plus ASA
• Younger than 55 years of age must also
have either diabetes mellitus, or a prior
MI
Key inclusion criteria*
• Prior stroke of any etiology or TIA
• Anticipated need for chronic
administration of proton pump inhibitors
(PPI) Omeprazole or Esomeprazole
concomitantly with Clopidogrel. Other
PPIs are allowed
• Participant who received thrombolytic
therapy as treatment for the index ACS
event cannot be enrolled in the
Ticagrelor stratum
Key exclusion criteria#
Meet Management in Cologne • September 20, 2016Page 39
EINSTEIN CHOICE
Long-Term Secondary VTE Prevention Study
Study title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of
Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary
Embolism
* Completed 6–12 months (±1 month) with interruption of anticoagulation ≤1 week at randomization;
www.clinicaltrials.gov/ct2/show/NCT02064439; Weitz JI et al. Thromb Haemost 2015
Objective: efficacy and safety of reduced-dosed rivaroxaban, standard-dosed rivaroxaban versus ASA for the long-term
secondary prevention of recurrent symptomatic VTE in patients with symptomatic DVT and/or PE
Rivaroxaban 20 mg od
N~950
N~950
N~3,300
R
Population:
DVT and / or PE
after 6–12 months
of anticoagulation*
Rivaroxaban 10 mg od
N~950
1 month
observation
period
12-month treatment duration
Day 1
Short design: Multicentre, randomized, double-blind,
double-dummy, active-comparator, event-driven,
superiority study
Indication: VTEx
Start: Q1’2014
Completion: End 2016e
ASA 100 mg od
• Major bleeding*• Fatal/non-fatal symptomatic recurrent
VTE
Meet Management in Cologne • September 20, 2016Page 40
EINSTEIN CHOICE
Study Details
* Bleeding definition – see notes; # including but not limited to; ‡ any other exclusion criteria in conjunction with the local product information
and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered;
www.clinicaltrials.gov/ct2/show/NCT02064439; Weitz JI et al. Thromb Haemost 2015
Primary efficacy endpoint
• Patients with confirmed symptomatic
DVT and/or PE treated for
6–12 months (interruption ≤1 week)
Key inclusion criteria#
Primary safety endpoint
• Life expectancy <6 months
• Legal lower age limitations
(country specific)
• CrCl ≤30 ml/min
• Concomitant use of other anticoagulants
• Chronic treatment with antiplatelet
therapy
Key exclusion criteria‡
Meet Management in Cologne • September 20, 2016Page 41
FXla Inhibition – Exploring a Novel Approach
For Anti-Thrombotic Therapy
Vessel
wall
injury
Tissue
Factor
Factor
Xa
Amplification
Thrombin
Risk for
vessel occlusion
= Thrombosis
Vessel injury
coverage
= Hemostasis
FXIa
FXIa inhibition
blocks thrombosis,
but not hemostasis
• FXI pathway inhibition may have potential for antithrombotic therapy without
increased bleeding risk
• FXI pathway inhibition may offer an additional pathway for treating patients
for whom there are currently no suitable therapeutic options available
Meet Management in Cologne • September 20, 2016Page 42
Investigating New Approaches in
Anticoagulation via FXI / FXIa Inhibition
1) In-licensed from IONIS-Pharmaceuticals
2) Prevention of thrombosis in patients undergoing total knee arthroplasty; Büller et al., NEJM (2015)372; 232
FXIRX Antisense Drug Candidate
IONIS FXI
200 mg
IONIS FXI
300 mg
Enoxaparin
40 mg
• Antisense oligonucleotide1 that specifically reduces
the biosynthesis of clotting factor XI
• Positive Phase II data2
Fully human IgG Anti-FXIa Antibody
• 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 without affecting bleeding times
• Status preclinical
Meet Management in Cologne • September 20, 2016Page 43
Finerenone – Opportunity to Lead in
Diabetic Kidney Disease
DKD: diabetic kidney disease; CKD chronic kidney disease; MRA: mineralocorticoid receptor antagonist
• Finerenone is a novel non-steroidal
MRA with a differentiated profile
• Steroidal MR antagonists are not
approved for kidney diseases
• A Finerenone phase IIb (ARTS-DN)
study in Diabetic Nephropathy was
successfully completed
Finerenone
 Significant need for innovative therapies
 Phase III program in DKD progressing as planned
• Market for chronic kidney disease
estimated at ~$14bn in 2024
• Resulting complications from Diabetes
accounting for 35% of CKD
• ~40% of new cases of end-stage renal
disease (ESRD) are due to Diabetes
Mellitus (DM)
• Patients with Type II DM and CKD are at
high risk of cardiovascular (CV) death
Diabetic Kidney Disease
Meet Management in Cologne • September 20, 2016Page 44
Finerenone – Phase III Program
2 Event-Driven Outcome Trials
Diabetic Kidney Disease
• Type II Diabetes and CKD
• DKD with high risk of developing
CV events
• Primary cardiovascular endpoint
FIGARO-DKD
• Type II Diabetes and CKD
• DKD with high risk of progression
of CKD and developing CV events
• Primary renal endpoint
FIDELIO-DKD
DKD: diabetic kidney disease; CKD chronic kidney disease; CV: cardiovascular
• FInerenone in reducing kiDnEy faiLure and
dIsease prOgression in DKD
• N~4,800
• Primary EP: composite of kidney failure,
decrease of eGFR ≥40% from baseline or
renal death
Meet Management in Cologne • September 20, 2016Page 45
Finerenone – Phase III FIGARO-DKD and
FIDELIO-DKD Trial – Design
• FInerenone in reducinG cArdiovascular
moRtality and mOrbidity in DKD
• N~6,400
• Primary EP: composite of CV death or
non-fatal CV events
FIGARO-DKD FIDELIO-DKD
Meet Management in Cologne • September 20, 2016Page 46
Vericiguat – Potential First-in-Class Treatment
for Chronic Heart Failure
• A lack of sGC stimulation leads to the reduced activity of the “nitric oxide-
sGC-cGMP” pathway, causing coronary dysfunction and progressive
myocardial damage
• By directly stimulating the critical enzyme sGC, Vericiguat restores this
pathway and in turn may improve heart and vascular function
• Phase III (VICTORIA) trial assesses a potential reduction in mortality and
morbidity on top of standard of care in HFrEF patients
• VICTORIA trial initiated1
1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic heart failure;
HFrEF: heart failure with reduced ejection fraction
Novel approach targeting the critical cGMP cardiovascular
pathway that is impaired in CHF patients
Meet Management in Cologne • September 20, 2016Page 47
Vericiguat –
Phase III Study Design (VICTORIA)
Study objective: A randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of
Vericiguat in participants with HFrEF. The primary hypothesis is Vericiguat is superior to placebo in increasing the time to
first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with
HFrEF.
HFrEF heart failure with reduced ejection fraction;
www.clinicaltrials.gov/ct2/show/NCT02861534; study sponsor: Merck Sharp & Dohme Corp
Starting dose of 2.5 mg taken orally once daily
with food, on a background of standard of care.
Dose will be uptitrated to 5 mg and to 10 mg
R
Population:
Subjects with
heart failure
with reduced
ejection fraction
Day 1
Starting dose of placebo equivalent to 2.5 mg
taken orally once daily with food, on a background
of standard of care. Dose will be sham uptitrated
to 5 mg and to 10 mg placebo equivalent
Primary
End Point:
Time to First
Occurrence
of Composite
Endpoint of
Cardiovascular
(CV) Death or
Heart Failure
Hospitalization
VICTORIA: VerICiguaT glObal study in patients with heart failure and Reduced ejectIon frAction trial
Study conducted in partnership with the Canadian VIGOUR Centre (CVC) at the University of Alberta
and the Duke Clinical Research Institute (DCRI).
Vericiguat
Placebo
Study
End
Event-driven study
N~4,900
Meet Management in Cologne • September 20, 2016Page 48
Proven Track Record of Successful
Portfolio ManagementSummary
Page 48 Meet Management Cologne • September 20, 2016
Leading
Hemophilia
Franchise
Meet Management in Cologne • September 20, 2016Page 49
Modulating Hemostatic Balance in Hemophilia
Bleeding Clotting
In hemophilia and other bleeding disorders, clotting can be enhanced by:
• Increase in procoagulant factors, e.g. factor VIII supplementation
• Decrease in anticoagulant factors, e.g. inhibition of TFPI
(Tissue Factor Pathway Inhibitor)
Anticoagulant
Factors
Procoagulant
Factors
Meet Management in Cologne • September 20, 2016Page 50
Robust Innovation Pipeline in Hemophilia and
Bleeding Disorders
Kogenate
Kovaltry
(first launches in Q1–2016)
Bay 94-9027 Damoctocog Alfa Pegol
(long acting FVIII)
Phase I Phase II Phase III Filed MarketedPreclinical
FVIII supplementation
Novel MoA
Gene Therapy (Collaboration with Dimension Therapeutics)
Anti-TFPI Antibody Bypass Therapy
MoA: mode of action
TFPI: tissue factor pathway inhibitor
Meet Management in Cologne • September 20, 2016Page 51
Kovaltry – Initial Launch Shows Positive
Response in EU, US and Japan
• Kovaltry is an improved full-length
rFVIII product allowing for
prophylaxis treatment with as few
as 2 per week application
• Successfully launched in US,
Canada, Japan as well as
Germany and other EU markets
during 1H’16
• Initial launch KPIs are positive with
Kovaltry being chosen by both
Kogenate and competitive brand
customer for its efficacy and trust
Meet Management in Cologne • September 20, 2016Page 52
TFPI-Inhibition as a Potential Novel Treatment
Principle for Hemophilia A/B
Role of TFPI in Coagulation anti-TFPI Facts
• Can reversibly inhibit various
clotting factors leading to bleeding
• Inhibition of TFPI potentially offers
novel treatment option for
Hemophilia A/B patients with or
without inhibitors
• Hemophilia patients depend on extrinsic
pathway for clotting. anti-TFPI Ab inhibits
TFPI – thereby restoring impaired
hemostasis
• BAY1093884 is a fully human
monoclonal antibody
• Phase I ongoing
TFPI: tissue factor pathway inhibitor
Meet Management in Cologne • September 20, 2016Page 53
Proven Track Record of Successful
Portfolio ManagementSummary
Page 53 Meet Management Cologne • September 20, 2016
Well Positioned
In Retinal
Diseases
Meet Management in Cologne • September 20, 2016Page 54
Well-Positioned in Retinal Diseases
1: marketed by Bayer ex-US only
2: source: IMS monthly market share data
3: in collaboration with Regeneron
DME: Diabetic macula edema; mCNV: myopic Choroidal neovascularization; RVO: retinal vein occlusion; PDGFR: platelet-derived growth factor
• Eylea1 gaining market share in multiple countries, achieving market
leadership across the ex-US territories2
• Confident in growth potential – peak sales estimates raised to > €2.5bn
• Life-cycle management including combination therapy with either
PDGFR-β antibody3 or Ang2-antibody3
Meet Management in Cologne • September 20, 2016Page 55
Eylea and PDGFR-ß-Antibody or Ang2-
Antibody - Combination Therapy
1) In collaboration with Regeneron; 2) Kudelka et al. Exp Rev Ophthalmol.2013; 8(5):475-484; 3) Diago et al. Mayo Clin. Proc.2008; 83, 231-234;
PDGF(R): platelet-derived growth factor (receptor); Ang2: angiopoietin 2
Eylea and a PDGFR-ß antibody co-formulation in wet AMD
• Program currently in phase II1
• PDGF may induce maturation of pathological neovascularization
through pericyte stimulation; showed experimentally to recruit pro-
fibrotic cells in the eye and may therefore have a role in retinal
scarring secondary to wet AMD2
• PDGF inhibition can potentially augment efficacy of VEGF
inhibition in wet AMD3
Eylea and Ang2-antibody co-formulation in wet AMD and DME
• 2 ongoing phase II programs1 evaluating the combination of co-formulated Eylea with
the Ang2-antibody nesvacumab
• Ang2 together with VEGF have the potential to influence pathological development of
new blood vessels and the permeability of blood vessels in certain eye diseases
Meet Management in Cologne • September 20, 2016Page 56
Proven Track Record of Successful
Portfolio ManagementSummary
Page 56 Meet Management Cologne • September 20, 2016
Striving for
Segment
Leadership in
Oncology
Meet Management in Cologne • September 20, 2016Page 57
Stivarga - Oral Multikinase Inhibitor with
Distinct Profile
Regorafenib is an oral multikinase inhibitor with a distinct profile targeting
• Angiogenic (VEGFR1-3, TIE2)
• Stromal (PDGFR-, FGFR)
VEGFR: vascular endothelial growth factor receptor; TIE2: tyrosine kinase with immunoglobulin-like and EGF-like domains;
PDGFR: platelet derived growth factor receptor; FGFR: fibroblast growth factor receptor
• Oncogenic (KIT, PDGFR and RET)
receptor tyrosine kinases
Inhibition of proliferation
of certain tumor cells
Inhibition of
stromal signalling
Inhibition of
neoangiogenesis
Meet Management in Cologne • September 20, 2016Page 58
Stivarga - Oral Multikinase Inhibitor with
Distinct Profile
• Stivarga is approved* in:
• >90 countries for metastatic colorectal cancer (mCRC) and in
• >80 countries for advanced gastrointestinal stromal tumors (GIST)
• Plan to file Regorafenib for 2L HCC in 2016
• Ongoing clinical development activities include
• Phase III study in adjuvant CRC (ARGO study)
* as of September 2016
HCC: hepatocellular cancer; (m)CRC: (metastatic) colorectal cancer
Meet Management in Cologne • September 20, 2016Page 59
Stivarga
Phase III Data 2L HCC*
• RESORCE study met primary endpoint demonstrating that Regorafenib
led to a stat. significant and clinically meaningful improvement in overall
survival for patients with HCC who progressed on prior Nexavar
treatment:
• 38% reduction in the risk of death (HR 0.62; 95% CI 0.50-0.78; P <0.001)
• Median OS 10.6 months vs. 7.8 months
• Survival benefit was maintained in all predefined subgroups
• PFS and TTP were significantly improved with Regorafenib
• Patients treated with Regorafenib had significantly higher response rate
and almost doubled disease control rate
• Adverse events were manageable and consistent with the known
Regorafenib safety profile
* Bruix J. et al. presented at World Congress on Gastrointestinal Cancer 2016
HCC: hepatocellular cancer; OS: overall survival; HR: hazard ratio; PFS: progression free survival; TTP: time to progression
Meet Management in Cologne • September 20, 2016Page 60
Expanding Xofigo’s Position in Castration-
Resistant Prostate Cancer Treatment
For details on approved indications see respective product labels;
Zytiga® is a trademark of Johnson & Johnson
Metastatic castration-resistant prostate cancer
Asymptomatic bone metastases
Potential new disease area
for combination therapy
Symptomatic bone metastases
Xofigo
(radium Ra 223 dichloride injection)
Novel antihormonal agents
(eg. Zytiga® [abiraterone])
Chemotherapy
• Combination therapy with abiraterone, an inhibitor of testosterone synthesis
• Expansion to earlier disease stages enhances accessible patient population
• A delay of skeletal-related events is of major clinical importance
Meet Management in Cologne • September 20, 2016Page 61
Addressing Multiple Life-Cycle Opportunities
for Radium-223 Dichloride (Xofigo)
CRPC: castration resistant prostate cancer
Life-cycle opportunities Addressed through
Phase II trial assessing the short and
long-term safety of re-treatment
Phase II trial with dose higher than
the approved 50 kBq/kg
Clinical studies in breast cancer,
osteosarcoma, multiple myeloma and
potentially other cancer types
Phase III combination trial
with Abiraterone
Phase III trial in combination
with Enzalutamide
Repeat dosing in CRPC
Higher dose in CRPC
Expansion into additional
cancer types
Earlier disease stages of CRPC
Combination studies in CRPC
Meet Management in Cologne • September 20, 2016Page 62
Anetumab Ravtansine Program Advancing
* Blumenschein et al. ASCO 2016; ADC: antibody drug conjugate
Mode of action:
• ADC targeting tumor-associated antigen
mesothelin, and delivering toxophore DM4,
which acts on proliferating cells (tubulin
inhibitor)
Potential spectrum of indications
determined by mesothelin expression
pattern:
• mesotheliomas (100%)
• pancreatic cancer (~80-100%) and
• ovarian adenocarcinomas (~80%)
Clinical program:
• Phase I* with promising results including
duration of treatment of > 1,000 days
• Registrational phase II in metastatic pleural
mesothelioma ongoing
Meet Management in Cologne • September 20, 2016Page 63
Anetumab Ravtansine – Promising Profile
Shown in Phase I*
* Blumenschein et al; ASCO, 2016;
PR: partial response; Q3W: three times per week; ORR: overall response rate; TEAE: treatment emergent adverse event; AE: adverse event
• Single-agent anetumab ravtansine administered at 6.5 mg/kg Q3W
to patients with advanced refractory solid tumors resulted in:
• PRs in 7 patients (5 of 16 with mesothelioma [31% ORR] and 2 of 21
with advanced ovarian cancer [9.5% ORR])
• An acceptable safety profile; the most common drug-related TEAEs
included fatigue, gastrointestinal AEs, ophthalmological AEs,
peripheral neuropathy and elevated serum transaminases
 A pivotal phase II trial for second-line therapy
in metastatic pleural mesothelioma is ongoing
Meet Management in Cologne • September 20, 2016Page 64
Anetumab Ravtansine – Phase II Design
Study design
• Randomized, open-label, active-controlled, two-arm, multicenter, Phase II trial
(NCT02610140) to evaluate the safety and efficacy of single-agent Anetumab
Ravtansine
Patient selection criteria
• Biomarker sampling on all patients at pre-screening; mesothelin expression
levels need to exceed a predetermined threshold value
• ODM-201 is a potent and full AR antagonist
• Promising efficacy profile demonstrated in previous studies
• Inhibits growth of prostate cancers in preclinical studies
• Significantly decreases PSA levels in patients with progressive CRPC
• Sustained PSA reduction was observed at higher dose levels
• ODM-201 antagonizes mutant ARs linked to resistance to other AR antagonists
(ie, bicalutamide, enzalutamide)
• Phase III program ongoing addressing
i. hormone sensitive metastatic prostate cancer
ii. non-metastatic CRPC
Meet Management in Cologne • September 20, 2016Page 65
ODM-201 – A Novel, New-Generation
Nonsteroidal AR Antagonist
AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen
Meet Management in Cologne • September 20, 2016Page 66
Expanding Positioning in Prostate Cancer
AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen; EBRT: external beam radiation therapy;
ADT: androgen deprivation therapy; LHRH: luteinizing hormone-releasing hormone
NON-METASTATIC (St I-III):
~10–15 years
METASTATIC (St IV):
~2–4 years
M0
Local
disease
M0
Untreated
Rising PSA
M0
Treated
Biochemical
relapse
Rising PSA
Newly
diagnosed
metastases
CRPC
Asympto-
matic
disease
(failed ADT)
CRPC
Sympto-
matic
disease
CRPC
Post-
docetaxel
Surgery
± EBRT
LHRH ADT
ADT* /
Chemo
Novel
Anti-Androgens
Sipuleucel-T Chemotherapy
XofigoStudies
ARAMIS ARASENS
Meet Management in Cologne • September 20, 2016Page 67
ODM-201 May Differentiate Through
Low Blood-Brain Barrier Penetration
* Rat autoradiography (QWBA) confirms brain/plasma ratio of 14C-ODM-201 related radioactivity was 0.04–0.06, indicating negligible penetration
to the brain; † 14C-Abiraterone concentration measured in brain was 5–9 times higher than its concentration in blood and has been measured
in cerebellum, cerebrum, medulla, and spinal cord 4) ‡ Clegg et al, Cancer Research. 2012;72:1494-1503; Foster, et al. The Prostate. 2011;71:480-488
1) Fizazi, et al. Lancet Oncol. 2014;15:975-985; 2) Moilanen, et al. Eur J Cancer. 2013;49(suppl 2);abst. 2869.; 3) Moilanen, et al. Sci Rep. 2015;5:12007.
DOI: 10.1038/rep12007.; 4) European Medicines Agency Assessment Report for Zytiga
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002321/WC500112860.pdf
• ODM-201 demonstrates negligible blood-brain barrier penetration in preclinical studies1-3
• ODM-201 has a low brain/plasma ratio in murine models3*
• Reduced brain exposure may confer a lower risk of seizure with ODM-201 treatment than
ARN-509 or enzalutamide1-3
Enzalutamide
19%‡
ARN-509
29%‡
ODM-201 + main
metabolite 3%*
Abiraterone†
Meet Management in Cologne • September 20, 2016Page 68
ARAMIS
Phase III of ODM-201 in nmCRPC
nmCRPC: non-metastatic castration-resistant prostate cancer; PSA=prostate-specific antigen; MFS: metastasis free survival
• Preventing the development of metastases in men with nmCRPC is a major unmet medical need,
and preclinical and early-stage clinical studies suggest that ODM-201 is an effective and
generally well-tolerated therapy
• ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) is a phase 3 clinical
trial examining the safety and efficacy of ODM-201 in men with nmCRPC at high risk for
metastasis to determine if ODM-201 delays time to metastasis
Study Design
High-risk
nmCRPC
men
Randomize
Metastasis-free survival
(primary endpoint)
ODM-201
600 mg twice daily
Placebo
2:1
Double-blind
N~1,500
Stratification:
PSADT (≤6 mo vs. >6 mo)
Use of osteoclast-targeted therapy
at time of enrollment: yes vs. no
Meet Management in Cologne • September 20, 2016Page 69
ARASENS
Phase III of ODM-201 in mHSPC
mHSPC: metastatic hormone sensitive prostate cancer; AR: androgen receptor; ADT: androgen deprevation therapy;
OS: overall survival; mCSPC: metastatic castration sensitive prostate cancer; ULN: upper limit of normal
• ADT and docetaxel have recently demonstrated significant survival benefits with tolerable
toxicities and is anticipated to become a new standard for subjects with mCSPC
• The aim of the proposed study is to demonstrate that the addition of ODM-201 as second
generation AR inhibitor to ADT and docetaxel chemotherapy significantly prolongs OS over
placebo in mCSPC subjects
Key Eligibility Criteria:
• Metastatic prostate cancer
• ADT started < 12 weeks
before randomization
(but no longer)
• Candidates for ADT and
docetaxel
• ECOG 0-1
1:1
randomization
Primary endpoint:
OS
ODM-201 600mg bid
w/ ADT + docetaxel
Placebo
w/ ADT + docetaxel
N=1,300
Stratification:
Extent of disease
• Non-regional lymph node metastasis only
• Bone metastasis with or without lymph node metastasis
• Visceral metastasis with or without lymph node
or with or without bone metastasis
Alkaline phosphatase
• < ULN
• ≥ ULN
Meet Management in Cologne • September 20, 2016Page 70
Proven Track Record of Successful
Portfolio ManagementSummary
Page 70 Meet Management Cologne • September 20, 2016
Pipeline
Overview
Meet Management in Cologne • September 20, 2016Page 71
Pharma Pipeline With Attractive Assets
in Areas of High Unmet Medical Need
Selection of projects
Erica Mann, Member of the Board of Management, Head of Consumer Health
Investor Presentation – Consumer Health
Meet Management in Cologne – September 20, 2016
Meet Management in Cologne • September 20, 2016Page 2
Significant Pace of Change in
the Self Care Market
Aging & more educated population
Consumer desire for healthcare
empowerment and self care
Expanding access via new
geographies and channels
Government / private sector
desire to lower healthcare costs
Rx-to-OTC switches
Meet Management in Cologne • September 20, 2016Page 3
Consumer Health Advocating Self Care
Education Risk Awareness
● Epidemiology
● Clinical picture
● Ways to address
● Publications
● Clinical Research
● Conferences
● Advocacy groups
● Organizations
● Jointly establish self care
recommendations
Alliances
Meet Management in Cologne • September 20, 2016Page 4
History of Building Scale and Scope
Organically and through Acquisitions
BRC1 countries (2012-present)
• Investments in organic
growth
MCC (2014)4
• US #1 position
• Enter Allergy (leader),
Suncare, Footcare
Dihon (2014)
• China #2 MNC position
• Foothold into TCM3
Steigerwald (2013)
• Naturals
• Strengthen GI2
• International rollout
Iberogast
Roche (2005)
• Europe
• Strengthen Nutritionals,
Derm
Topsun (2008)
• China infrastructure in retail
and production
Sagmel (2008)
• CIS infrastructure
2004 2015
Sales €1.4bn €6.1bn
Global
Position
#6 #16
Block-
buster
Brands5
3 16
Sources: internal data, Nicholas Hall / IRI
1 Brazil, Russia, China; 2 Gastrointestinal; 3 Traditional Chinese Medicine; 4 Merck & Co Consumer-Care;
5 over €100m annual sales; 6 OTC plus Suncare and Footcare; CIS: commonwealth of independent states; MNC: multinational companies
3.4 3.5
3.9 3.9
4.2
6.1
3.1
2010 2011 2012 2013 2014 2015 1H
2016
Meet Management in Cologne • September 20, 2016Page 5
Successfully Executed Growth Strategy
 Outperformed market growth
2010-15
 Acquisition of Merck’s
Consumer Care business
builds scale and scope in key
geographies and categories
 1H 2016 affected by sales
decline in US, soft seasons
and macroeconomic slowdown
in key emerging markets
OTC market:
4.4% CAGR*
Consumer Health sales
€ billion; ∆% Fx & portfolio adjusted
+7%
+6%
+4%
+5%
+6%
+3%
1H 2016
*Source: Nicholas Hall
Sales ∆ Fx & portfolio adjusted
Meet Management in Cologne • September 20, 2016Page 6
FY 2016 Guidance Adjusted
2015
2016
(Update July)
Sales €6.1bn
Low- to mid-single-digit
% increase to ~ €6bn
EBITDA
before special items
€1.5bn Level with prior year
Assuming end Q2 2016 Fx rates (USD 1.11); outlook depends on specific planning assumptions as detailed in the annual report
Meet Management in Cologne • September 20, 2016Page 7
Mid-Term Aspirations 2018
2015 Aspiration 2018
Sales
+6.1% to
€6.1bn
4-5% CAGR (2015-2018)
Adj. EBITDA margin 24.0% ~25%
Sales ∆ Fx & portf. adjusted, EBITDA before special items
Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
 Digital / E-commerce
 Customer excellence
 Establish CH as a leader in consumer-centric
innovation (e.g. pursue Rx-to-OTC switch)
 Improve efficiency and effectiveness
 Apply proven brand building excellence
 Focus on well recognized brands and attractive
categories
 Drive performance in US
 Address slowdown in key emerging markets
Meet Management in Cologne • September 20, 2016Page 8
Best Positioned to Sustain Market Share
Growth While Improving Profitability
Build category
leading brands
Drive key
market growth
Accelerate
innovation
Enhance
capabilities
Meet Management in Cologne • September 20, 2016Page 9
US: Focus on Core Brands to Drive Growth
US OTC market CH performance
 Size €29bn (#1 OTC market globally)
 ~3.0% 5-year CAGR
 Recent market growth driven by Rx-to-OTC
switches and relaunches
 #1 position, 9.7%* market share
 €2.5bn 2015 net sales
 2.5% 5-year CAGR in-market sales
CH current situation / challenges
 Achieved market leadership with enviable
portfolio of leading brands
 Reinvestment in Coppertone and Dr. Scholl‘s
 Soft cough, cold, allergy and start to sun
seasons
 Competitive reentry and activity
CH execution plans
 Extend innovation across broader
range of activities, e.g. new channels,
adjacencies
 Turn around Coppertone and Dr. Scholl’s
 Build on strong momentum on Claritin,
Miralax, One A Day
* Source: IRI including OTC plus Sun and Foot Care
Meet Management in Cologne • September 20, 2016Page 10
Increase Profitability in Key Emerging Markets
China Russia
 Market size €20bn (#2 OTC market)
 CH achieved critical mass in 5 years
(€88m in 2011 to €346m in 2015)
 OTC market slowing down to
~6% growth p.a. 2016-20
 Market size €3bn (#6 OTC market)
 Scaled up from zero to €228m within 10
years (organic / inorganic)
 CH MNC market position #2
 OTC market slowing down to
~8% growth p.a. 2016-20
Brazil
 Market size €2.6bn (#9 OTC market)
 Double-digit CH growth over
past 4 years
 CH MNC market position #6 (up from #10 in
2013)
 OTC market slowing down to
~7% growth p.a. 2016-20
CH execution plans
 Leverage scale to grow more profitably
 Maintain prudent investments to position for
future growth
* Source: Nicholas Hall; MNC: multinational companies
Meet Management in Cologne • September 20, 2016Page 11
Bayer Has a Portfolio of Strong Brands
Source: N. Hall DB6, FY 2015 data
* Includes total “Others” as defined by N. Hall & Co.
Excludes Private Label and Venezuela, MNF: manufacturer
# of OTC
Brands
Avg Sales
Per Brand (€m)
# of CH
Brands by
MNF Sales
MNF Sales
Criteria
10,120
165
92
19
11
< €50m*
€100-250m
€50-€100m
€250-500m
> €500m
7
70
153
361
693
100+
8
8
3
1
Examples
Roche OTC Sagmel Steigerwald
Meet Management in Cologne • September 20, 2016Page 12
Bayer Has the DNA to Successfully Build
Brands
*CAGR (2005-2015) nominal
*CAGR (2013-2015) currency-adjusted vs. Pro Forma
2013*CAGR (2009-2015) currency-adjusted
Total Roche brands growth
2005-2015
 7% CAGR nominal
 +2% pts above market
Total Sagmel brands growth
2009-2015
 21% CAGR (Fx-adj.)
 2x market
Key brand growth 2009-2015
Total Steigerwald brands growth
2013-2015
 19% CAGR c.a.
(vs Pro Forma 2013)
 Fast expansion to Russia
• Strong brand-building efforts with
differentiated marketing tools
• Enhanced distribution coverage
Key brand growth 2013-2015Key brand growth 2005-2015
• Geographic expansion
• Efficiencies with scale &
distribution
• Consistent brand activation
& investment
• Scaled up business in Germany
• International expansion
CAGR*
Aleve 6%
Bepanthen 14%
Berocca 10%
Elevit 16%
Supradyn 2%
Redoxon 8%
CAGR*
Theraflex 17%
Relief 19%
Calcemin 18%
CAGR*
Iberogast 30%
Compelling Consumer Activation Consumer-Centric Innovation
Next generation launch with ClariSpray
“Live Claritin Clear” campaign
1ST Rx brand to broadcast advertise
Rx-to-OTC switch with powerful
visual equity
Alternate forms broaden appeal
Steady introduction of new claims
Antihistamine + decongestant launch
2015 advertising campaign
drives growth worldwide
Meet Management in Cologne • September 20, 2016Page 13
Consistently Growing Allergy Business
Meet Management in Cologne • September 20, 2016Page 14
Expanding Elevit‘s Brand Equity Beyond
Conception and Pregnancy
Conception
and Pregnancy
Male
Fertility
Female
Fertility Breastfeeding
ACROSS THE ENTIRE JOURNEYREASSURANCE
Meet Management in Cologne • September 20, 2016Page 15
Robust Innovation Pipeline Critical
for Long-Term Success
 Tailor development to
needs of different product
categories,
e.g. nutritionals, vs OTCs,
vs personal care
 Build Rx-to-OTC
switches pipeline
 Provide new benefit areas
to consumers
Meet Management in Cologne • September 20, 2016Page 16
Adding Innovation from Diagnosis to Treatment
and Prevention
Bacterial
Vaginosis
Vaginal
Yeast
Infection
Irritation
and
discomfort
Diagnosis
ENABLING WOMEN to confidently manage their intimate health holistically.
Treatment Prevention
Educate and
empower
Confidently choose
the right treatment
Smartly treat with a
triple benefit
Leading & proven
effective innovative
treatments
Soothing and
calming sensation
Protect against
future infections
with probiotics
Meet Management in Cologne • September 20, 2016Page 17
Enhancing Digital Capabilities
Grow mid-term by:
• Driving key market (US,
BRC) growth
• Building category-leading
brands
• Accelerating innovation
• Increasing productivity /
enhancing capabilities
Leverage leadership
position to actively
drive change
in self care industry
Meet Management in Cologne • September 20, 2016Page 18
Summary
BRC: Brazil, Russia, China
Address
current
headwinds
Meet Management Cologne • September 20, 2016Page 19
Proven Track Record of Successful
Portfolio ManagementSummary
Page 19 Meet Management Cologne • September 20, 2016
APPENDIX
Brands Years Old 2015 Sales €m YOY change1
~30 627 +56%
~115 4732 +1%
~20 413 +5%
~70 355 +12%
~40 267 +17%
~110 253 +19%
~80 251 -2%
~60 218 -6%
~70 211 +6%
~30 162 +46%
Top 10 Brands 3,230
Meet Management in Cologne • September 20, 2016Page 20
Sales of Top 10 Brands 2015
1 Fx & portf. adjusted
2 incl. CH Cardio, excl. PH Cardio
Meet Management in Cologne • September 20, 2016Page 21
Consumer Health Division - #1 Player in Highly
Fragmented, Growing OTC Market
in € billion
4.5%
€108.9bn
Bayer Sanofi/BI GroupingGSK J&J Pfizer
RB P&G Takeda Taisho Novartis Other
12%
21%
14%23%
15%
15%
Dermatology
€13.3bn
(+4.0%)
CASF4
€22.8bn
(+7.5%)
Analgesics
€15.5bn
(+5.5%)
Nutritionals
€24.5bn
(+4.2%)
GI3
€16.0bn
(+6.9%)
Others
€108.9bn
(+6%)
Market Positions 20151 Market Category Split 20152
4.4%
4.3%
4.2%
3.5%
2.5%
2.0%
1.1%
1.0%
0.8%
71.7%
Source: Nicholas Hall & Company DB6, FY 2015
1 Market shares include Sanofi/BI Grouping 3 GI: Gastrointestinal
2 Growth 2015 vs 2014 4 CASF: Cold, Allergy, Sinus, Flu
Meet Management in Cologne – September 20, 2016
Liam Condon, Member of the Boad of Management, Head of Crop Science
Investor Presentation – Crop Science
Highly Attractive Agriculture Industry
Benefiting from Macro Trends
(1) Nelson et. al. (2014); (2) FAO 2016 "Climate change and food security“;
(3) This includes Seeds & Traits and Crop Protection
€120
billion
Estimated agriculture inputs
market size by 2025
from ~€85bn in 2015(3)
~10
billion
People on the planet
by 2050
United Nations 2015
-17%
Declining hectares of farmland
per capita by 2050
From 0.218 ha/capita in 2015 to
0.181 ha/capita in 2050(2)
Productivity increase required
to feed the planet by 2050
FAO(2)
+60%
Biophysical effect of climate
change shocks on yields by
2050
Nelson(1) / FAO(2)
-17%
Page 2 Meet Management in Cologne • September 20, 2016
Delivering Enhanced Solutions for Next
Generation of Farming
Page 3
• Overcome increasing gap of demand and availability of skilled labor
• Raise yield given the environmental conditions by taking right
decisions on genetics, agronomic practices and input factors
• Optimize input factors to protect natural resources
• Manage agronomic volatility and better mitigate risks, e.g. weather
and commodity prices
Meet Management in Cologne • September 20, 2016
Increase
Efficiency
Optimize
Yield
Ensure
Sustainability
Manage
Volatility
• Smart combination and optimized
usage of products
• Based on agronomic advice and
digital farming solutions
Integrated Solutions
• Excellence in chemistry and biology
• High-tech breeding capabilities
• Targeted genome optimization
• Computational Life Science
Valuable New Technologies
+
Creating a Global Leader in Agriculture
Based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11); (1) Pro forma figures
without impact of potential disposals; (2) Excludes Adama non-Ag sales;(3) Monsanto calendarized to December 2015
year-end; (4) Bayer 2015 as reported
~45%
~55%
23.1
14.8 14.6
12.7
10.4
5.8
(3)
2015 Pro Forma Sales (in € bn)
(1)
(2)
BASF Ag
Crop Protection Seeds & Traits
Pro forma Pro forma Pro forma
(4)
ChemChina Ag
Syngenta
DuPont Ag
Dow Ag
Page 4 Meet Management in Cologne • September 20, 2016
Targeting Above-Market Growth and Industry
Leading Profitability
Meet Management in Cologne • September 20, 2016Page 5
Combined company expected to deliver above market growth and underlying
EBITDA margin of >30% after year 3 post closing(1)
Broad
Product Portfolio
Truly Global
Footprint
Innovation
Engine
Integrated
Solutions
Substantial Synergy Potential
(1) Not including any potential divestments
Attractive Offering Across All Relevant Product
Segments
Page 6
SeedGrowth
Insecticides
Herbicides
Fungicides
Seeds & Traits
Total
Env. Science
10.4 12.7 23.1
141
10.2
2.9
6.5
1.6
1.1
0.8
2015 Pro Forma Sales (€bn)1
Bayer CS Monsanto
Meet Management in Cologne • September 20, 2016
1based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11);
Pro forma figures without impact of potential disposals; Monsanto calendarized to
December 2015 year-end; Bayer 2015 as reported
A Truly Global Footprint of the Combined
Business
Page 7
Asia Pacific
Latin America
Europe
North America 10.5
5.8
4.7
2.1
1based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11)
Pro forma figures without impact of potential disposals; Monsanto calendarized to December
2015 year-end; Bayer 2015 as reported; rounding errors may cause little differences
Bayer CS
+ Monsanto Industry
45% 24%
25% 26%
20% 23%
9% 27%
2015 Sales Split
Meet Management in Cologne • September 20, 2016
Total 10.4 12.7 23.1
2015 Pro Forma Sales (€bn)1
Bayer CS Monsanto
Successful Integrated Solutions Need
Best-in-Class Technology Offerings
Seeds & Traits
• Superior germplasm
• Strong genetics and breeding
capabilities
Crop Protection incl. Biologics
• Innovative chemistry for weed,
pest and disease control
• Strong Biologics portfolio
Digital Farming
• Extensive data collection and
computation
• Predictive analytics
Integrated
Solutions
Page 8 Meet Management in Cologne • September 20, 2016
• Improved yield
• Optimized inputs
• Sustainable farming
• More convenience
• Improved sourcing
Advancing from Combined Offering
to Integrated Solutions
• Smart combination
and optimized usage
of products
• Based on agronomic advice
and Digital Farming
• Innovation of
integrated systems
based on technologies
optimally designed to
work together
• Ability to offer a broad
variety of seed and
chemical products
• Combining sales
forces and
infrastructure across
geographies
Combined Offering Integrated Solutions
Benefit to the Farmer
From short-term to long-term
Page 9 Meet Management in Cologne • September 20, 2016
Combined Offering to Fully Address
Farmers’ Needs
Seeds
Seed
Treatment
Weed
Management
Pest
Management
Disease
Management
Soybean
plants
with
higher
yield
potential
+
Advanced and comprehensive technology input leveraged with season-long advice
+
(1) Pro forma combined portfolio
The Soybean Brazil Example(1)
Page 10 Meet Management in Cologne • September 20, 2016
Combined Technologies Enable Integrated
Solutions - Corn and Soy Example
(1) Seeds, traits and crop protection, Bayer internal estimates; (2) Source: IHS Global, 05-2016
(3) Source: Phillips McDougall 07-2016; (4) Pro forma; (5) Chemical and biological
• Broad-acre crops corn and soy account for ~40% of global ag market value(1)
• Key growing regions are North/Latin America (~40% of corn and ~80% of soy
global planted acres)(2), thereof > 85% of corn and soy acres is biotech seed(3)
MonsantoBayer Bayer & Monsanto
Combined Portfolio(4)
CROP PROTECTION(5)BIOTECH TRAITS
Pest
Control
Weed
Control
Yield &
Stress
Corn
Soybean
Pest
Control
Yield &
Stress
DIGITAL
FARMING
Disease
Control
SEEDS
Weed
Control
Combined company with strong positions across all technologies offers
high value capturing opportunity in corn and soy in key growing regions
Market
Page 11 Meet Management in Cologne • September 20, 2016
40+ Major Decisions to be Taken
Through Each Planting Season
Agronomic Decision Engine Captures
and Analyzes Data…
… And Makes
Recommendations for Each
Step of the Way
Which seed variety
to plant?
What is the appropriate
level of nutrients?
When and how
to optimize harvest?
Historical Crop
Yield Data
"On-the-Ground"
Sensors
Satellite and
UAV Monitoring
Weather Data Soil Databases
Data Capture and Analysis
Digital Farming helps to improve on-farm decision-making and execution along the
entire planting cycle, helping to maximize yields and improve sustainability
Deliver timely hyper-local and
field-specific information for
 selecting the right varieties
and seeding rate
 plant growth protection
measures
 recognizing plant stress
factors at an early stage
Digital Farming Provides Data-Based Insights
to Optimize Field Specific Decision-Making
How to protect the plant?
Page 12 Meet Management in Cologne • September 20, 2016
Digital Farming Potential of Combined
Portfolio
Integrated solutions of Seeds & Traits and Crop Protection inputs based on optimized
field-level prescriptions to improve on-site decision making and execution
Combining Advanced Digital Farming Capabilities
• Seeds & Planting scripts creator – improving operations
• Nitrogen Advisor – optimized N-fertilizer use
• Field-level weather information and notification – managing weather risks
• >92 million acres enrolled already today
• Leading pest, weed, disease modelling and analytics – increasing resource efficiency
• Hyper-localized decision support tools – optimizing use of Crop Protection products
Long-term Vision:
Outcome-driven value proposition (e.g., “yield guarantee”, “disease-free acre”)
Page 13 Meet Management in Cologne • September 20, 2016
New types of products
• Resistance-breaking herbicide systems
based on innovative traits and chemistry
• Novel macromolecules selectively targeting
pests (e.g., sprayable RNAi)
Data-based decision support
• Advisory tools for on-farm decisions
(e.g., choice of germplasm/seeds)
• Crop Protection applications at ultra-high
precision (e.g., down to single-plant level)
Better / safer products
• Beneficials-friendly products based on in-
depth understanding of physiology
Building Integrated Systems from
Interdisciplinary Approaches
Data
Sciences
& Engineering
Ag equipment and data
processing/evaluation
• Robotics &
Drones
• Sensor
Technology
• Satellite
Technology
• Big Data AnalyticsBiological
Sciences
Chemical
Sciences
Data
Sciences
&
Engineering
New
Integrated
Systems
Potential for faster and more efficient development of customized solutions for farmers
Page 14 Meet Management in Cologne • September 20, 2016
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout
Bayer AG Meet Management 2016 Investor Handout

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Bayer AG Meet Management 2016 Investor Handout

  • 1. Meet Management in Cologne – September 20, 2016 Werner Baumann, CEO of Bayer AG Investor Presentation - Group
  • 2. Certain statements contained in this communication may constitute “forward-looking statements.” Actual results could differ materially from those projected or forecast in the forward-looking statements. The factors that could cause actual results to differ materially include the following: the risk that Monsanto Company’s (“Monsanto”) stockholders do not approve the transaction; uncertainties as to the timing of the transaction; the possibility that the parties may be unable to achieve expected synergies and operating efficiencies in the merger within the expected timeframes or at all and to successfully integrate Monsanto’s operations into those of Bayer Aktiengesellschaft (“Bayer”); such integration may be more difficult, time- consuming or costly than expected; revenues following the transaction may be lower than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) may be greater than expected following the transaction; the retention of certain key employees at Monsanto; risks associated with the disruption of management’s attention from ongoing business operations due to the transaction; the conditions to the completion of the transaction may not be satisfied, or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; the parties’ ability to meet expectations regarding the timing, completion and accounting and tax treatments of the merger; the impact of indebtedness incurred by Bayer in connection with the transaction and the potential impact on the rating of indebtedness of Bayer; the effects of the business combination of Bayer and Monsanto, including the combined company’s future financial condition, operating results, strategy and plans; other factors detailed in Monsanto’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) for the fiscal year ended August 31, 2015 and Monsanto’s other filings with the SEC, which are available at http://www.sec.gov and on Monsanto’s website at www.monsanto.com; and other factors discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. Bayer assumes no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Cautionary Statements Regarding Forward- Looking Information Meet Management in Cologne • September 20, 2016
  • 3. This communication relates to the proposed merger transaction involving Monsanto and Bayer. In connection with the proposed merger, Monsanto and Bayer intend to file relevant materials with the SEC, including Monsanto’s proxy statement on Schedule 14A (the “Proxy Statement”). This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, and is not a substitute for the Proxy Statement or any other document that Monsanto may file with the SEC or send to its stockholders in connection with the proposed merger. STOCKHOLDERS OF MONSANTO ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE PROXY STATEMENT, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain the documents (when available) free of charge at the SEC’s web site, http://www.sec.gov, and Monsanto’s website, www.monsanto.com, and Monsanto stockholders will receive information at an appropriate time on how to obtain transaction- related documents for free from Monsanto. In addition, the documents (when available) may be obtained free of charge by directing a request to Corporate Secretary, Monsanto Company, 800 North Lindbergh Boulevard, St. Louis, Missouri 63167, or by calling (314) 694-8148. Monsanto, Bayer and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the holders of Monsanto common stock in respect of the proposed transaction. Information about the directors and executive officers of Monsanto is set forth in the proxy statement for Monsanto’s 2016 annual meeting of stockholders, which was filed with the SEC on December 10, 2015, and in Monsanto’s Annual Report on Form 10-K for the fiscal year ended August 31, 2015, which was filed with the SEC on October 29, 2015. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the Proxy Statement and other relevant materials to be filed with the SEC in respect of the proposed transaction when they become available. Additional Information and Where to Find It Meet Management in Cologne • September 20, 2016
  • 4. Meet Management in Cologne • September 20, 2016Page 4 Building Leading Life Science Businesses to Create Value Division Leadership Position Leading position in cardiology, hematology, radiology, women’s health Global #1 OTC business with strong portfolio of leading brands After the acquisition of Monsanto, a global leader in seeds, traits, crop protection and digital farming; #5 globally in Animal Health Pharmaceuticals Consumer Health Crop Science / Animal Health Acquisition of Monsanto pending
  • 5. Page 5 Monsanto Acquisition - Transformative Step to Strengthen Life Science Portfolio 2015 Pro Forma Life Science Sales Health care businesses 49% Crop Science Total €47.1bn Monsanto 49% combined pro forma Excluding Covestro Monsanto sales calculated at avg. 2015 Fx rate (USD/EUR=1.11) Industry Leadership • Creating a global leader in agriculture with an integrated agricultural offering • Broad product portfolio and R&D pipeline to deliver enhanced solutions for farmers Significant Value Creation • Substantial synergy potential • Accretion to core EPS in the first full year • Potential for premium valuation of combined agriculture business Consistent with Bayer’s Strategy • Agriculture market driven by innovation • Attractive long-term growth market • Building of leadership position Meet Management in Cologne • September 20, 2016 Acquisition of Monsanto pending
  • 6. Key Metrics of the Monsanto Transaction Page 6 Meet Management in Cologne • September 20, 2016 Acquisition of Monsanto pending Offer Summary • All-cash consideration of $128 per Monsanto share • Enterprise value (EV) of $66bn including net debt • Transaction unanimously approved by Monsanto’s Board of Directors, Bayer’s Board of Management and Bayer’s Supervisory Board Key Metrics • Premium of 44% to Monsanto’s undisturbed share price of $89.03(1) • Premium of 43% to Monsanto’s three-month volume weighted average share price(1) • LTM(2) EBITDA multiple of 18.6x as of May 31, 2016; consensus(3) FY 2017 EBITDA multiple of 16.5x (1) As of May 9, 2016, the day before Bayer’s first written proposal to Monsanto; (2) Last Twelve Months (3) as per Bloomberg, Sep 13, 2016; Fx rate: USD/EUR=1.11
  • 7. Key Metrics of the Monsanto Transaction (cont´d) Page 7 Meet Management in Cologne • September 20, 2016 Acquisition of Monsanto pending Value Creation • Significant value creation through expected synergies confirmed in due diligence: • ~$1.5bn annual net synergies after year three (~80% cost, ~20% sales) • Additional synergies from integrated solutions increasing over the years thereafter • Transaction expected to be accretive to core EPS in the first full year after closing; double-digit percentage core EPS accretion expected in the third full year after closing • Expect to earn cost of capital after year 4 post closing Financing • Permanent financing expected to consist of a combination of debt and equity • Expected equity component of ~$19bn, expected to be raised through issuance of mandatory convertible bonds and through a rights issue with subscription rights
  • 8. Path to Completion of the Monsanto Transaction Page 8 Acquisition of Monsanto pending Meet Management in Cologne • September 20, 2016 • September 14, 2016: Signing of merger agreement between Bayer and Monsanto • September, 2016: Commence discussions with regulatory agencies • Late 2016/ early 2017: Monsanto to convene shareholder meeting to vote on merger agreement • Closing expected by the end of 2017
  • 9. Meet Management in Cologne • September 20, 2016Page 9 Proven Track Record of Successful Portfolio Management Lanxess Schering Diagnostics H.C. Starck Wolff Walsrode Dihon Algeta Merck OTC Covestro (partial IPO) Diabetes Care Roche OTC Conceptus Steigerwald Interventional Number of closed transactions Total transaction value Signing of merger agreement with Monsanto Transforming into a Life Science company – total transaction value of ~€52bn in ~130 closed deals since 2005 AgraQuest Stoneville Cotton Seed Athenix Rebuilding Pharma Strengthening HealthCare and CropScience Transforming into a Life Science company 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Acquisition of Monsanto pending
  • 10. Meet Management in Cologne • September 20, 2016Page 10 Clear Portfolio Management Criteria Drive Value Generation • Focus on markets with long-term GDP+ growth potential • Ability to generate attractive returns • Success driven by innovation-based business models • Potential to achieve leadership positions • Bayer as the best owner General Portfolio Criteria • Decisions based on regular portfolio review and market opportunity • Strong DCF-based value creation imperative • Key performance indicators including sales growth relative to market, core EPS accretion and value generation • No capital allocation to one business at the cost of underinvestment in another business • Proven integration/ separation capabilities Portfolio Management Approach
  • 11. 1 2015 figures restated, Crop Science as reported; 2 2015 pro forma combined EBITDA margin; Monsanto calendarized to December 2015 year-end; 3 From December 31, 2004 through September 13, 2016 Proven Integration Track Record Building Leading Life Science Franchise Meet Management in Cologne • September 20, 2016Page 11 Delivering Shareholder Value Through Strong Execution 3.2 15.3 2004 2015 1.3 6.1 2004 2015 5.9 10.4 12.7 2004 2015 Rebuilt Pharma Global Leadership in Consumer Health 23.1 Monsanto Building a New Leader in Crop Science • Experienced acquirer having successfully integrated various multi-billion € transactions • Aventis CropScience • Schering • Roche OTC • Merck & Co. Consumer Care • Monsanto integration no more complex than previous large integrations + 20 Sales and EBITDA Margin1 2130 24 21 ~272 Sales, €bn EBITDA Margin, % Increased market cap ~4x since 20043
  • 12. Meet Management in Cologne • September 20, 2016Page 12 Consistent Track Record of Strong Operating Performance Continued businesses for 2014/2015; 2015 figures restated Adj. EBITDA: EBITDA before special items 35.1 36.5 39.7 40.2 41.3 46.1 7.1 7.6 8.3 8.4 8.7 10.3 2010 2011 2012 2013 2014 2015 4.83 5.30 5.61 5.89 6.824.19 20.2 20.8 20.8 20.9 21.0 22.3 CAGR 2010-2015 Sales +6% Adj. EBITDA +8% Core EPS +10% Sales (€bn) Adj. EBITDA (€bn) Adj. EBITDA margin (%) Core EPS (€)
  • 13. Meet Management in Cologne • September 20, 2016Page 13 H1 2016 – Successful Operating Performance and Strategic Progress 2015 figures restated Sales €m, % FX & portf. adj. EBIT €m +3% 23,68723,769 H1’16H1’15 +19% 4,458 3,748 H1’16H1’15 EBITDA before special items, €m Core EPS cont. operations, € +11% 6,441 5,810 H1’16H1’15 +9% 4.42 4.05 H1’16H1’15  New approvals for Kovaltry and Xofigo  Patent term for Rivaroxaban extended in USA  Positive phase III data for Regorafenib in unresectable liver cancer  Stake in Covestro reduced to 64%  All-cash offer to acquire Monsanto published  Agreement signed to sell the Consumer business of Environmental Science  Closing of Diabetes Care divestment  Outlook for 2016 raised Highlights H1 2016
  • 14. Meet Management in Cologne • September 20, 2016Page 14 FY 2016 – Group Outlook Raised 2015 figures restated Assuming end Q2 2016 Fx rates (USD 1.11) Outlook depends on specific planning assumptions as detailed in the Annual Report Sales ∆ % yoy Fx and portfolio adj., EBITDA before special items; Continuing operations 2015 2016 update July Sales Group €46.1bn Low-single-digit % increase to €46–47bn Life Sciences €34.1bn Mid-single-digit % increase to ~€35bn Adj. EBITDA Group €10.3bn High-single-digit % increase Life Sciences €8.6bn Mid- to high-single-digit % increase Core EPS €6.82 Mid- to high-single-digit % increase
  • 15. Meet Management in Cologne • September 20, 2016Page 15 Mid-Term Aspirations Emphasize Attractive Growth and Margin Potential Sales ∆ Fx & portf. adjusted, EBITDA before special items, continuing operations Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016 Sales Growth CAGR 2015-2018 Adjusted EBITDA Margin 2018 Pharma ~6% 32-34% Despite dilution through Radiology and significant R&D investment Consumer Health 4-5% ~25% Animal Health 4-5% 23-24% Crop Science (incl. Monsanto)* Above market growth >30% after year 3 post closing Acquisition of Monsanto pending * Not including any potential divestments
  • 16. Aspiration 2018 Meet Management in Cologne • September 20, 2016Page 16 Increased Underlying Pharma Margin Expectations for 2018 Pharma EBITDA margin before special items 1) RAD: Radiology business became part of Pharma effective Jan. 1, 2016 2) Current planning for 2018 compared to planning in 2015 As of March 2015 As of September 2016 32–34% Depending on level of R&D investment 32–34% Depending on level of R&D investment Aspiration 2017 Margin Dilution by RAD1 Higher R&D Investment2 Per- formance -0.8% pts -0.6% pts Fx +0.3% pts +1.1% pts
  • 17. Meet Management in Cologne • September 20, 2016Page 17 Focused Leadership Strategy at Pharma to Deliver Growth and to Create Value • Deliver on mid-term growth and margin aspirations • Balance margin expansion and need to invest in securing long- term growth • Build pipeline organically and pursue in-licensing and bolt-on M&A options • Focus research on Cardiovascular and Oncology • Foster late-stage development to fully develop high value projects • Support leading positions in Hemophilia, Women’s Health and Ophthalmology • Focus on key therapeutic areas and build / main- tain leading positions • Cardiovascular • Hemophilia • Women’s Health • Oncology • Continue to maximize growth potential of Xarelto, Eylea, Xofigo, Stivarga, Adempas Deliver Growth Drive Innovation Create Value
  • 18. Xarelto Stivarga Eylea Adempas Xofigo Rec. Launched Products Meet Management in Cologne • September 20, 2016Page 18 Combined Peak Sales Potential of Recently Launched Products Increased to > €10bn * PSP: peak sales potential > €5bn ~ €3.5bn New PSP*Old PSP > €2.5bn ≥ €1.5bn New PSP*Old PSP > €1bn≥ €1bn New PSP*Old PSP ≥ €1bn≥ €1bn New PSP*Old PSP > €0.5bn≥ €0.5bn New PSP*Old PSP > €10bn ≥ €7.5bn New PSP*Old PSP
  • 19. Meet Management in Cologne • September 20, 2016Page 19 Consumer Health to Maintain Global OTC Leadership and to Improve Profitability • Accelerate consumer- centric innovation • Create more effective innovation processes • Exploit growth potential of Rx/OTC switches • Build new digital capabilities • Deliver growth in key markets including USA, China, Brazil, Russia • Refocus investments to mature markets which are regaining momentum • Continue prudent investments in emerging markets • Leverage scale to grow more profitably • Focus on category- leading, global brands • Execute brand strategies in a differentiated, country-specific approach, tailored to local market requirements Build Global Brands Drive Key Market Growth Accelerate Innovation
  • 20. Meet Management in Cologne • September 20, 2016Page 20 Broad Portfolio of Consumer Health Brands with Sales of > €100 million p.a. Each Sales FY 2015 * including Rx Aspirin Cardio ** Alka Seltzer family €997 million* €627 million €413 million €355 million €128 million €111 million €110 million €267 million €253 million €251 million** €218 million €211 million €162 million €159 million €158 million
  • 21. Meet Management in Cologne • September 20, 2016Page 21 Key Takeaways Two Years After the Acquisition of Merck & Co’s Consumer Care Business • Key brands (e.g. Coppertone & Dr. Scholl´s) were underinvested • Weak product pipeline (low visibility during bidding process) • Product discontinuation (Oxytrol) • Underestimated country risk from Emerging Markets volatility • Stronger business disruption than anticipated during integration of Merck Consumer Care & Dihon in China Focus on delivering the full potential of Merck & Co. Consumer Care by • Increased investment in key brands • Rebuilding Coppertone and Dr. Scholl´s • Driving growth in the USA supported by significant new product introductions
  • 22. Meet Management in Cologne • September 20, 2016Page 22 Combined Crop Science Company Well Positioned to Deliver Superior Performance • Realize full synergy potential of the combined businesses • Deliver above market growth and superior margins • Advance strong pipeline across crops, indications and technologies • Deploy joint innovation capabilities to deliver enhanced solutions for the next generation of farming • Deliver integrated systems based on technologies optimally designed to work together • Create integrated agriculture offerings • Fully leverage combinations and optimized usage of products based on agronomic advice and digital farming • Enable integrated solutions for broad-acre crops corn and soy Integrated Solutions Lead Innovation Deliver Value Proposition Acquisition of Monsanto pending
  • 23. Meet Management in Cologne • September 20, 2016Page 23 Significant Strategic Benefits Due to Strong Position Along Key Criteria A leading player with significant revenue base and high R&D spendScale Broad product portfolio across indications and cropsBreadth Best-in-class combination of science, innovation history and R&D effort globally R&D Combination of the high-quality seeds & traits and crop protection pipelines across key crops Pipeline Ability to provide farmers with integrated solutions immediately and into the future Integrated Solutions Opportunity to create a global leader by combining strengths of both organizations in digital farming Digital Farming Acquisition of Monsanto pending
  • 24. Meet Management in Cologne • September 20, 2016Page 24 Confidence in Our R&D Investments R&D 2016e: ~€4.5bn • 55 projects in clinical development at Pharma • 30 successful phase III clinical trials at Pharma since 2010 • Strengthened brands through multiple line or product introductions at Consumer Health • Launched 12 active ingredients between 2006 and 2016 at Crop Science • New product introductions at Animal Health (Seresto, Zelnate / Victrio) Achievements Covestro Pharma Animal Health 58% 25% 6% Crop Science 6% Recon. 2% Consumer Health 3%
  • 25. Meet Management in Cologne • September 20, 2016Page 25 Increased R&D Spending at Pharma - Significant Investment in Life Cycle Management 2015 R&D Investment at Pharma Research ~20% ~45% Life Cycle Management 1.8 1.7 1.7 1.8 2.0 2.4 2010 2011 2012 2013 2014 2015 15.8 14.6 13.5 13.9 14.7 15.7 R&D as % of sales Development €2,402m ~35% € billion; Pharma including Radiology
  • 26. Meet Management in Cologne • September 20, 2016Page 26 Key Pharma Pipeline Assets With Combined Peak Sales Potential of  €6 billion Pipeline Project Indication Peak Sales Potential Vericiguat1 Worsening chronic heart failure ~ €0.5bn Finerenone Diabetic kidney disease ≥ €1.0bn Vilaprisan Uterine fibroids ≥ €1.0bn BAY-1841788 (ODM-201) Non-metastatic castration-resistant prostate cancer Metastatic hormone-sensitive prostate cancer ≥ €1.0bn Anetumab Various cancers2 ≥ €2.0bn Copanlisib Lymphoma ≥ €0.5bn 1) In cooperation with Merck & Co. 2) Ovarian, Mesothelioma, etc.
  • 27. Stivarga HCC 2L Visanne Endo Amikacin inhale Damoctocog alpha Tedizolide ODM-201 nmCRPC Anetumab Cancer Xofigo combo Xarelto LCM • MACE • ESUS • CHF • Med. ill Finerenone DKD Xarelto LCM PAD Vilaprisan UF Vericiguat WCHF Xofigo Breast Riociguat Syst. Sclerosis Anetumab Cancer ODM-201 mHSPC Meet Management in Cologne • September 20, 2016Page 27 New Product and Life Cycle Management Launches Planned at Pharma First expected launches in first countries; Eylea Life Cycle Management not included Selection of projects, regional and small projects not shown; Launches subject to successful clinical development and regulatory approval 2017 2018 2019 2020 2021 2022 2023 Xarelto LCM ACS dual Copanlisib Lymphoma
  • 28. 24-hour nasal glucocorticoid formulated to relieve nasal allergy symptoms Analgesic for relief of occasional sleeplessness when associated with minor aches and pains New formulation of Aspirin that works twice as fast as previous Aspirin tablets Specialist suncare leveraging Bepanthen’s strong derma- tology equity and Bayer’s health credentials Food supplement rich in vitamins and minerals formulated as orodispersable tablet Meet Management in Cologne • September 20, 2016Page 28 Robust Consumer-Centric Innovation at Consumer Health Examples only ClariSpray Aleve PM Micro Active Aspirin Bepanthen Sun Berocca On-the-Go
  • 29. Meet Management in Cologne • September 20, 2016Page 29 Creation of a Leading Innovator 2.5 1.6 1.3 0.7 Bayer CS + Monsanto Dow Ag + DuPont Ag Syngenta + ChemChina Ag BASF Ag 11.410.6 10.6 8.5% of Sales • > 40 major R&D sites worldwide • > 200 breeding stations in all relevant geographies • ~10,000 employees in R&D • Strong R&D technology platform • Cross-technology capabilities • > 70 pipeline advancements over last two years 2015 Pro Forma R&D Investment (€bn)1 Seeds & TraitsCrop Protection Total 3 Strong pipeline across crops, indications and technologies Combined Strength in Innovation2 1 Based on company information and internal calculations excl. synergies (at avg. 2015 Fx rate USD/EUR=1.11) 2 Pro forma; 3 BASF: includes ~€150 million for Plant Science
  • 30. Meet Management in Cologne • September 20, 2016Page 30 Bayer – A World-Class Life Science Company LCM: Life Cycle Management; LoE: Loss of exclusivity; PSP: Peak sales potential Acquisition of Monsanto pending Value- Creating Portfolio Management Continuous Prosperous Performance Excellence in Innovation to Foster Future Growth • Creating a global leader in agriculture through acquisition of Monsanto • Proven integration/separation capabilities • Track record of delivering shareholder value through successful portfolio management • Upcoming new product launches and LCM at Pharma expected to mitigate LoE post 2023 • Combined PSP of key late-stage Pharma pipeline assets €6bn • Consumer Health delivering steady stream of consumer-centric innovations • Strong R&D capabilities at combined Crop Science business • Mid-term aspirations emphasize growth and margin potential • Pharma launch products expected to drive growth; PSP increased to >€10bn • Consumer health challenges addressed • Crop Science expected to benefit from cyclical market upswing and long-term GDP+ growth potential
  • 31. Meet Management in Cologne – September 20, 2016 Dieter Weinand, Member of the Board of Management, Head of Pharmaceuticals Investor Presentation – Pharma
  • 32. Meet Management in Cologne • September 20, 2016Page 2 Fast-Growing Pharma Business 10.0 9.9 10.8 11.2 12.1 15.3 2010 2011 2012 2013 2014 2015 1H'16 € billion; ∆% yoy Fx & portfolio adj. Sales Leading novel oral anti-coagulant Successful launch of 5 products Success in treatment of retinal diseases First-in-class -pharmaceutical First marketed sGC modulating agent Multi-kinase inhibitor for cancer treatment 8.0 2015 figures restated +10% +1% +4% +9% +11% +9%
  • 33. Meet Management in Cologne • September 20, 2016Page 3 FY 2016 Guidance Increased 2015 2016 (update July) Sales €15.3bn High-single-digit % increase to >€16bn Sales of Recently Launched Products €4.2bn Toward €5.5bn EBITDA before special items €4.6bn Low-teens % increase Adj. EBITDA margin 30.1% Improve Assuming end Q2 2016 Fx rates (USD 1.11); Outlook depends on specific planning assumptions as detailed in the Annual Report; 2015 figures restated Sales ∆ Fx & portf. adjusted, adj. EBITDA margin = EBITDA before special items to sales
  • 34. Meet Management in Cologne • September 20, 2016Page 4 Mid-Term Aspirations 2018 2015 Aspiration 2018 Sales +9.1% to €15.3bn ~6% CAGR (2015-2018) Adj. EBITDA margin 30.1% 32 - 34% despite dilution through RAD and significant investment in R&D 2015 figures restated; RAD: radiology business – became part of Pharma effective January 1, 2016 Sales ∆ Fx & portf. adjusted, EBITDA before special items Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
  • 35. Meet Management in Cologne • September 20, 2016Page 5 Combined Peak Sales Potential of Recently Launched Products Raised to >€10bn Combined peak sales potential for Xarelto, Stivarga, Eylea, Xofigo and Adempas assuming approvals and launches as planned; LCM: life cycle management; CRC: colorectal cancer; HCC: hepatocellular cancer; PH: pulmonary hypertension Old ~€3.5bn ≥€1.5bn ≥€1bn ≥€1bn ≥€0.5bn Current >€5bn >€2.5bn >€1bn ≥€1bn >€0.5bn • Continued successful performance and LCM • Continued successful performance • Broadened LCM activities • Positive phase III in 2nd line HCC • Phase III in adjuvant CRC initiated • Multiple LCM activities including non-PH indications • Continued successful performance
  • 36. Meet Management in Cologne • September 20, 2016Page 6 Fully Realize Pipeline Potential * Combined peak sales potential for assets as above assuming approvals and launches as planned; nmCRPC: non-metastatic castration resistant prostate cancer; mHSPC: metastatic hormone-sensitive PC; WCHF: worsening chronic heart failure Anetumab- Ravtansine ODM-201 Finerenone Vilaprisan Vericiguat 2019 2019 2020 2021 2021 ≥€2bn ≥€1bn ≥€1bn ≥€1bn ~€0.5bn Various cancer types nmCRPC mHSPC Diabetic kidney disease Uterine fibroids WCHF Copanlisib 2018 ≥€0.5bn Lymphoma Combined* Peak Sales Potential ≥€6bn first expected launches in first countries
  • 37. Meet Management in Cologne • September 20, 2016Page 7 Focused Leadership Strategy for Pharma Build on leading positions in • Cardiology / Thrombosis • Woman’s HealthCare • Hemophilia Establish focused segment leadership positions in Oncology • Realize blockbuster potential for marketed drugs Xofigo and Stivarga • Focus and reinforce Oncology R&D Fully realize pipeline potential
  • 38. Meet Management in Cologne • September 20, 2016Page 8 Leading Cardiovascular Portfolio LCM: life cycle management; HFrEF: heart failure with reduced ejection fraction; HFpEF: HF with preserved EF; PoC: proof of concept; DKD: diabetic kidney disease; CV: cardiovascular Thrombosis Heart Failure Kidney Mature Brands • Fully support Finerenone in DKD to build a leadership position in nephrology • Pursue out-licensing options for Molidustat • Advance early pipeline projects to establish franchise • Continue Ph3 preparation of Vericiguat (HFrEF) in collaboration with Merck & Co. Inc. • Pursue development of Neladenoson (Partial A1agonist) in HFrEF and HFpEF in parallel • Continue to advance chymase inhibitor and dual vasopressin receptor antagonist to PoC • Xarelto performance excellent – peak sales estimate raised to >€5bn • Continue to invest in Xarelto LCM and launch preparations of LCM indications • Pursue FXI/FXIa inhibition approach • Adalat – a cornerstone in CV disease treatment • Glucobay – continued growth expected in Emerging Markets, especially China • Aspirin Cardio – continued growth expected
  • 39. Meet Management in Cologne • September 20, 2016Page 9 Xarelto – Peak Sales Potential Estimates Raised - Again € billion Peak Sales Estimates 2007 2014 2016 • Continued excellent performance – Xarelto now a TOP 15 global Pharma brand1 • >21 million patients treated since launch2 • Further growth potential driven by: • Under-served patient populations in launched indications • Demographics • Shift from warfarin • New indications targeting patients currently not treated with anticoagulants 1: according to IMS; 2: calculation based on IMS Health MIDAS database >2.0 ~3.5 >5.0
  • 40. Meet Management in Cologne • September 20, 2016Page 10 Xarelto Life Cycle Management Program Addressing The Full Range of Unmet Need Stroke Prevention Arterial Thromboembolism Venous Thromboembolism CAD: coronary artery disease; PAD: peripheral artery disease; VTE: venous thromboembolism • Patients with Atrial Fibrillation • Patients without Atrial Fibrillation • Patients with acute CAD/PAD • Patients with chronic CAD/PAD • Patients with venous thromboembolism • Patients in need for VTE prevention
  • 41. Meet Management in Cologne • September 20, 2016Page 11 Finerenone – Opportunity to Lead in Diabetic Kidney Disease DKD: diabetic kidney disease; CKD chronic kidney disease; MRA: mineralocorticoid receptor antagonist • Finerenone is a novel non-steroidal MRA with a differentiated profile • Steroidal MR antagonists are not approved for kidney diseases • A Finerenone phase IIb (ARTS-DN) study in Diabetic Nephropathy was successfully completed Finerenone  Significant need for innovative therapies  Phase III program in DKD progressing as planned • Market for chronic kidney disease estimated at ~$14bn in 2024 • Resulting complications from Diabetes accounting for 35% of CKD • ~40% of new cases of end-stage renal disease (ESRD) are due to Diabetes Mellitus (DM) • Patients with Type II DM and CKD are at high risk of cardiovascular (CV) death Diabetic Kidney Disease
  • 42. Meet Management in Cologne • September 20, 2016Page 12 Vericiguat – Potential First-in-Class Treatment for Chronic Heart Failure • A lack of sGC stimulation leads to the reduced activity of the “nitric oxide- sGC-cGMP” pathway, causing coronary dysfunction and progressive myocardial damage • By directly stimulating the critical enzyme sGC, Vericiguat restores this pathway and in turn may improve heart and vascular function • Phase III (VICTORIA) trial assesses a potential reduction in mortality and morbidity on top of standard of care in HFrEF patients • VICTORIA trial initiated1 1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic heart failure; HFrEF: heart failure with reduced ejection fraction Novel approach targeting the critical cGMP cardiovascular pathway that is impaired in CHF patients
  • 43. Meet Management in Cologne • September 20, 2016Page 13 Establish Focused Leadership Positions in Oncology nmCRPC: non-metastatic castration resistant prostate cancer; LCM: life cycle management; ADC: antibody-drug conjugate; iNHL: indolent Non- Hodgkin’s lymphoma Xofigo • Target “agent of choice” status - clear survival benefit for patients with bone metastases in prostate cancer demonstrated • Expand in additional cancer types beyond prostate cancer Stivarga Nexavar Focus Oncology R&D Execute launch pipeline • Build position in hepatocellular carcinoma (HCC) • Strengthen position in colorectal cancer through LCM in adjuvant setting • Reinforce leadership in liver cancer through capitalizing on optimal treatment continuum / sequence for Nexavar & Stivarga in HCC • Differentiation for leadership in selected areas (Thorium platform; ADC’s) • Focus on differentiated programs • Stivarga HCC 2L  launch 2017e • Copanlisib iNHL  launch 2018e • Anetumab R. mesothelioma  launch 2019e • Xofigo additional indications/uses  first launch 2019e • ODM-201 in nmCRPC  launch 2019e
  • 44. Meet Management in Cologne • September 20, 2016Page 14 Expanding Xofigo’s Position in Castration- Resistant Prostate Cancer Treatment For details on approved indications see respective product labels; Zytiga® is a trademark of Johnson & Johnson Metastatic castration-resistant prostate cancer Asymptomatic bone metastases Potential new disease area for combination therapy Symptomatic bone metastases Xofigo (radium Ra 223 dichloride injection) Novel antihormonal agents (eg. Zytiga® [abiraterone]) Chemotherapy • Combination therapy with abiraterone, an inhibitor of testosterone synthesis • Expansion to earlier disease stages enhances accessible patient population • A delay of skeletal-related events is of major clinical importance
  • 45. • ODM-201 is a potent and full AR antagonist • Promising efficacy profile demonstrated in previous studies • Inhibits growth of prostate cancers in preclinical studies • Significantly decreases PSA levels in patients with progressive CRPC • Sustained PSA reduction was observed at higher dose levels • ODM-201 antagonizes mutant ARs linked to resistance to other AR antagonists (ie, bicalutamide, enzalutamide) • Phase III program ongoing addressing i. hormone sensitive metastatic prostate cancer ii. non-metastatic CRPC Meet Management in Cologne • September 20, 2016Page 15 ODM-201 – A Novel, New-Generation Nonsteroidal AR Antagonist AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen
  • 46. Meet Management in Cologne • September 20, 2016Page 16 R&D Differentiates Through Targeted Alpha- Pharmaceuticals and Novel Toxophor ADCs • Thorium-platform unique to Bayer • Thorium-platform offers to deliver alpha emitters to every tumor • Thorium-platform offers synergies with Xofigo with respect to manufacturing and supply chain • Advanced and broad ADC program established • Synergies between Thorium – and ADC platforms with respect to antigens, antibodies, linker technologies, etc. 223Ra Decay Targeted Thorium Conjugates (TTCs) Antibody Drug Conjugates (ADCs)
  • 47. Meet Management in Cologne • September 20, 2016Page 17 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 • Fast proof of concept targeted – Phase I for -CD22 Th-227 conjugate progressing • Next steps initiated to explore Thorium platform in solid tumors + Th-227 Percentsurvival CB17 SCID Statistical Analysis (Mantel-Cox test) < 0.0001 (****) Animals treated 5 days after inoculation of HL60 (AML) For all surviving animals no tumors were found on dissection Preclinical disseminated AML tumor model AML: acute myeloid leukemia
  • 48. Meet Management in Cologne • September 20, 2016Page 18 Anetumab Ravtansine Program Advancing * Blumenschein et al. ASCO 2016; ADC: antibody drug conjugate Mode of action: • ADC targeting tumor-associated antigen mesothelin, and delivering toxophore DM4, which acts on proliferating cells (tubulin inhibitor) Potential spectrum of indications determined by mesothelin expression pattern: • mesotheliomas (100%) • pancreatic cancer (~80-100%) and • ovarian adenocarcinomas (~80%) Clinical program: • Phase I* with promising results including duration of treatment of > 1,000 days • Registrational phase II in metastatic pleural mesothelioma ongoing
  • 49. Meet Management in Cologne • September 20, 2016Page 19 Summary • Projecting future growth for Pharma • Peak sales estimates for recently launched products increased to > €10bn • Pipeline holds promise with a peak sales potential* of selected assets of ≥ €6bn • Build on existing leading positions in key therapeutic areas • Expand successful cardiovascular business • Focus Oncology portfolio and build leading segment positions * Combined peak sales potential for Copanlisib, Anetumab Ravtansine, Finerenone, Vericiguat, Vilaprisan and ODM-201 assuming approvals and launches as planned
  • 50. Meet Management in Cologne • September 20, 2016Page 20 Proven Track Record of Successful Portfolio ManagementSummary Page 20 Meet Management Cologne • September 20, 2016 APPENDIX
  • 51. Meet Management in Cologne • September 20, 2016Page 21 Proven Track Record of Successful Portfolio ManagementSummary Page 21 Meet Management Cologne • September 20, 2016 Leading Cardiovascular Portfolio
  • 52. • Xarelto continues its outstanding performance in 2016 – became one of the TOP 15 Global Pharma Brands according to IMS • Confident in growth potential – Xarelto’s peak sales potential estimate raised to >€5bn • Comprehensive life cycle management program to support future growth • Beyond, Xarelto, Factor XI pathway is a research focus to potentially lead the next wave of innovation in thrombosis Meet Management in Cologne • September 20, 2016Page 22 Bayer – A Leading Player in Thrombosis
  • 53. Meet Management in Cologne • September 20, 2016Page 23 Xarelto Life Cycle Management Program Addressing The Full Range of Unmet Need Stroke Prevention Arterial Thromboembolism Venous Thromboembolism CAD: coronary artery disease; PAD: peripheral artery disease; VTE: venous thromboembolism • Patients with Atrial Fibrillation • Patients without Atrial Fibrillation • Patients with acute CAD/PAD • Patients with chronic CAD/PAD • Patients with venous thromboembolism • Patients in need for VTE prevention
  • 54. Meet Management in Cologne • September 20, 2016Page 24 Xarelto Life Cycle Management Studies: Addressing Stroke Prevention Study Indication Objective Completion* Secondary stroke prevention in patients with a recent ESUS Evaluate whether Rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS) (N~7,000) Q4’17e SPAF/ ACSsp Safety of two Rivaroxaban regimens vs. VKA after PCI in non-valvular AF patients (N~2,100) Q2’16e Transcatheter aortic valve replacement (TAVR) To assess a Rivaroxaban-based anticoagulation regimen following successful TAVR balancing ischemic and bleeding outcome measures (N~1,500) tbd SPAF Efficacy and safety of Rivaroxaban for prevention of CV events in non-valvular AF patients undergoing cardioversion vs. VKA (N=1,504) Completed and reported SPAF Safety of uninterrupted Rivaroxaban vs VKA in non- valvular AF patients undergoing catheter ablation (N~250) Completed and reported SPAF Efficacy of Rivaroxaban for LA thrombus resolution in non-valvular AF/flutter patients (N~60) Completed and reported SPAF Safety of Rivaroxaban for stroke prevention in non-valvular AF. Region: Europe (N=6,784) Completed and reported * current estimates on primary completion
  • 55. Meet Management in Cologne • September 20, 2016Page 25 Xarelto Life Cycle Management Studies: Addressing Arterial Thromboembolism Study Indication Objective Completion* Coronary artery disease (CAD) / peripheral artery disease (PAD) Efficacy and safety of Rivaroxaban vs. low-dose Rivaroxaban plus ASA or ASA alone in reducing the risk of major cardiac events in patients with CAD or PAD (N~27,000) 1H’18e Heart failure (HF) / coronary artery disease (CAD) Efficacy of Rivaroxaban vs. placebo in patients with significant CAD and HF receiving antiplatelet therapy (N=5,000) 1H’18e Peripheral artery disease (PAD) To assess the potential benefits of Rivaroxaban in reducing major thrombotic vascular events in patients with PAD undergoing peripheral artery interventions (N=6,500) 1H’19e ACSsp Safety of Rivaroxaban vs. ASA in combination with single antiplatelet treatment (Clopidogrel or Ticagrelor) for long-term secondary prevention in patients with recent ACS in a broader range of patients (N=2,000 – 3,000). If successful, this phase II study will be followed by a confirmatory, fully powered global phase III study End 2016e / early 2017e ACSsp Rivaroxaban plus dual antiplatelet therapy vs. UFH during elective PCI (N=107) Completed and reported * current estimates on primary completion; UFH: unfractionated heparin; PCI: percutaneous coronary intervention
  • 56. Meet Management in Cologne • September 20, 2016Page 26 Xarelto Life Cycle Management Studies: Addressing Venous Thromboembolism * current estimates on primary completion Study Indication Objective Completion* Long-term preven- tion of recurrent symptomatic VTE in patients with symp- tomatic DVT and / or PE Efficacy and safety of reduced-dosed Rivaroxaban, standard-dosed Rivaroxaban vs. ASA for preventing VTE in patients with symptomatic DVT and/or PE (N=3,300) End 2016e Rivaroxaban in cancer associated thrombosis Program with oncology-based, complementary studies to address oncologists questions on treatment and prevention of VTE, while building Xarelto treatment pathways into the cancer care environment. A compilation of different studies ongoing Medically ill patients at risk of VTE after hospital discharge Efficacy and safety of Rivaroxaban vs. placebo in reducing post-discharge VTE risk in medically ill patients (N=8,000) 1H’18e VTEx in children Efficacy and safety of Rivaroxaban vs. SOC for treatment and secondary prevention of VTE in the paediatric population. A series of phase I, II, III studies (N=160) 1H’19e VTEp OS Safety and efficacy of Rivaroxaban vs SOC in VTE prophylaxis after major orthopaedic surgery (N=17,701) Completed and reported VTEx Safety of Rivaroxaban vs SOC for acute DVT treatment (N=5,142) Completed and reported
  • 57. Meet Management in Cologne • September 20, 2016Page 27 NAVIGATE ESUS Embolic Stroke of Undetermined Source Study Study title: Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) www.clinicaltrials.gov/ct2/show/NCT02313909 Objective: Efficacy of Rivaroxaban in reducing the risk of recurrent stroke and systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS) Short design: Multicentre, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority study Indication: Secondary stroke prevention in ESUS Start: Q4’2014 Completion: End 2017e 30 days Safety Follow-up Rivaroxaban 15 mg od ASA 100 mg od Efficacy Cut-off Date Study End Event-driven study N~7,000 1:1 Day 1 R Total study duration: ~3 years Mean treatment duration per patient: ~2 years Population: Patients with recent embolic stroke of undetermined source
  • 58. Meet Management in Cologne • September 20, 2016Page 28 NAVIGATE ESUS Study Details # including but not limited to; ‡ any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labelling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/ct2/show/NCT02313909 • Composite of Stroke (ischemic, hemorrhagic, and undefined stroke, transient ischemic attack with positive neuroimaging) and Systemic embolism Primary efficacy endpoint • Patients with recent ischemic stroke and • Stroke not being lacunar • No cervical carotid atherosclerosis • No AF • No intracardiac thrombus • No other specific cause of stroke Key inclusion criteria# • ISTH major bleeding Primary safety endpoint • Severe disabling stroke (modified Rankin score ≥4 at screening) • CrCl <30 ml/min • Indication for chronic anticoagulation or antiplatelet therapy Key exclusion criteria‡
  • 59. Meet Management in Cologne • September 20, 2016Page 29 PIONEER AF-PCI PCI Study Study title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention Objective: Safety of two Rivaroxaban regimens versus VKA after PCI (with stent placement) in non-valvular AF Rivaroxaban 15 mg od*# + Clopidogrel VKA (INR 2.0–3.0)§ + DAPT‡ N=2,100 1:1:1 R Population: Paroxysmal, persistent or permanent AF, undergoing PCI (with stent placement) Rivaroxaban 2.5 mg bid# + DAPT‡ Rivaroxaban 15 mg od* + low-dose ASA VKA + low-dose ASA End of treatment (12 months) Short design: Open-label, randomized, multicenter study Indication: SPAF/ACS Start: Q2’13 Completion: End 2016e * CrCl 30–49 ml/min: 10 mg od; # first dose 72–96 hours after sheath removal; ‡ ASA (75–100 mg daily) + Clopidogrel (75 mg daily) (alternative use of Prasugrel or Ticagrelor allowed, but capped at 15%); § first dose 12–72 hours after sheath removal; Gibson CM et al. AHJ 2014; www.clinicaltrials.gov/ct2/show/NCT01830543
  • 60. Meet Management in Cologne • September 20, 2016Page 30 PIONEER AF-PCI Study Details * Including but not limited to; # any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/ct2/show/NCT01830543; Gibson CM et al. AHJ 2014 • Composite of TIMI major bleeding events, minor bleeding events and bleeding events requiring medical attention Primary endpoint • History of paroxysmal, persistent or permanent non-valvular AF • Undergone PCI (with stent placement) for primary atherosclerotic disease Key inclusion criteria* • Prior stroke / TIA • Suspected or documented stent thrombosis during the index procedure or • has a PCI with stent placement for a pre- viously stented lesion (stent within a stent) during the index procedure or within the previous 12 months • Incomplete staged PCI procedure • CrCl <30 ml/min • Concomitant use of other anticoagulants Key exclusion criteria#
  • 61. Meet Management in Cologne • September 20, 2016Page 31 COMPASS CAD/PAD Study Study title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS – Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) Short design: Randomized, double-blind, controlled trial Indication: CAD/PAD Start: Q2’13 Completion: early 2018e * Patients treated according to local standard of care; # ≤30 days of the required pre-specified number of events having occurred; www.clinicaltrials.gov/show/NCT01776424 Objective: Efficacy and safety of Rivaroxaban, low-dose Rivaroxaban plus ASA or ASA alone for reducing risk of MI, stroke or cardiovascular death in CAD or PAD Rivaroxaban 2.5 mg bid + ASA 100 mg od ± pantoprazole 40 mg od ASA 100 mg od ± pantoprazole 40 mg od N~27,000 1:1:1 RPopulation: Documented CAD or PAD Rivaroxaban 5.0 mg bid ± pantoprazole 40 mg od Final washout period visit 30-day washout period* Final follow-up visit# 30-day run-in ASA 100mg
  • 62. Meet Management in Cologne • September 20, 2016Page 32 COMPASS Study Details # including but not limited to; ‡ any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/show/NCT01776424 • Composite of MI, stroke or cardiovascular death Primary efficacy endpoints • CAD or PAD plus ≥1 of: • Age ≥65 years • Age <65 years plus atherosclerosis in ≥2 vascular beds or ≥2 additional risk factors Key inclusion criteria# • Modified ISTH major bleeding Primary safety endpoint • Stroke ≤1 month or any haemorrhagic or lacunar stroke • Severe HF with known ejection fraction <30% or NYHA class III or IV symptoms • eGFR <15 ml/min • Concomitant use of other anticoagulants • Chronic treatment with non-ASA antiplatelet therapy Key exclusion criteria‡
  • 63. Meet Management in Cologne • September 20, 2016Page 33 COMMANDER HF Chronic HF/CAD Study Study title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Chronic Heart Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure Short design: Randomized, double-blind, placebo- controlled, parallel-group, multicenter, event-driven, superiority study Indication: HF/CAD Start: Q3’13 Completion: 1H 2018e * Date when 984 primary efficacy outcome events have occurred; www.clinicaltrials.gov/ct2/show/NCT01877915; study sponsor: Janssen Research & Development, LLC; Zannad F et al., Eur J Heart Fail 2015 Objective: Efficacy and safety of Rivaroxaban for reducing the risk of MI, stroke or death in HF with CAD Rivaroxaban 2.5 mg bid (single or dual antiplatelet therapy) Placebo (single or dual antiplatelet therapy) N=5,000 R Population: HF and CAD after recent hospitalization End of study visit 15–45-day follow-up Global treatment end date* ~6–30 months
  • 64. • Fatal bleeding, critical organ bleeding with potential for permanent disability • Composite MI, stroke or all-cause death Meet Management in Cologne • September 20, 2016Page 34 COMMANDER HF Study Details * Including but not limited to; # any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/ct2/show/NCT01877915; study sponsor: Janssen Research & Development, LLC; Zannad F et al., Eur J Heart Fail 2015 Primary efficacy endpoint • Symptomatic CHF ≥3 months and hospitalized for exacerbation of CHF • LVEF ≤40% ≤1 year • Significant CAD • Stable HF at randomization • Treatment according to guidelines Key inclusion criteria* Primary safety endpoint • Prior stroke ≤3 months • Index hospitalization >21 days • Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously • Concomitant use of other anticoagulants Key exclusion criteria#
  • 65. Objective: Efficacy and Safety of Rivaroxaban for the Reduction of Thrombotic Vascular Events in Subjects with PAD Undergoing Peripheral Revascularization Procedures Meet Management in Cologne • September 20, 2016Page 35 VOYAGER PAD PAD Study Study title: Rivaroxaban in a randomized, double blind, event driven superiority trial to show a significant reduction in thrombotic vascular events in patients with peripheral artery disease (PAD) Short design: Randomized, multicenter, prospective, double-blind, double-dummy, parallel-group, placebo-controlled, event-driven Indication: PAD Start: Q2’2015 Completion: early 2019e www.clinicaltrials.gov/ct2/show/NCT02504216 Rivaroxaban 2.5 mg bid + ASA 100 mg od ASA 100 mg od N~6,500 1:1 R Population: Patients with symptomatic PAD undergoing peripheral revascularization Study End 30 days Safety Follow-up Efficacy Cut-off Date Day 1 Event-driven study Mean treatment duration per patient: ~30 months
  • 66. Meet Management in Cologne • September 20, 2016Page 36 VOYAGER PAD Study Details * Including but not limited to; # any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/ct2/show/NCT02504216 • Composite of myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and major amputation of a vascular etiology Primary endpoint • Both genders, age ≥50 years • Documented moderate to severe symptomatic lower extremity peripheral artery occlusive disease • Technically successful peripheral infra-inguinal revascularization for symptomatic PAD within the last 7 days prior to randomization Key inclusion criteria* • Prior revascularization on the index leg within 8 weeks of the qualifying revascularization • Planned post-procedural co-administration of thienopyridines in addition to ASA (exc. Clopidogrel ≤30 days for the qualifying revascularization) • Confirmed ACS within the last 30 days • Any medically documented history of intracranial hemorrhage, stroke, or transient ischemic attack (TIA) Key exclusion criteria#
  • 67. Meet Management in Cologne • September 20, 2016Page 37 GEMINI ACS 1 ACS Study with Single vs. Dual APs Study title: A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome Short design: Multicentre, prospective, randomized, double-blind, double-dummy, active-controlled, parallel-group study Indication: ACS Start: Q2’2015 Completion: End 2016e / early 2017e Objective: Safety of Rivaroxaban in addition to either Clopidogrel or Ticagrelor in ACS www.clinicaltrials.gov/ct2/show/NCT02293395; study sponsor: Janssen Research & Development, LLC Population: Diagnosis of ACS 1:1 Clopidogrel + Rivaroxaban 2.5 mg BID Clopidogrel + ASA 30-day follow-up 180–360 days treatment SOC SOC R 1:1 Ticagrelor + Rivaroxaban 2.5 mg BID Ticagrelor + ASA 30-day follow-up 180–360 days treatment SOC SOC R Index hospi- talization: 1.Acute treatment: invasive or medical management 2.Maintenance dose ASA and P2Y12 inhibitor (Clopidogrel, Ticagrelor) Clopidogrel + ASA N=1,500 N=1,500 Ticagrelor + ASA ≤ 24h
  • 68. Meet Management in Cologne • September 20, 2016Page 38 GEMINI ACS 1 Study Details * including but not limited to; # any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labelling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/ct2/show/NCT02293395; study sponsor: Janssen Research & Development, LLC • Thrombolysis in Myocardial Infarction (TIMI) clinically significant bleeding Primary endpoint • Diagnosis of ACS • Acute treatment for ACS • Maintenance of dual antiplatelet treatment with either Clopidogrel plus ASA, or Ticagrelor plus ASA • Younger than 55 years of age must also have either diabetes mellitus, or a prior MI Key inclusion criteria* • Prior stroke of any etiology or TIA • Anticipated need for chronic administration of proton pump inhibitors (PPI) Omeprazole or Esomeprazole concomitantly with Clopidogrel. Other PPIs are allowed • Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the Ticagrelor stratum Key exclusion criteria#
  • 69. Meet Management in Cologne • September 20, 2016Page 39 EINSTEIN CHOICE Long-Term Secondary VTE Prevention Study Study title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism * Completed 6–12 months (±1 month) with interruption of anticoagulation ≤1 week at randomization; www.clinicaltrials.gov/ct2/show/NCT02064439; Weitz JI et al. Thromb Haemost 2015 Objective: efficacy and safety of reduced-dosed rivaroxaban, standard-dosed rivaroxaban versus ASA for the long-term secondary prevention of recurrent symptomatic VTE in patients with symptomatic DVT and/or PE Rivaroxaban 20 mg od N~950 N~950 N~3,300 R Population: DVT and / or PE after 6–12 months of anticoagulation* Rivaroxaban 10 mg od N~950 1 month observation period 12-month treatment duration Day 1 Short design: Multicentre, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority study Indication: VTEx Start: Q1’2014 Completion: End 2016e ASA 100 mg od
  • 70. • Major bleeding*• Fatal/non-fatal symptomatic recurrent VTE Meet Management in Cologne • September 20, 2016Page 40 EINSTEIN CHOICE Study Details * Bleeding definition – see notes; # including but not limited to; ‡ any other exclusion criteria in conjunction with the local product information and any other contraindication listed in the local labeling for Rivaroxaban or the comparator have to be considered; www.clinicaltrials.gov/ct2/show/NCT02064439; Weitz JI et al. Thromb Haemost 2015 Primary efficacy endpoint • Patients with confirmed symptomatic DVT and/or PE treated for 6–12 months (interruption ≤1 week) Key inclusion criteria# Primary safety endpoint • Life expectancy <6 months • Legal lower age limitations (country specific) • CrCl ≤30 ml/min • Concomitant use of other anticoagulants • Chronic treatment with antiplatelet therapy Key exclusion criteria‡
  • 71. Meet Management in Cologne • September 20, 2016Page 41 FXla Inhibition – Exploring a Novel Approach For Anti-Thrombotic Therapy Vessel wall injury Tissue Factor Factor Xa Amplification Thrombin Risk for vessel occlusion = Thrombosis Vessel injury coverage = Hemostasis FXIa FXIa inhibition blocks thrombosis, but not hemostasis • FXI pathway inhibition may have potential for antithrombotic therapy without increased bleeding risk • FXI pathway inhibition may offer an additional pathway for treating patients for whom there are currently no suitable therapeutic options available
  • 72. Meet Management in Cologne • September 20, 2016Page 42 Investigating New Approaches in Anticoagulation via FXI / FXIa Inhibition 1) In-licensed from IONIS-Pharmaceuticals 2) Prevention of thrombosis in patients undergoing total knee arthroplasty; Büller et al., NEJM (2015)372; 232 FXIRX Antisense Drug Candidate IONIS FXI 200 mg IONIS FXI 300 mg Enoxaparin 40 mg • Antisense oligonucleotide1 that specifically reduces the biosynthesis of clotting factor XI • Positive Phase II data2 Fully human IgG Anti-FXIa Antibody • 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 without affecting bleeding times • Status preclinical
  • 73. Meet Management in Cologne • September 20, 2016Page 43 Finerenone – Opportunity to Lead in Diabetic Kidney Disease DKD: diabetic kidney disease; CKD chronic kidney disease; MRA: mineralocorticoid receptor antagonist • Finerenone is a novel non-steroidal MRA with a differentiated profile • Steroidal MR antagonists are not approved for kidney diseases • A Finerenone phase IIb (ARTS-DN) study in Diabetic Nephropathy was successfully completed Finerenone  Significant need for innovative therapies  Phase III program in DKD progressing as planned • Market for chronic kidney disease estimated at ~$14bn in 2024 • Resulting complications from Diabetes accounting for 35% of CKD • ~40% of new cases of end-stage renal disease (ESRD) are due to Diabetes Mellitus (DM) • Patients with Type II DM and CKD are at high risk of cardiovascular (CV) death Diabetic Kidney Disease
  • 74. Meet Management in Cologne • September 20, 2016Page 44 Finerenone – Phase III Program 2 Event-Driven Outcome Trials Diabetic Kidney Disease • Type II Diabetes and CKD • DKD with high risk of developing CV events • Primary cardiovascular endpoint FIGARO-DKD • Type II Diabetes and CKD • DKD with high risk of progression of CKD and developing CV events • Primary renal endpoint FIDELIO-DKD DKD: diabetic kidney disease; CKD chronic kidney disease; CV: cardiovascular
  • 75. • FInerenone in reducing kiDnEy faiLure and dIsease prOgression in DKD • N~4,800 • Primary EP: composite of kidney failure, decrease of eGFR ≥40% from baseline or renal death Meet Management in Cologne • September 20, 2016Page 45 Finerenone – Phase III FIGARO-DKD and FIDELIO-DKD Trial – Design • FInerenone in reducinG cArdiovascular moRtality and mOrbidity in DKD • N~6,400 • Primary EP: composite of CV death or non-fatal CV events FIGARO-DKD FIDELIO-DKD
  • 76. Meet Management in Cologne • September 20, 2016Page 46 Vericiguat – Potential First-in-Class Treatment for Chronic Heart Failure • A lack of sGC stimulation leads to the reduced activity of the “nitric oxide- sGC-cGMP” pathway, causing coronary dysfunction and progressive myocardial damage • By directly stimulating the critical enzyme sGC, Vericiguat restores this pathway and in turn may improve heart and vascular function • Phase III (VICTORIA) trial assesses a potential reduction in mortality and morbidity on top of standard of care in HFrEF patients • VICTORIA trial initiated1 1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic heart failure; HFrEF: heart failure with reduced ejection fraction Novel approach targeting the critical cGMP cardiovascular pathway that is impaired in CHF patients
  • 77. Meet Management in Cologne • September 20, 2016Page 47 Vericiguat – Phase III Study Design (VICTORIA) Study objective: A randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of Vericiguat in participants with HFrEF. The primary hypothesis is Vericiguat is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF. HFrEF heart failure with reduced ejection fraction; www.clinicaltrials.gov/ct2/show/NCT02861534; study sponsor: Merck Sharp & Dohme Corp Starting dose of 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be uptitrated to 5 mg and to 10 mg R Population: Subjects with heart failure with reduced ejection fraction Day 1 Starting dose of placebo equivalent to 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be sham uptitrated to 5 mg and to 10 mg placebo equivalent Primary End Point: Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure Hospitalization VICTORIA: VerICiguaT glObal study in patients with heart failure and Reduced ejectIon frAction trial Study conducted in partnership with the Canadian VIGOUR Centre (CVC) at the University of Alberta and the Duke Clinical Research Institute (DCRI). Vericiguat Placebo Study End Event-driven study N~4,900
  • 78. Meet Management in Cologne • September 20, 2016Page 48 Proven Track Record of Successful Portfolio ManagementSummary Page 48 Meet Management Cologne • September 20, 2016 Leading Hemophilia Franchise
  • 79. Meet Management in Cologne • September 20, 2016Page 49 Modulating Hemostatic Balance in Hemophilia Bleeding Clotting In hemophilia and other bleeding disorders, clotting can be enhanced by: • Increase in procoagulant factors, e.g. factor VIII supplementation • Decrease in anticoagulant factors, e.g. inhibition of TFPI (Tissue Factor Pathway Inhibitor) Anticoagulant Factors Procoagulant Factors
  • 80. Meet Management in Cologne • September 20, 2016Page 50 Robust Innovation Pipeline in Hemophilia and Bleeding Disorders Kogenate Kovaltry (first launches in Q1–2016) Bay 94-9027 Damoctocog Alfa Pegol (long acting FVIII) Phase I Phase II Phase III Filed MarketedPreclinical FVIII supplementation Novel MoA Gene Therapy (Collaboration with Dimension Therapeutics) Anti-TFPI Antibody Bypass Therapy MoA: mode of action TFPI: tissue factor pathway inhibitor
  • 81. Meet Management in Cologne • September 20, 2016Page 51 Kovaltry – Initial Launch Shows Positive Response in EU, US and Japan • Kovaltry is an improved full-length rFVIII product allowing for prophylaxis treatment with as few as 2 per week application • Successfully launched in US, Canada, Japan as well as Germany and other EU markets during 1H’16 • Initial launch KPIs are positive with Kovaltry being chosen by both Kogenate and competitive brand customer for its efficacy and trust
  • 82. Meet Management in Cologne • September 20, 2016Page 52 TFPI-Inhibition as a Potential Novel Treatment Principle for Hemophilia A/B Role of TFPI in Coagulation anti-TFPI Facts • Can reversibly inhibit various clotting factors leading to bleeding • Inhibition of TFPI potentially offers novel treatment option for Hemophilia A/B patients with or without inhibitors • Hemophilia patients depend on extrinsic pathway for clotting. anti-TFPI Ab inhibits TFPI – thereby restoring impaired hemostasis • BAY1093884 is a fully human monoclonal antibody • Phase I ongoing TFPI: tissue factor pathway inhibitor
  • 83. Meet Management in Cologne • September 20, 2016Page 53 Proven Track Record of Successful Portfolio ManagementSummary Page 53 Meet Management Cologne • September 20, 2016 Well Positioned In Retinal Diseases
  • 84. Meet Management in Cologne • September 20, 2016Page 54 Well-Positioned in Retinal Diseases 1: marketed by Bayer ex-US only 2: source: IMS monthly market share data 3: in collaboration with Regeneron DME: Diabetic macula edema; mCNV: myopic Choroidal neovascularization; RVO: retinal vein occlusion; PDGFR: platelet-derived growth factor • Eylea1 gaining market share in multiple countries, achieving market leadership across the ex-US territories2 • Confident in growth potential – peak sales estimates raised to > €2.5bn • Life-cycle management including combination therapy with either PDGFR-β antibody3 or Ang2-antibody3
  • 85. Meet Management in Cologne • September 20, 2016Page 55 Eylea and PDGFR-ß-Antibody or Ang2- Antibody - Combination Therapy 1) In collaboration with Regeneron; 2) Kudelka et al. Exp Rev Ophthalmol.2013; 8(5):475-484; 3) Diago et al. Mayo Clin. Proc.2008; 83, 231-234; PDGF(R): platelet-derived growth factor (receptor); Ang2: angiopoietin 2 Eylea and a PDGFR-ß antibody co-formulation in wet AMD • Program currently in phase II1 • PDGF may induce maturation of pathological neovascularization through pericyte stimulation; showed experimentally to recruit pro- fibrotic cells in the eye and may therefore have a role in retinal scarring secondary to wet AMD2 • PDGF inhibition can potentially augment efficacy of VEGF inhibition in wet AMD3 Eylea and Ang2-antibody co-formulation in wet AMD and DME • 2 ongoing phase II programs1 evaluating the combination of co-formulated Eylea with the Ang2-antibody nesvacumab • Ang2 together with VEGF have the potential to influence pathological development of new blood vessels and the permeability of blood vessels in certain eye diseases
  • 86. Meet Management in Cologne • September 20, 2016Page 56 Proven Track Record of Successful Portfolio ManagementSummary Page 56 Meet Management Cologne • September 20, 2016 Striving for Segment Leadership in Oncology
  • 87. Meet Management in Cologne • September 20, 2016Page 57 Stivarga - Oral Multikinase Inhibitor with Distinct Profile Regorafenib is an oral multikinase inhibitor with a distinct profile targeting • Angiogenic (VEGFR1-3, TIE2) • Stromal (PDGFR-, FGFR) VEGFR: vascular endothelial growth factor receptor; TIE2: tyrosine kinase with immunoglobulin-like and EGF-like domains; PDGFR: platelet derived growth factor receptor; FGFR: fibroblast growth factor receptor • Oncogenic (KIT, PDGFR and RET) receptor tyrosine kinases Inhibition of proliferation of certain tumor cells Inhibition of stromal signalling Inhibition of neoangiogenesis
  • 88. Meet Management in Cologne • September 20, 2016Page 58 Stivarga - Oral Multikinase Inhibitor with Distinct Profile • Stivarga is approved* in: • >90 countries for metastatic colorectal cancer (mCRC) and in • >80 countries for advanced gastrointestinal stromal tumors (GIST) • Plan to file Regorafenib for 2L HCC in 2016 • Ongoing clinical development activities include • Phase III study in adjuvant CRC (ARGO study) * as of September 2016 HCC: hepatocellular cancer; (m)CRC: (metastatic) colorectal cancer
  • 89. Meet Management in Cologne • September 20, 2016Page 59 Stivarga Phase III Data 2L HCC* • RESORCE study met primary endpoint demonstrating that Regorafenib led to a stat. significant and clinically meaningful improvement in overall survival for patients with HCC who progressed on prior Nexavar treatment: • 38% reduction in the risk of death (HR 0.62; 95% CI 0.50-0.78; P <0.001) • Median OS 10.6 months vs. 7.8 months • Survival benefit was maintained in all predefined subgroups • PFS and TTP were significantly improved with Regorafenib • Patients treated with Regorafenib had significantly higher response rate and almost doubled disease control rate • Adverse events were manageable and consistent with the known Regorafenib safety profile * Bruix J. et al. presented at World Congress on Gastrointestinal Cancer 2016 HCC: hepatocellular cancer; OS: overall survival; HR: hazard ratio; PFS: progression free survival; TTP: time to progression
  • 90. Meet Management in Cologne • September 20, 2016Page 60 Expanding Xofigo’s Position in Castration- Resistant Prostate Cancer Treatment For details on approved indications see respective product labels; Zytiga® is a trademark of Johnson & Johnson Metastatic castration-resistant prostate cancer Asymptomatic bone metastases Potential new disease area for combination therapy Symptomatic bone metastases Xofigo (radium Ra 223 dichloride injection) Novel antihormonal agents (eg. Zytiga® [abiraterone]) Chemotherapy • Combination therapy with abiraterone, an inhibitor of testosterone synthesis • Expansion to earlier disease stages enhances accessible patient population • A delay of skeletal-related events is of major clinical importance
  • 91. Meet Management in Cologne • September 20, 2016Page 61 Addressing Multiple Life-Cycle Opportunities for Radium-223 Dichloride (Xofigo) CRPC: castration resistant prostate cancer Life-cycle opportunities Addressed through Phase II trial assessing the short and long-term safety of re-treatment Phase II trial with dose higher than the approved 50 kBq/kg Clinical studies in breast cancer, osteosarcoma, multiple myeloma and potentially other cancer types Phase III combination trial with Abiraterone Phase III trial in combination with Enzalutamide Repeat dosing in CRPC Higher dose in CRPC Expansion into additional cancer types Earlier disease stages of CRPC Combination studies in CRPC
  • 92. Meet Management in Cologne • September 20, 2016Page 62 Anetumab Ravtansine Program Advancing * Blumenschein et al. ASCO 2016; ADC: antibody drug conjugate Mode of action: • ADC targeting tumor-associated antigen mesothelin, and delivering toxophore DM4, which acts on proliferating cells (tubulin inhibitor) Potential spectrum of indications determined by mesothelin expression pattern: • mesotheliomas (100%) • pancreatic cancer (~80-100%) and • ovarian adenocarcinomas (~80%) Clinical program: • Phase I* with promising results including duration of treatment of > 1,000 days • Registrational phase II in metastatic pleural mesothelioma ongoing
  • 93. Meet Management in Cologne • September 20, 2016Page 63 Anetumab Ravtansine – Promising Profile Shown in Phase I* * Blumenschein et al; ASCO, 2016; PR: partial response; Q3W: three times per week; ORR: overall response rate; TEAE: treatment emergent adverse event; AE: adverse event • Single-agent anetumab ravtansine administered at 6.5 mg/kg Q3W to patients with advanced refractory solid tumors resulted in: • PRs in 7 patients (5 of 16 with mesothelioma [31% ORR] and 2 of 21 with advanced ovarian cancer [9.5% ORR]) • An acceptable safety profile; the most common drug-related TEAEs included fatigue, gastrointestinal AEs, ophthalmological AEs, peripheral neuropathy and elevated serum transaminases  A pivotal phase II trial for second-line therapy in metastatic pleural mesothelioma is ongoing
  • 94. Meet Management in Cologne • September 20, 2016Page 64 Anetumab Ravtansine – Phase II Design Study design • Randomized, open-label, active-controlled, two-arm, multicenter, Phase II trial (NCT02610140) to evaluate the safety and efficacy of single-agent Anetumab Ravtansine Patient selection criteria • Biomarker sampling on all patients at pre-screening; mesothelin expression levels need to exceed a predetermined threshold value
  • 95. • ODM-201 is a potent and full AR antagonist • Promising efficacy profile demonstrated in previous studies • Inhibits growth of prostate cancers in preclinical studies • Significantly decreases PSA levels in patients with progressive CRPC • Sustained PSA reduction was observed at higher dose levels • ODM-201 antagonizes mutant ARs linked to resistance to other AR antagonists (ie, bicalutamide, enzalutamide) • Phase III program ongoing addressing i. hormone sensitive metastatic prostate cancer ii. non-metastatic CRPC Meet Management in Cologne • September 20, 2016Page 65 ODM-201 – A Novel, New-Generation Nonsteroidal AR Antagonist AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen
  • 96. Meet Management in Cologne • September 20, 2016Page 66 Expanding Positioning in Prostate Cancer AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen; EBRT: external beam radiation therapy; ADT: androgen deprivation therapy; LHRH: luteinizing hormone-releasing hormone NON-METASTATIC (St I-III): ~10–15 years METASTATIC (St IV): ~2–4 years M0 Local disease M0 Untreated Rising PSA M0 Treated Biochemical relapse Rising PSA Newly diagnosed metastases CRPC Asympto- matic disease (failed ADT) CRPC Sympto- matic disease CRPC Post- docetaxel Surgery ± EBRT LHRH ADT ADT* / Chemo Novel Anti-Androgens Sipuleucel-T Chemotherapy XofigoStudies ARAMIS ARASENS
  • 97. Meet Management in Cologne • September 20, 2016Page 67 ODM-201 May Differentiate Through Low Blood-Brain Barrier Penetration * Rat autoradiography (QWBA) confirms brain/plasma ratio of 14C-ODM-201 related radioactivity was 0.04–0.06, indicating negligible penetration to the brain; † 14C-Abiraterone concentration measured in brain was 5–9 times higher than its concentration in blood and has been measured in cerebellum, cerebrum, medulla, and spinal cord 4) ‡ Clegg et al, Cancer Research. 2012;72:1494-1503; Foster, et al. The Prostate. 2011;71:480-488 1) Fizazi, et al. Lancet Oncol. 2014;15:975-985; 2) Moilanen, et al. Eur J Cancer. 2013;49(suppl 2);abst. 2869.; 3) Moilanen, et al. Sci Rep. 2015;5:12007. DOI: 10.1038/rep12007.; 4) European Medicines Agency Assessment Report for Zytiga Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002321/WC500112860.pdf • ODM-201 demonstrates negligible blood-brain barrier penetration in preclinical studies1-3 • ODM-201 has a low brain/plasma ratio in murine models3* • Reduced brain exposure may confer a lower risk of seizure with ODM-201 treatment than ARN-509 or enzalutamide1-3 Enzalutamide 19%‡ ARN-509 29%‡ ODM-201 + main metabolite 3%* Abiraterone†
  • 98. Meet Management in Cologne • September 20, 2016Page 68 ARAMIS Phase III of ODM-201 in nmCRPC nmCRPC: non-metastatic castration-resistant prostate cancer; PSA=prostate-specific antigen; MFS: metastasis free survival • Preventing the development of metastases in men with nmCRPC is a major unmet medical need, and preclinical and early-stage clinical studies suggest that ODM-201 is an effective and generally well-tolerated therapy • ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) is a phase 3 clinical trial examining the safety and efficacy of ODM-201 in men with nmCRPC at high risk for metastasis to determine if ODM-201 delays time to metastasis Study Design High-risk nmCRPC men Randomize Metastasis-free survival (primary endpoint) ODM-201 600 mg twice daily Placebo 2:1 Double-blind N~1,500 Stratification: PSADT (≤6 mo vs. >6 mo) Use of osteoclast-targeted therapy at time of enrollment: yes vs. no
  • 99. Meet Management in Cologne • September 20, 2016Page 69 ARASENS Phase III of ODM-201 in mHSPC mHSPC: metastatic hormone sensitive prostate cancer; AR: androgen receptor; ADT: androgen deprevation therapy; OS: overall survival; mCSPC: metastatic castration sensitive prostate cancer; ULN: upper limit of normal • ADT and docetaxel have recently demonstrated significant survival benefits with tolerable toxicities and is anticipated to become a new standard for subjects with mCSPC • The aim of the proposed study is to demonstrate that the addition of ODM-201 as second generation AR inhibitor to ADT and docetaxel chemotherapy significantly prolongs OS over placebo in mCSPC subjects Key Eligibility Criteria: • Metastatic prostate cancer • ADT started < 12 weeks before randomization (but no longer) • Candidates for ADT and docetaxel • ECOG 0-1 1:1 randomization Primary endpoint: OS ODM-201 600mg bid w/ ADT + docetaxel Placebo w/ ADT + docetaxel N=1,300 Stratification: Extent of disease • Non-regional lymph node metastasis only • Bone metastasis with or without lymph node metastasis • Visceral metastasis with or without lymph node or with or without bone metastasis Alkaline phosphatase • < ULN • ≥ ULN
  • 100. Meet Management in Cologne • September 20, 2016Page 70 Proven Track Record of Successful Portfolio ManagementSummary Page 70 Meet Management Cologne • September 20, 2016 Pipeline Overview
  • 101. Meet Management in Cologne • September 20, 2016Page 71 Pharma Pipeline With Attractive Assets in Areas of High Unmet Medical Need Selection of projects
  • 102. Erica Mann, Member of the Board of Management, Head of Consumer Health Investor Presentation – Consumer Health Meet Management in Cologne – September 20, 2016
  • 103. Meet Management in Cologne • September 20, 2016Page 2 Significant Pace of Change in the Self Care Market Aging & more educated population Consumer desire for healthcare empowerment and self care Expanding access via new geographies and channels Government / private sector desire to lower healthcare costs Rx-to-OTC switches
  • 104. Meet Management in Cologne • September 20, 2016Page 3 Consumer Health Advocating Self Care Education Risk Awareness ● Epidemiology ● Clinical picture ● Ways to address ● Publications ● Clinical Research ● Conferences ● Advocacy groups ● Organizations ● Jointly establish self care recommendations Alliances
  • 105. Meet Management in Cologne • September 20, 2016Page 4 History of Building Scale and Scope Organically and through Acquisitions BRC1 countries (2012-present) • Investments in organic growth MCC (2014)4 • US #1 position • Enter Allergy (leader), Suncare, Footcare Dihon (2014) • China #2 MNC position • Foothold into TCM3 Steigerwald (2013) • Naturals • Strengthen GI2 • International rollout Iberogast Roche (2005) • Europe • Strengthen Nutritionals, Derm Topsun (2008) • China infrastructure in retail and production Sagmel (2008) • CIS infrastructure 2004 2015 Sales €1.4bn €6.1bn Global Position #6 #16 Block- buster Brands5 3 16 Sources: internal data, Nicholas Hall / IRI 1 Brazil, Russia, China; 2 Gastrointestinal; 3 Traditional Chinese Medicine; 4 Merck & Co Consumer-Care; 5 over €100m annual sales; 6 OTC plus Suncare and Footcare; CIS: commonwealth of independent states; MNC: multinational companies
  • 106. 3.4 3.5 3.9 3.9 4.2 6.1 3.1 2010 2011 2012 2013 2014 2015 1H 2016 Meet Management in Cologne • September 20, 2016Page 5 Successfully Executed Growth Strategy  Outperformed market growth 2010-15  Acquisition of Merck’s Consumer Care business builds scale and scope in key geographies and categories  1H 2016 affected by sales decline in US, soft seasons and macroeconomic slowdown in key emerging markets OTC market: 4.4% CAGR* Consumer Health sales € billion; ∆% Fx & portfolio adjusted +7% +6% +4% +5% +6% +3% 1H 2016 *Source: Nicholas Hall
  • 107. Sales ∆ Fx & portfolio adjusted Meet Management in Cologne • September 20, 2016Page 6 FY 2016 Guidance Adjusted 2015 2016 (Update July) Sales €6.1bn Low- to mid-single-digit % increase to ~ €6bn EBITDA before special items €1.5bn Level with prior year Assuming end Q2 2016 Fx rates (USD 1.11); outlook depends on specific planning assumptions as detailed in the annual report
  • 108. Meet Management in Cologne • September 20, 2016Page 7 Mid-Term Aspirations 2018 2015 Aspiration 2018 Sales +6.1% to €6.1bn 4-5% CAGR (2015-2018) Adj. EBITDA margin 24.0% ~25% Sales ∆ Fx & portf. adjusted, EBITDA before special items Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
  • 109.  Digital / E-commerce  Customer excellence  Establish CH as a leader in consumer-centric innovation (e.g. pursue Rx-to-OTC switch)  Improve efficiency and effectiveness  Apply proven brand building excellence  Focus on well recognized brands and attractive categories  Drive performance in US  Address slowdown in key emerging markets Meet Management in Cologne • September 20, 2016Page 8 Best Positioned to Sustain Market Share Growth While Improving Profitability Build category leading brands Drive key market growth Accelerate innovation Enhance capabilities
  • 110. Meet Management in Cologne • September 20, 2016Page 9 US: Focus on Core Brands to Drive Growth US OTC market CH performance  Size €29bn (#1 OTC market globally)  ~3.0% 5-year CAGR  Recent market growth driven by Rx-to-OTC switches and relaunches  #1 position, 9.7%* market share  €2.5bn 2015 net sales  2.5% 5-year CAGR in-market sales CH current situation / challenges  Achieved market leadership with enviable portfolio of leading brands  Reinvestment in Coppertone and Dr. Scholl‘s  Soft cough, cold, allergy and start to sun seasons  Competitive reentry and activity CH execution plans  Extend innovation across broader range of activities, e.g. new channels, adjacencies  Turn around Coppertone and Dr. Scholl’s  Build on strong momentum on Claritin, Miralax, One A Day * Source: IRI including OTC plus Sun and Foot Care
  • 111. Meet Management in Cologne • September 20, 2016Page 10 Increase Profitability in Key Emerging Markets China Russia  Market size €20bn (#2 OTC market)  CH achieved critical mass in 5 years (€88m in 2011 to €346m in 2015)  OTC market slowing down to ~6% growth p.a. 2016-20  Market size €3bn (#6 OTC market)  Scaled up from zero to €228m within 10 years (organic / inorganic)  CH MNC market position #2  OTC market slowing down to ~8% growth p.a. 2016-20 Brazil  Market size €2.6bn (#9 OTC market)  Double-digit CH growth over past 4 years  CH MNC market position #6 (up from #10 in 2013)  OTC market slowing down to ~7% growth p.a. 2016-20 CH execution plans  Leverage scale to grow more profitably  Maintain prudent investments to position for future growth * Source: Nicholas Hall; MNC: multinational companies
  • 112. Meet Management in Cologne • September 20, 2016Page 11 Bayer Has a Portfolio of Strong Brands Source: N. Hall DB6, FY 2015 data * Includes total “Others” as defined by N. Hall & Co. Excludes Private Label and Venezuela, MNF: manufacturer # of OTC Brands Avg Sales Per Brand (€m) # of CH Brands by MNF Sales MNF Sales Criteria 10,120 165 92 19 11 < €50m* €100-250m €50-€100m €250-500m > €500m 7 70 153 361 693 100+ 8 8 3 1 Examples
  • 113. Roche OTC Sagmel Steigerwald Meet Management in Cologne • September 20, 2016Page 12 Bayer Has the DNA to Successfully Build Brands *CAGR (2005-2015) nominal *CAGR (2013-2015) currency-adjusted vs. Pro Forma 2013*CAGR (2009-2015) currency-adjusted Total Roche brands growth 2005-2015  7% CAGR nominal  +2% pts above market Total Sagmel brands growth 2009-2015  21% CAGR (Fx-adj.)  2x market Key brand growth 2009-2015 Total Steigerwald brands growth 2013-2015  19% CAGR c.a. (vs Pro Forma 2013)  Fast expansion to Russia • Strong brand-building efforts with differentiated marketing tools • Enhanced distribution coverage Key brand growth 2013-2015Key brand growth 2005-2015 • Geographic expansion • Efficiencies with scale & distribution • Consistent brand activation & investment • Scaled up business in Germany • International expansion CAGR* Aleve 6% Bepanthen 14% Berocca 10% Elevit 16% Supradyn 2% Redoxon 8% CAGR* Theraflex 17% Relief 19% Calcemin 18% CAGR* Iberogast 30%
  • 114. Compelling Consumer Activation Consumer-Centric Innovation Next generation launch with ClariSpray “Live Claritin Clear” campaign 1ST Rx brand to broadcast advertise Rx-to-OTC switch with powerful visual equity Alternate forms broaden appeal Steady introduction of new claims Antihistamine + decongestant launch 2015 advertising campaign drives growth worldwide Meet Management in Cologne • September 20, 2016Page 13 Consistently Growing Allergy Business
  • 115. Meet Management in Cologne • September 20, 2016Page 14 Expanding Elevit‘s Brand Equity Beyond Conception and Pregnancy Conception and Pregnancy Male Fertility Female Fertility Breastfeeding ACROSS THE ENTIRE JOURNEYREASSURANCE
  • 116. Meet Management in Cologne • September 20, 2016Page 15 Robust Innovation Pipeline Critical for Long-Term Success  Tailor development to needs of different product categories, e.g. nutritionals, vs OTCs, vs personal care  Build Rx-to-OTC switches pipeline  Provide new benefit areas to consumers
  • 117. Meet Management in Cologne • September 20, 2016Page 16 Adding Innovation from Diagnosis to Treatment and Prevention Bacterial Vaginosis Vaginal Yeast Infection Irritation and discomfort Diagnosis ENABLING WOMEN to confidently manage their intimate health holistically. Treatment Prevention Educate and empower Confidently choose the right treatment Smartly treat with a triple benefit Leading & proven effective innovative treatments Soothing and calming sensation Protect against future infections with probiotics
  • 118. Meet Management in Cologne • September 20, 2016Page 17 Enhancing Digital Capabilities
  • 119. Grow mid-term by: • Driving key market (US, BRC) growth • Building category-leading brands • Accelerating innovation • Increasing productivity / enhancing capabilities Leverage leadership position to actively drive change in self care industry Meet Management in Cologne • September 20, 2016Page 18 Summary BRC: Brazil, Russia, China Address current headwinds
  • 120. Meet Management Cologne • September 20, 2016Page 19 Proven Track Record of Successful Portfolio ManagementSummary Page 19 Meet Management Cologne • September 20, 2016 APPENDIX
  • 121. Brands Years Old 2015 Sales €m YOY change1 ~30 627 +56% ~115 4732 +1% ~20 413 +5% ~70 355 +12% ~40 267 +17% ~110 253 +19% ~80 251 -2% ~60 218 -6% ~70 211 +6% ~30 162 +46% Top 10 Brands 3,230 Meet Management in Cologne • September 20, 2016Page 20 Sales of Top 10 Brands 2015 1 Fx & portf. adjusted 2 incl. CH Cardio, excl. PH Cardio
  • 122. Meet Management in Cologne • September 20, 2016Page 21 Consumer Health Division - #1 Player in Highly Fragmented, Growing OTC Market in € billion 4.5% €108.9bn Bayer Sanofi/BI GroupingGSK J&J Pfizer RB P&G Takeda Taisho Novartis Other 12% 21% 14%23% 15% 15% Dermatology €13.3bn (+4.0%) CASF4 €22.8bn (+7.5%) Analgesics €15.5bn (+5.5%) Nutritionals €24.5bn (+4.2%) GI3 €16.0bn (+6.9%) Others €108.9bn (+6%) Market Positions 20151 Market Category Split 20152 4.4% 4.3% 4.2% 3.5% 2.5% 2.0% 1.1% 1.0% 0.8% 71.7% Source: Nicholas Hall & Company DB6, FY 2015 1 Market shares include Sanofi/BI Grouping 3 GI: Gastrointestinal 2 Growth 2015 vs 2014 4 CASF: Cold, Allergy, Sinus, Flu
  • 123. Meet Management in Cologne – September 20, 2016 Liam Condon, Member of the Boad of Management, Head of Crop Science Investor Presentation – Crop Science
  • 124. Highly Attractive Agriculture Industry Benefiting from Macro Trends (1) Nelson et. al. (2014); (2) FAO 2016 "Climate change and food security“; (3) This includes Seeds & Traits and Crop Protection €120 billion Estimated agriculture inputs market size by 2025 from ~€85bn in 2015(3) ~10 billion People on the planet by 2050 United Nations 2015 -17% Declining hectares of farmland per capita by 2050 From 0.218 ha/capita in 2015 to 0.181 ha/capita in 2050(2) Productivity increase required to feed the planet by 2050 FAO(2) +60% Biophysical effect of climate change shocks on yields by 2050 Nelson(1) / FAO(2) -17% Page 2 Meet Management in Cologne • September 20, 2016
  • 125. Delivering Enhanced Solutions for Next Generation of Farming Page 3 • Overcome increasing gap of demand and availability of skilled labor • Raise yield given the environmental conditions by taking right decisions on genetics, agronomic practices and input factors • Optimize input factors to protect natural resources • Manage agronomic volatility and better mitigate risks, e.g. weather and commodity prices Meet Management in Cologne • September 20, 2016 Increase Efficiency Optimize Yield Ensure Sustainability Manage Volatility • Smart combination and optimized usage of products • Based on agronomic advice and digital farming solutions Integrated Solutions • Excellence in chemistry and biology • High-tech breeding capabilities • Targeted genome optimization • Computational Life Science Valuable New Technologies +
  • 126. Creating a Global Leader in Agriculture Based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11); (1) Pro forma figures without impact of potential disposals; (2) Excludes Adama non-Ag sales;(3) Monsanto calendarized to December 2015 year-end; (4) Bayer 2015 as reported ~45% ~55% 23.1 14.8 14.6 12.7 10.4 5.8 (3) 2015 Pro Forma Sales (in € bn) (1) (2) BASF Ag Crop Protection Seeds & Traits Pro forma Pro forma Pro forma (4) ChemChina Ag Syngenta DuPont Ag Dow Ag Page 4 Meet Management in Cologne • September 20, 2016
  • 127. Targeting Above-Market Growth and Industry Leading Profitability Meet Management in Cologne • September 20, 2016Page 5 Combined company expected to deliver above market growth and underlying EBITDA margin of >30% after year 3 post closing(1) Broad Product Portfolio Truly Global Footprint Innovation Engine Integrated Solutions Substantial Synergy Potential (1) Not including any potential divestments
  • 128. Attractive Offering Across All Relevant Product Segments Page 6 SeedGrowth Insecticides Herbicides Fungicides Seeds & Traits Total Env. Science 10.4 12.7 23.1 141 10.2 2.9 6.5 1.6 1.1 0.8 2015 Pro Forma Sales (€bn)1 Bayer CS Monsanto Meet Management in Cologne • September 20, 2016 1based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11); Pro forma figures without impact of potential disposals; Monsanto calendarized to December 2015 year-end; Bayer 2015 as reported
  • 129. A Truly Global Footprint of the Combined Business Page 7 Asia Pacific Latin America Europe North America 10.5 5.8 4.7 2.1 1based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11) Pro forma figures without impact of potential disposals; Monsanto calendarized to December 2015 year-end; Bayer 2015 as reported; rounding errors may cause little differences Bayer CS + Monsanto Industry 45% 24% 25% 26% 20% 23% 9% 27% 2015 Sales Split Meet Management in Cologne • September 20, 2016 Total 10.4 12.7 23.1 2015 Pro Forma Sales (€bn)1 Bayer CS Monsanto
  • 130. Successful Integrated Solutions Need Best-in-Class Technology Offerings Seeds & Traits • Superior germplasm • Strong genetics and breeding capabilities Crop Protection incl. Biologics • Innovative chemistry for weed, pest and disease control • Strong Biologics portfolio Digital Farming • Extensive data collection and computation • Predictive analytics Integrated Solutions Page 8 Meet Management in Cologne • September 20, 2016
  • 131. • Improved yield • Optimized inputs • Sustainable farming • More convenience • Improved sourcing Advancing from Combined Offering to Integrated Solutions • Smart combination and optimized usage of products • Based on agronomic advice and Digital Farming • Innovation of integrated systems based on technologies optimally designed to work together • Ability to offer a broad variety of seed and chemical products • Combining sales forces and infrastructure across geographies Combined Offering Integrated Solutions Benefit to the Farmer From short-term to long-term Page 9 Meet Management in Cologne • September 20, 2016
  • 132. Combined Offering to Fully Address Farmers’ Needs Seeds Seed Treatment Weed Management Pest Management Disease Management Soybean plants with higher yield potential + Advanced and comprehensive technology input leveraged with season-long advice + (1) Pro forma combined portfolio The Soybean Brazil Example(1) Page 10 Meet Management in Cologne • September 20, 2016
  • 133. Combined Technologies Enable Integrated Solutions - Corn and Soy Example (1) Seeds, traits and crop protection, Bayer internal estimates; (2) Source: IHS Global, 05-2016 (3) Source: Phillips McDougall 07-2016; (4) Pro forma; (5) Chemical and biological • Broad-acre crops corn and soy account for ~40% of global ag market value(1) • Key growing regions are North/Latin America (~40% of corn and ~80% of soy global planted acres)(2), thereof > 85% of corn and soy acres is biotech seed(3) MonsantoBayer Bayer & Monsanto Combined Portfolio(4) CROP PROTECTION(5)BIOTECH TRAITS Pest Control Weed Control Yield & Stress Corn Soybean Pest Control Yield & Stress DIGITAL FARMING Disease Control SEEDS Weed Control Combined company with strong positions across all technologies offers high value capturing opportunity in corn and soy in key growing regions Market Page 11 Meet Management in Cologne • September 20, 2016
  • 134. 40+ Major Decisions to be Taken Through Each Planting Season Agronomic Decision Engine Captures and Analyzes Data… … And Makes Recommendations for Each Step of the Way Which seed variety to plant? What is the appropriate level of nutrients? When and how to optimize harvest? Historical Crop Yield Data "On-the-Ground" Sensors Satellite and UAV Monitoring Weather Data Soil Databases Data Capture and Analysis Digital Farming helps to improve on-farm decision-making and execution along the entire planting cycle, helping to maximize yields and improve sustainability Deliver timely hyper-local and field-specific information for  selecting the right varieties and seeding rate  plant growth protection measures  recognizing plant stress factors at an early stage Digital Farming Provides Data-Based Insights to Optimize Field Specific Decision-Making How to protect the plant? Page 12 Meet Management in Cologne • September 20, 2016
  • 135. Digital Farming Potential of Combined Portfolio Integrated solutions of Seeds & Traits and Crop Protection inputs based on optimized field-level prescriptions to improve on-site decision making and execution Combining Advanced Digital Farming Capabilities • Seeds & Planting scripts creator – improving operations • Nitrogen Advisor – optimized N-fertilizer use • Field-level weather information and notification – managing weather risks • >92 million acres enrolled already today • Leading pest, weed, disease modelling and analytics – increasing resource efficiency • Hyper-localized decision support tools – optimizing use of Crop Protection products Long-term Vision: Outcome-driven value proposition (e.g., “yield guarantee”, “disease-free acre”) Page 13 Meet Management in Cologne • September 20, 2016
  • 136. New types of products • Resistance-breaking herbicide systems based on innovative traits and chemistry • Novel macromolecules selectively targeting pests (e.g., sprayable RNAi) Data-based decision support • Advisory tools for on-farm decisions (e.g., choice of germplasm/seeds) • Crop Protection applications at ultra-high precision (e.g., down to single-plant level) Better / safer products • Beneficials-friendly products based on in- depth understanding of physiology Building Integrated Systems from Interdisciplinary Approaches Data Sciences & Engineering Ag equipment and data processing/evaluation • Robotics & Drones • Sensor Technology • Satellite Technology • Big Data AnalyticsBiological Sciences Chemical Sciences Data Sciences & Engineering New Integrated Systems Potential for faster and more efficient development of customized solutions for farmers Page 14 Meet Management in Cologne • September 20, 2016