Bayer AG Meet Management 2016 Investor Handout
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About This Presentation
Bayer AG Meet Management 2016-09-20 Investor Handout
Slide Content
Meet Management in Cologne – September 20, 2016
Werner Baumann, CEO of Bayer AG
Investor Presentation-Group
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-look ing statements. The factors that could cause actual results to
differ materially include the following: the risk that M onsanto Company’s (“Monsanto”) stockholders do not approve the
transaction; uncertainties as to the ti ming of the transaction; the possibility that the parties may be unable to achieve
expected synergies and operating efficiencies in the merger wit hin the expected timeframes or at all and to successfully
integrate Monsanto’s operations into those of Bayer Aktiengesell schaft (“Bayer”); such integration may be more difficult, time-
consuming or costly than expected; revenues following t he transaction may be lower than expected; operating costs,
customer loss and business disruption (including, without limitation, difficulties in maintaini ng relationships with employees,
customers, clients or suppliers) may be greater than expect ed following the transaction; the retention of certain key
employees at Monsanto; risks associated with the disrupti on 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 ex pected or on the anticipated schedule; the parties’ ability to
meet expectations regarding the timing, completion and acc ounting and tax treatments of the merger; the impact of
indebtedness incurred by Bayer in connection with the transac tion 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 factor s 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 availabl e on the Bayer website at www.bayer.com. Bayer assumes no
obligation to update the information in this communication, exc ept as otherwise required by law. Readers are cautioned not
to place undue reliance on these forward-looking st atements that speak only as of the date hereof. Cautionary Statements Regarding Forward-
Looking Information Meet Management in Cologne • September 20, 2016
materially from those projected or forecast in the forward-look ing statements. The factors that could cause actual results to
differ materially include the following: the risk that M onsanto Company’s (“Monsanto”) stockholders do not approve the
transaction; uncertainties as to the ti ming of the transaction; the possibility that the parties may be unable to achieve
expected synergies and operating efficiencies in the merger wit hin the expected timeframes or at all and to successfully
integrate Monsanto’s operations into those of Bayer Aktiengesell schaft (“Bayer”); such integration may be more difficult, time-
consuming or costly than expected; revenues following t he transaction may be lower than expected; operating costs,
customer loss and business disruption (including, without limitation, difficulties in maintaini ng relationships with employees,
customers, clients or suppliers) may be greater than expect ed following the transaction; the retention of certain key
employees at Monsanto; risks associated with the disrupti on 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 ex pected or on the anticipated schedule; the parties’ ability to
meet expectations regarding the timing, completion and acc ounting and tax treatments of the merger; the impact of
indebtedness incurred by Bayer in connection with the transac tion 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 factor s 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 availabl e on the Bayer website at www.bayer.com. Bayer assumes no
obligation to update the information in this communication, exc ept as otherwise required by law. Readers are cautioned not
to place undue reliance on these forward-looking st atements 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 avail able) may be obtained free of charge by
directing a request to Corporate Secretary, Monsanto Co mpany, 800 North Lindbergh Boulevard, St. Louis, Missouri 63167,
or by calling (314) 694-8148.
Monsanto, Bayer and their respective dire ctors 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 pro xy 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 indi rect 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
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 avail able) may be obtained free of charge by
directing a request to Corporate Secretary, Monsanto Co mpany, 800 North Lindbergh Boulevard, St. Louis, Missouri 63167,
or by calling (314) 694-8148.
Monsanto, Bayer and their respective dire ctors 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 pro xy 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 indi rect 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, 2016 Page 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
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 5Monsanto 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
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
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
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 8Acquisition 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, 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, 2016 Page 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
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, 2016 Page 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
reviewandmarket opportunity
•Strong DCF-based value creation
imperative
•Key performance indicatorsincluding
sales growth relative to market, core EPS
accretion and value generation
•No capital allocationto one business at
the cost of underinvestmentin another
business
•Proven integration/ separation
capabilities Portfolio Management Approach
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
reviewandmarket opportunity
•Strong DCF-based value creation
imperative
•Key performance indicatorsincluding
sales growth relative to market, core EPS
accretion and value generation
•No capital allocationto one business at
the cost of underinvestmentin 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, 2016 Page 11
Delivering Shareholder Value Through
Strong Execution
3.2
15.3
2004 2015
1.3
6.1
2004 2015
5.9
10.412.7
2004 2015
RebuiltPharma
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 Margin
1
21
30
24
21
~27
2
Sales, €bn
EBITDA Margin, % Increased market cap ~4x since 2004
3
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, 2016 Page 11
Delivering Shareholder Value Through
Strong Execution
3.2
15.3
2004 2015
1.3
6.1
2004 2015
5.9
10.412.7
2004 2015
RebuiltPharma
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 Margin
1
21
30
24
21
~27
2
Sales, €bn
EBITDA Margin, % Increased market cap ~4x since 2004
3
Meet Management in Cologne • September 20, 2016 Page 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
39.740.2
41.3
46.1
7.1
7.6
8.38.48.7
10.3
2010 2011 2012 2013 2014 2015
4.83
5.30
5.61
5.89
6.82
4.1920.2
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 (€)
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
39.740.2
41.3
46.1
7.1
7.6
8.38.48.7
10.3
2010 2011 2012 2013 2014 2015
4.83
5.30
5.61
5.89
6.82
4.1920.2
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, 2016 Page 13
H1 2016 –Successful Operating
Performance and Strategic Progress 2015 figures restated
Sales €m, % FX & portf. adj.
EBIT €m
+3%
23,687
23,769
H1’16 H1’15
+19%
4,458
3,748
H1’16 H1’15
EBITDA before special items, €m
Core EPS cont. operations, €
+11%
6,441
5,810
H1’16 H1’15
+9%
4.42
4.05
H1’16 H1’15
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
H1 2016 –Successful Operating
Performance and Strategic Progress 2015 figures restated
Sales €m, % FX & portf. adj.
EBIT €m
+3%
23,687
23,769
H1’16 H1’15
+19%
4,458
3,748
H1’16 H1’15
EBITDA before special items, €m
Core EPS cont. operations, €
+11%
6,441
5,810
H1’16 H1’15
+9%
4.42
4.05
H1’16 H1’15
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, 2016 Page 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€46.1bnLow-single-digit % increase to €46–47bn
Life Sciences€34.1bnMid-single-digit % increase to ~€35bn
Adj.
EBITDA
Group€10.3bnHigh-single-digit % increase
Life Sciences€8.6bnMid- to high-single-digit % increase
Core EPS
€6.82Mid- to high-single-digit % increase
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€46.1bnLow-single-digit % increase to €46–47bn
Life Sciences€34.1bnMid-single-digit % increase to ~€35bn
Adj.
EBITDA
Group€10.3bnHigh-single-digit % increase
Life Sciences€8.6bnMid- to high-single-digit % increase
Core EPS
€6.82Mid- to high-single-digit % increase
Meet Management in Cologne • September 20, 2016 Page 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
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, 2016 Page 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
RAD
1
Higher
R&D
Investment
2
Per-
formance
-0.8% pts
-0.6% pts
Fx
+0.3% pts
+1.1% pts
2018
Meet Management in Cologne • September 20, 2016 Page 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
RAD
1
Higher
R&D
Investment
2
Per-
formance
-0.8% pts
-0.6% pts
Fx
+0.3% pts
+1.1% pts
Meet Management in Cologne • September 20, 2016 Page 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
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, 2016 Page 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
Stivarga
Eylea
Adempas
Xofigo
Rec. Launched Products
Meet Management in Cologne • September 20, 2016 Page 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, 2016 Page 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
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, 2016 Page 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
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, 2016 Page 21
Key Takeaways Two Years After the Acquisition
of Merck & Co’sConsumer 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
Key Takeaways Two Years After the Acquisition
of Merck & Co’sConsumer 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, 2016 Page 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
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, 2016 Page 23
Significant Strategic Benefits Due to
Strong Position Along Key Criteria
A leading player with significant revenue base and high R&D spend
Scale
Broad product portfolio across indications and crops
Breadth
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
Significant Strategic Benefits Due to
Strong Position Along Key Criteria
A leading player with significant revenue base and high R&D spend
Scale
Broad product portfolio across indications and crops
Breadth
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, 2016 Page 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%
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, 2016 Page 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
1.71.7
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
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
1.71.7
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, 2016 Page 26
Key PharmaPipeline Assets With Combined
Peak Sales Potential of €6 billion
Pipeline ProjectIndication
Peak Sales
Potential Vericiguat
1
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 cancers
2
≥ €2.0bn
Copanlisib
Lymphoma
≥ €0.5bn
1)
In cooperation with Merck & Co.
2)
Ovarian, Mesothelioma, etc.
Key PharmaPipeline Assets With Combined
Peak Sales Potential of €6 billion
Pipeline ProjectIndication
Peak Sales
Potential Vericiguat
1
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 cancers
2
≥ €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, 2016 Page 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
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, 2016 Page 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, 2016 Page 28
Robust Consumer-Centric Innovation at
Consumer Health Examples only
ClariSpray
Aleve PM
Micro Active
Aspirin
Bepanthen
Sun
Berocca
On-the-Go
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, 2016 Page 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, 2016 Page 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
11.4
10.6
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 & Traits Crop Protection Total
3
Strong pipeline across crops, indications and technologies
Combined Strength in Innovation
2
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
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
11.4
10.6
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 & Traits Crop Protection Total
3
Strong pipeline across crops, indications and technologies
Combined Strength in Innovation
2
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, 2016 Page 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
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
Dieter Weinand, Member of the Board of Management, Head of Pharmaceuticals
Investor Presentation–Pharma
Meet Management in Cologne • September 20, 2016 Page 2
Fast-Growing Pharma Business
10.09.9
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%
Fast-Growing Pharma Business
10.09.9
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, 2016 Page 3
FY 2016 Guidance Increased
2015
2016
(update July)
Sales
€15.3bnHigh-single-digit % increase to >€16bn
Sales of Recently Launched
Products
€4.2bnToward €5.5bn
EBITDA before special items
€4.6bnLow-teens % increase
Adj. EBITDA margin30.1%
Improve
Assuming end Q2 2016 Fx rates (USD 1.11); Outlook depends on specific planning assump tions as detailed in the Annual Report;
2015 figures restatedSales ∆ Fx & portf. adjusted, adj. EBITDA margin = EBITDA before special items to sales
FY 2016 Guidance Increased
2015
2016
(update July)
Sales
€15.3bnHigh-single-digit % increase to >€16bn
Sales of Recently Launched
Products
€4.2bnToward €5.5bn
EBITDA before special items
€4.6bnLow-teens % increase
Adj. EBITDA margin30.1%
Improve
Assuming end Q2 2016 Fx rates (USD 1.11); Outlook depends on specific planning assump tions as detailed in the Annual Report;
2015 figures restatedSales ∆ Fx & portf. adjusted, adj. EBITDA margin = EBITDA before special items to sales
Meet Management in Cologne • September 20, 2016 Page 4
Mid-Term Aspirations 2018
2015Aspiration 2018
Sales
+9.1% to
€15.3bn
~6% CAGR (2015-2018)
Adj. EBITDA margin30.1%
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
Mid-Term Aspirations 2018
2015Aspiration 2018
Sales
+9.1% to
€15.3bn
~6% CAGR (2015-2018)
Adj. EBITDA margin30.1%
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, 2016 Page 5
Combined Peak Sales Potential of Recently
Launched Products Raised to >€10bn Combined peak sales potential for Xarelto, Stivarga, Eylea, Xofigo and Adempas assu ming 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 2
nd
line HCC
•Phase III in adjuvant CRC initiated
•Multiple LCM activities including
non-PH indications
•Continued successful
performance
Combined Peak Sales Potential of Recently
Launched Products Raised to >€10bn Combined peak sales potential for Xarelto, Stivarga, Eylea, Xofigo and Adempas assu ming 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 2
nd
line HCC
•Phase III in adjuvant CRC initiated
•Multiple LCM activities including
non-PH indications
•Continued successful
performance
Meet Management in Cologne • September 20, 2016 Page 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
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, 2016 Page 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
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, 2016 Page 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
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, 2016 Page 9
Xarelto –Peak Sales Potential Estimates
Raised -Again € billionPeak Sales Estimates
200720142016
•
Continued excellent performance –
Xarelto now a TOP 15 global Pharma
brand
1
•
>21 million patients treated since
launch
2
•
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
Xarelto –Peak Sales Potential Estimates
Raised -Again € billionPeak Sales Estimates
200720142016
•
Continued excellent performance –
Xarelto now a TOP 15 global Pharma
brand
1
•
>21 million patients treated since
launch
2
•
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, 2016 Page 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
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, 2016 Page 11
Finerenone–Opportunity to Lead in
Diabetic Kidney Disease DKD: diabetic kidney disease; CKD chronic kidney di sease; MRA: mineralocorticoid rec eptor 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
Finerenone–Opportunity to Lead in
Diabetic Kidney Disease DKD: diabetic kidney disease; CKD chronic kidney di sease; MRA: mineralocorticoid rec eptor 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, 2016 Page 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 initiated
1
1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic he art failure;
HFrEF: heart failure with reduced ejection fractionNovel approach targeting the critical cGMP cardiovascular
pathway that is impaired in CHF patients
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 initiated
1
1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic he art failure;
HFrEF: heart failure with reduced ejection fractionNovel approach targeting the critical cGMP cardiovascular
pathway that is impaired in CHF patients
Meet Management in Cologne • September 20, 2016 Page 13
Establish Focused Leadership Positions
in Oncology nmCRPC: non-metastatic castration resistant prostate cancer; LCM: life cycle management; ADC: antibody-drug conjugate; iNHL: indolen t 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 th rough capitalizing on optimal treatment
continuum / sequence for Nexavar & Stivarga in HCC
•
Differentiation for leadership in sele cted areas (Thorium platform; ADC’s)
•
Focus on differentiated programs
•
Stivarga HCC 2L launch 2017e
•
Copanlisib iNHLlaunch 2018e
•
Anetumab R. mesothelioma launch 2019e
•
Xofigo additional indications/uses
first launch 2019e
•
ODM-201 in nmCRPC
launch 2019e
Establish Focused Leadership Positions
in Oncology nmCRPC: non-metastatic castration resistant prostate cancer; LCM: life cycle management; ADC: antibody-drug conjugate; iNHL: indolen t 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 th rough capitalizing on optimal treatment
continuum / sequence for Nexavar & Stivarga in HCC
•
Differentiation for leadership in sele cted areas (Thorium platform; ADC’s)
•
Focus on differentiated programs
•
Stivarga HCC 2L launch 2017e
•
Copanlisib iNHLlaunch 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, 2016 Page 14
Expanding Xofigo’sPosition 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
Expanding Xofigo’sPosition 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, 2016 Page 15
ODM-201 –A Novel, New-Generation
Nonsteroidal AR Antagonist AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen
•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, 2016 Page 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, 2016 Page 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.
223
Ra
Decay
Targeted Thorium Conjugates (TTCs) Antibody Drug Conjugates (ADCs)
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.
223
Ra
Decay
Targeted Thorium Conjugates (TTCs) Antibody Drug Conjugates (ADCs)
Meet Management in Cologne • September 20, 2016 Page 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
Percent survival
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
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
Percent survival
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, 2016 Page 18
Anetumab Ravtansine Program Advancing
* Blumenschein et al. ASCO 2016; ADC: antibody drug conjugateMode 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
Anetumab Ravtansine Program Advancing
* Blumenschein et al. ASCO 2016; ADC: antibody drug conjugateMode 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, 2016 Page 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
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, 2016 Page 20
Proven Track Record of Successful
Portfolio Management Summary Page 20 Meet Management Cologne • September 20, 2016
APPENDIX
Proven Track Record of Successful
Portfolio Management Summary Page 20 Meet Management Cologne • September 20, 2016
APPENDIX
Meet Management in Cologne • September 20, 2016 Page 21
Proven Track Record of Successful
Portfolio Management Summary Page 21 Meet Management Cologne • September 20, 2016
Leading
Cardiovascular
Portfolio
Proven Track Record of Successful
Portfolio Management Summary 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, 2016 Page 22
Bayer –A Leading Player in Thrombosis
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, 2016 Page 22
Bayer –A Leading Player in Thrombosis
Meet Management in Cologne • September 20, 2016 Page 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
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, 2016 Page 24
Xarelto Life Cycle Management Studies:
Addressing Stroke Prevention
StudyIndication 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
Xarelto Life Cycle Management Studies:
Addressing Stroke Prevention
StudyIndication 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, 2016 Page 25
Xarelto Life Cycle Management Studies:
Addressing Arterial Thromboembolism
StudyIndication 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: unfra ctionated heparin; PCI: percutaneous coronary intervention
Xarelto Life Cycle Management Studies:
Addressing Arterial Thromboembolism
StudyIndication 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: unfra ctionated heparin; PCI: percutaneous coronary intervention
Meet Management in Cologne • September 20, 2016 Page 26
Xarelto Life Cycle Management Studies:
Addressing Venous Thromboembolism * current estimates on primary completion
StudyIndication 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
Xarelto Life Cycle Management Studies:
Addressing Venous Thromboembolism * current estimates on primary completion
StudyIndication 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, 2016 Page 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
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, 2016 Page 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
‡
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, 2016 Page 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 St rategy 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
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 St rategy 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, 2016 Page 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
#
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, 2016 Page 31
COMPASS
CAD/PAD Study Study title:A Randomized Controlled Trial of Rivaroxaban for the Prev ention 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
R
Population: 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
COMPASS
CAD/PAD Study Study title:A Randomized Controlled Trial of Rivaroxaban for the Prev ention 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
R
Population: 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, 2016 Page 32
COMPASS
Study Details
#
including but not limited to;
‡
any other exclusion criteria in conjunction with the local pr oduct 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
‡
COMPASS
Study Details
#
including but not limited to;
‡
any other exclusion criteria in conjunction with the local pr oduct 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, 2016 Page 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 St roke 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
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 St roke 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, 2016 Page 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
#
with potential for permanent disability
•Composite MI, stroke or all-cause death
Meet Management in Cologne • September 20, 2016 Page 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, 2016 Page 35
VOYAGER PAD
PAD Study Study title:Rivaroxaban in a randomized, double blind, event driven super iority 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
1:1R
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
Undergoing Peripheral Revascularization Procedures
Meet Management in Cologne • September 20, 2016 Page 35
VOYAGER PAD
PAD Study Study title:Rivaroxaban in a randomized, double blind, event driven super iority 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
1:1R
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, 2016 Page 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), i schemic 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
#
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), i schemic 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, 2016 Page 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
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, 2016 Page 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 (T IMI) 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
#
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 (T IMI) 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, 2016 Page 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, st andard-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
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, st andard-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, 2016 Page 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
‡
•Fatal/non-fatal symptomatic recurrent
VTE
Meet Management in Cologne • September 20, 2016 Page 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, 2016 Page 41
FXlaInhibition –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 inhibitionmay have potential for antithrombotic therapy without
increased bleeding risk
•FXI pathway inhibitionmay offer an additional pathway for treating patients
for whom there are currently no suit able therapeutic options available
FXlaInhibition –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 inhibitionmay have potential for antithrombotic therapy without
increased bleeding risk
•FXI pathway inhibitionmay offer an additional pathway for treating patients
for whom there are currently no suit able therapeutic options available
Meet Management in Cologne • September 20, 2016 Page 42
Investigating New Approaches in
Anticoagulation via FXI / FXIaInhibition
1)
In-licensed from IONIS-Pharmaceuticals
2)
Prevention of thrombosis in patients undergoing total knee arthroplasty; Büller et al., NEJM (2015)372; 232
FXI
RX
Antisense Drug Candidate
IONIS FXI
200 mg
IONIS FXI
300 mg
Enoxaparin
40 mg
•Antisense oligonucleotide
1
that specifically reduces
the biosynthesis of clotting factor XI
•Positive Phase II data
2
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
Investigating New Approaches in
Anticoagulation via FXI / FXIaInhibition
1)
In-licensed from IONIS-Pharmaceuticals
2)
Prevention of thrombosis in patients undergoing total knee arthroplasty; Büller et al., NEJM (2015)372; 232
FXI
RX
Antisense Drug Candidate
IONIS FXI
200 mg
IONIS FXI
300 mg
Enoxaparin
40 mg
•Antisense oligonucleotide
1
that specifically reduces
the biosynthesis of clotting factor XI
•Positive Phase II data
2
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, 2016 Page 43
Finerenone–Opportunity to Lead in
Diabetic Kidney Disease DKD: diabetic kidney disease; CKD chronic kidney di sease; MRA: mineralocorticoid rec eptor 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
Finerenone–Opportunity to Lead in
Diabetic Kidney Disease DKD: diabetic kidney disease; CKD chronic kidney di sease; MRA: mineralocorticoid rec eptor 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, 2016 Page 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–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 kiDnEyfaiLure 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, 2016 Page 45
Finerenone –Phase III FIGARO-DKD and
FIDELIO-DKD Trial –Design
•FInerenone in reducinGcArdiovascular
moRtality and mOrbidity in DKD
•N~6,400
•Primary EP:composite of CV death or
non-fatal CV events
FIGARO-DKD
FIDELIO-DKD
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, 2016 Page 45
Finerenone –Phase III FIGARO-DKD and
FIDELIO-DKD Trial –Design
•FInerenone in reducinGcArdiovascular
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, 2016 Page 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 initiated
1
1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic he art failure;
HFrEF: heart failure with reduced ejection fractionNovel approach targeting the critical cGMP cardiovascular
pathway that is impaired in CHF patients
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 initiated
1
1: study sponsor: Merck Sharp & Dohme Corp; cGMP: cyclic guanosine monophosphate; sGC: soluble guanylate cyclase; CHF: chronic he art failure;
HFrEF: heart failure with reduced ejection fractionNovel approach targeting the critical cGMP cardiovascular
pathway that is impaired in CHF patients
Meet Management in Cologne • September 20, 2016 Page 47
Vericiguat –
Phase III Study Design (VICTORIA) Study objective:A randomized, placebo-controlled, parallel-group, mu lti-center, double-blind, event driven study of
Vericiguat in participants with HFrEF. The pr imary hypothesis is Vericiguat is superio r 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: V erICiguaTglObal study in patients with heart failure and Reduced ejectIon fr Action 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
Vericiguat –
Phase III Study Design (VICTORIA) Study objective:A randomized, placebo-controlled, parallel-group, mu lti-center, double-blind, event driven study of
Vericiguat in participants with HFrEF. The pr imary hypothesis is Vericiguat is superio r 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: V erICiguaTglObal study in patients with heart failure and Reduced ejectIon fr Action 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, 2016 Page 48
Proven Track Record of Successful
Portfolio Management Summary Page 48 Meet Management Cologne • September 20, 2016
Leading
Hemophilia
Franchise
Proven Track Record of Successful
Portfolio Management Summary Page 48 Meet Management Cologne • September 20, 2016
Leading
Hemophilia
Franchise
Meet Management in Cologne • September 20, 2016 Page 49
Modulating Hemostatic Balance in Hemophilia
BleedingClotting
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
Modulating Hemostatic Balance in Hemophilia
BleedingClotting
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, 2016 Page 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 Marketed
Preclinical
FVIII supplementation
Novel MoA
Gene Therapy
(Collaboration with Dimension Therapeutics)
Anti-TFPI Antibody Bypass Therapy
MoA: mode of action
TFPI: tissue factor pathway inhibitor
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 Marketed
Preclinical
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, 2016 Page 51
Kovaltry–Initial Launch Shows Positive
Response in EU, US andJapan
•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
Kovaltry–Initial Launch Shows Positive
Response in EU, US andJapan
•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, 2016 Page 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
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, 2016 Page 53
Proven Track Record of Successful
Portfolio Management Summary Page 53 Meet Management Cologne • September 20, 2016
Well Positioned
In Retinal
Diseases
Proven Track Record of Successful
Portfolio Management Summary Page 53 Meet Management Cologne • September 20, 2016
Well Positioned
In Retinal
Diseases
Meet Management in Cologne • September 20, 2016 Page 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 •Eylea
1
gaining market share in multiple countries, achieving market
leadership across the ex-US territories
2
•
Confident in growth potential –peak sales estimates raised to > €2.5bn
•Life-cycle management including combination therapy with either
PDGFR- β antibody
3
or Ang2-antibody
3
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 •Eylea
1
gaining market share in multiple countries, achieving market
leadership across the ex-US territories
2
•
Confident in growth potential –peak sales estimates raised to > €2.5bn
•Life-cycle management including combination therapy with either
PDGFR- β antibody
3
or Ang2-antibody
3
Meet Management in Cologne • September 20, 2016 Page 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 II
1
•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 AMD
2
•PDGF inhibition can potentially augment efficacy of VEGF
inhibition in wet AMD
3
Eylea and Ang2-antibody co-formulation in wet AMD and DME
•2 ongoing phase II programs
1
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
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 II
1
•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 AMD
2
•PDGF inhibition can potentially augment efficacy of VEGF
inhibition in wet AMD
3
Eylea and Ang2-antibody co-formulation in wet AMD and DME
•2 ongoing phase II programs
1
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, 2016 Page 56
Proven Track Record of Successful
Portfolio Management Summary Page 56 Meet Management Cologne • September 20, 2016
Striving for
Segment
Leadership in
Oncology
Proven Track Record of Successful
Portfolio Management Summary Page 56 Meet Management Cologne • September 20, 2016
Striving for
Segment
Leadership in
Oncology
Meet Management in Cologne • September 20, 2016 Page 57
Stivarga -Oral MultikinaseInhibitor with
DistinctProfile 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
Stivarga -Oral MultikinaseInhibitor with
DistinctProfile 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, 2016 Page 58
Stivarga -Oral MultikinaseInhibitor with
DistinctProfile •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
Stivarga -Oral MultikinaseInhibitor with
DistinctProfile •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, 2016 Page 59
Stivarga
Phase III Data 2L HCC* •RESORCEstudy 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
•PFSand TTPwere 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 rati o; PFS: progression free survival; TTP: time to progression
Stivarga
Phase III Data 2L HCC* •RESORCEstudy 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
•PFSand TTPwere 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 rati o; PFS: progression free survival; TTP: time to progression
Meet Management in Cologne • September 20, 2016 Page 60
Expanding Xofigo’sPosition 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
Expanding Xofigo’sPosition 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, 2016 Page 61
AddressingMultiple Life-Cycle Opportunities
forRadium-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
AddressingMultiple Life-Cycle Opportunities
forRadium-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, 2016 Page 62
Anetumab Ravtansine Program Advancing
* Blumenschein et al. ASCO 2016; ADC: antibody drug conjugateMode 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
Anetumab Ravtansine Program Advancing
* Blumenschein et al. ASCO 2016; ADC: antibody drug conjugateMode 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, 2016 Page 63
AnetumabRavtansine–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: advers e 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
AnetumabRavtansine–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: advers e 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, 2016 Page 64
AnetumabRavtansine–Phase II Design Study design •Randomized, open-label, active-controlled, tw o-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
AnetumabRavtansine–Phase II Design Study design •Randomized, open-label, active-controlled, tw o-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, 2016 Page 65
ODM-201 –A Novel, New-Generation
Nonsteroidal AR Antagonist AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-specific antigen
•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, 2016 Page 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, 2016 Page 66
Expanding Positioning in Prostate Cancer AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-s pecific antigen; EBRT: external beam radiatio n 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
Xofigo
Studies
ARAMIS
ARASENS
Expanding Positioning in Prostate Cancer AR: androgen receptor; CRPC: castration-resistant prostate cancer; PSA: prostate-s pecific antigen; EBRT: external beam radiatio n 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
Xofigo
Studies
ARAMIS
ARASENS
Meet Management in Cologne • September 20, 2016 Page 67
ODM-201 May Differentiate Through
Low Blood-Brain Barrier Penetration * Rat autoradiography (QWBA) confirms brain/plasma ratio of
14
C-ODM-201 related radioactivity was 0.04–0.06, indicating negligible penetration
to the brain;
† 14
C-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.euro pa.eu/docs/en_GB/document_library/EPAR_-_Public _assessment_report/human/002321/WC500112860.pdf
•ODM-201 demonstrates negligible blood-brain barrier penetration in preclinical studies
1-3
•ODM-201 has a low brain/plasma ratio in murine models
3
*
•Reduced brain exposure may confer a lower risk of seizure with ODM-201 treatment than
ARN-509 or enzalutamide
1-3
Enzalutamide
19%
‡
ARN-509
29%
‡
ODM-201 + main
metabolite3%*
Abiraterone
†
ODM-201 May Differentiate Through
Low Blood-Brain Barrier Penetration * Rat autoradiography (QWBA) confirms brain/plasma ratio of
14
C-ODM-201 related radioactivity was 0.04–0.06, indicating negligible penetration
to the brain;
† 14
C-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.euro pa.eu/docs/en_GB/document_library/EPAR_-_Public _assessment_report/human/002321/WC500112860.pdf
•ODM-201 demonstrates negligible blood-brain barrier penetration in preclinical studies
1-3
•ODM-201 has a low brain/plasma ratio in murine models
3
*
•Reduced brain exposure may confer a lower risk of seizure with ODM-201 treatment than
ARN-509 or enzalutamide
1-3
Enzalutamide
19%
‡
ARN-509
29%
‡
ODM-201 + main
metabolite3%*
Abiraterone
†
Meet Management in Cologne • September 20, 2016 Page 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 studi es 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
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 studi es 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, 2016 Page 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 c hemotherapy 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
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 c hemotherapy 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, 2016 Page 70
Proven Track Record of Successful
Portfolio Management Summary Page 70 Meet Management Cologne • September 20, 2016
Pipeline
Overview
Proven Track Record of Successful
Portfolio Management Summary Page 70 Meet Management Cologne • September 20, 2016
Pipeline
Overview
Meet Management in Cologne • September 20, 2016 Page 71
Pharma Pipeline With Attractive Assets
in Areas of High Unmet Medical Need
Selection of projects
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
Investor Presentation –Consumer Health
Meet Management in Cologne – September 20, 2016
Meet Management in Cologne • September 20, 2016 Page 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
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, 2016 Page 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
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, 2016 Page 4
History of Building ScaleandScope
Organicallyand throughAcquisitions
BRC
1
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 TCM
3
Steigerwald (2013)
•Naturals
•Strengthen GI
2
•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 #1
6
Block-
buster
Brands
5
316
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
History of Building ScaleandScope
Organicallyand throughAcquisitions
BRC
1
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 TCM
3
Steigerwald (2013)
•Naturals
•Strengthen GI
2
•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 #1
6
Block-
buster
Brands
5
316
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
3.93.9
4.2
6.1
3.1 2010 2011 2012 2013 2014 2015 1H
2016
Meet Management in Cologne • September 20, 2016 Page 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
3.5
3.93.9
4.2
6.1
3.1 2010 2011 2012 2013 2014 2015 1H
2016
Meet Management in Cologne • September 20, 2016 Page 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, 2016 Page 6
FY 2016 Guidance Adjusted
2015
2016
(Update July)
Sales€6.1bn
Low- to mid-single-digit
% increase to ~ €6bn
EBITDA
before special items
€1.5bnLevel 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, 2016 Page 6
FY 2016 Guidance Adjusted
2015
2016
(Update July)
Sales€6.1bn
Low- to mid-single-digit
% increase to ~ €6bn
EBITDA
before special items
€1.5bnLevel 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, 2016 Page 7
Mid-Term Aspirations 2018
2015Aspiration 2018
Sales
+6.1% to
€6.1bn
4-5% CAGR (2015-2018)
Adj. EBITDA margin24.0%~25%
Sales ∆ Fx & portf. adjusted, EBITDA before special items
Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
Mid-Term Aspirations 2018
2015Aspiration 2018
Sales
+6.1% to
€6.1bn
4-5% CAGR (2015-2018)
Adj. EBITDA margin24.0%~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, 2016 Page 8
Best Positioned to Sustain Market Share
Growth While Improving Profitability
Build category
leading brands
Drive key market growth Accelerate innovation Enhance capabilities
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, 2016 Page 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, 2016 Page 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
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, 2016 Page 10
IncreaseProfitabilityin 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
IncreaseProfitabilityin 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, 2016 Page 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
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, 2016 Page 12
Bayer HastheDNA toSuccessfullyBuild
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 2013-2015
Key brand growth 2005-2015
•Geographic expansion
•Efficiencies with scale & distribution
•Consistent brand activation & investment
•Scaled up business in Germany
•International expansion
CAGR*
A
leve6%
Bepanthen14%
Berocca10%
Elevit16%
Supradyn2%
Redoxon8%
CAGR*
Theraflex17%
Relief19%
Calcemin18%
CAGR*
Iberogast30%
Sagmel
Steigerwald
Meet Management in Cologne • September 20, 2016 Page 12
Bayer HastheDNA toSuccessfullyBuild
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 2013-2015
Key brand growth 2005-2015
•Geographic expansion
•Efficiencies with scale & distribution
•Consistent brand activation & investment
•Scaled up business in Germany
•International expansion
CAGR*
A
leve6%
Bepanthen14%
Berocca10%
Elevit16%
Supradyn2%
Redoxon8%
CAGR*
Theraflex17%
Relief19%
Calcemin18%
CAGR*
Iberogast30%
Compelling Consumer Activation
Consumer-Centric Innovation
Next generation launch with ClariSpray
“Live Claritin Clear” campaign
1
ST
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, 2016 Page 13
Consistently Growing Allergy Business
Consumer-Centric Innovation
Next generation launch with ClariSpray
“Live Claritin Clear” campaign
1
ST
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, 2016 Page 13
Consistently Growing Allergy Business
Meet Management in Cologne • September 20, 2016 Page 14
ExpandingElevit‘sBrand Equity Beyond
ConceptionandPregnancy
Conception
and Pregnancy
Male
Fertility
Female
Fertility
Breastfeeding
ACROSS THE ENTIRE JOURNEY
REASSURANCE
ExpandingElevit‘sBrand Equity Beyond
ConceptionandPregnancy
Conception
and Pregnancy
Male
Fertility
Female
Fertility
Breastfeeding
ACROSS THE ENTIRE JOURNEY
REASSURANCE
Meet Management in Cologne • September 20, 2016 Page 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
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, 2016 Page 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
Smartlytreat with a
triple benefit
Leading & proven
effective innovative
treatments
Soothingand
calming sensation
Protect against
future infections
with probiotics
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
Smartlytreat with a
triple benefit
Leading & proven
effective innovative
treatments
Soothingand
calming sensation
Protect against
future infections
with probiotics
Meet Management in Cologne • September 20, 2016 Page 17
Enhancing Digital Capabilities
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, 2016 Page 18
Summary BRC: Brazil, Russia, China
Address
current
headwinds
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, 2016 Page 18
Summary BRC: Brazil, Russia, China
Address
current
headwinds
Meet Management Cologne • September 20, 2016 Page 19
Proven Track Record of Successful
Portfolio Management Summary Page 19 Meet Management Cologne • September 20, 2016
APPENDIX
Proven Track Record of Successful
Portfolio Management Summary Page 19 Meet Management Cologne • September 20, 2016
APPENDIX
Brands Years Old 2015 Sales €m YOY change
1
~30627+56%
~115473
2
+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, 2016 Page 20
Sales of Top 10 Brands 2015
1
Fx & portf. adjusted
2
incl. CH Cardio, excl. PH Cardio
1
~30627+56%
~115473
2
+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, 2016 Page 20
Sales of Top 10 Brands 2015
1
Fx & portf. adjusted
2
incl. CH Cardio, excl. PH Cardio
Meet Management in Cologne • September 20, 2016 Page 21
Consumer Health Division -#1 Player in Highly
Fragmented, Growing OTC Market
in € billion
4.5%
€108.9bn
Bayer
Sanofi/BI Grouping
GSK
J&J
Pfizer
RB
P&G
Takeda
Taisho
Novartis
Other
12%
21%
14%
23%
15%
15%
Dermatology
€13.3bn
(+4.0%)
CASF
4
€22.8bn (+7.5%)
Analgesics
€15.5bn
(+5.5%)
Nutritionals
€24.5bn
(+4.2%)
GI
3
€16.0bn (+6.9%)
Others
€108.9bn
(+6%)
Market Positions 2015
1
Market Category Split 2015
2
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
Consumer Health Division -#1 Player in Highly
Fragmented, Growing OTC Market
in € billion
4.5%
€108.9bn
Bayer
Sanofi/BI Grouping
GSK
J&J
Pfizer
RB
P&G
Takeda
Taisho
Novartis
Other
12%
21%
14%
23%
15%
15%
Dermatology
€13.3bn
(+4.0%)
CASF
4
€22.8bn (+7.5%)
Analgesics
€15.5bn
(+5.5%)
Nutritionals
€24.5bn
(+4.2%)
GI
3
€16.0bn (+6.9%)
Others
€108.9bn
(+6%)
Market Positions 2015
1
Market Category Split 2015
2
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
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
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
+
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 (a t 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
Based on company information and internal calculations (a t 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
TargetingAbove-Market Growth andIndustry
LeadingProfitability
Meet Management in Cologne • September 20, 2016 Page 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
LeadingProfitability
Meet Management in Cologne • September 20, 2016 Page 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
12.723.1
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
1
based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11);
Pro forma figures without impact of potent ial disposals; Monsanto calendarized to
December 2015 year-end; Bayer 2015 as reported
Segments
Page 6
SeedGrowth
Insecticides
Herbicides
Fungicides
Seeds & Traits
Total
Env. Science
10.4
12.723.1
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
1
based on company information and internal calculations (at avg. 2015 Fx rate USD/EUR=1.11);
Pro forma figures without impact of potent ial disposals; Monsanto calendarized to
December 2015 year-end; Bayer 2015 as reported
A Truly Global Footprint of the Combined
Business
Page 7Asia Pacific
Latin America
Europe
North America
10.5
5.8
4.7
2.1
1
based 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
+ MonsantoIndustry
45% 24%
25% 26%
20% 23%
9% 27%
2015 Sales Split
Meet Management in Cologne • September 20, 2016
Total
10.4
12.723.1
2015 Pro Forma Sales (€bn)
1
Bayer CS Monsanto
Business
Page 7Asia Pacific
Latin America
Europe
North America
10.5
5.8
4.7
2.1
1
based 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
+ MonsantoIndustry
45% 24%
25% 26%
20% 23%
9% 27%
2015 Sales Split
Meet Management in Cologne • September 20, 2016
Total
10.4
12.723.1
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
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
•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
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)
Monsanto
Bayer
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
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)
Monsanto
Bayer
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
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 prescriptionsto 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
Portfolio
Integrated solutions of Seeds & Traits and Crop Protection inputs based on optimized
field-level prescriptionsto 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 Analytics
Biological
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
•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 Analytics
Biological
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
2.5
1.6
1.3
0.7
Bayer CS +
Monsanto
Dow Ag +
DuPont Ag
Syngenta +
ChemChina
Ag
BASF Ag
11.4%
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 & Traits Crop Protection Total
(3)
(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
Strong pipeline across crops, indications and technologies
Combined Strength in Innovation
(2)
Creation of a Leading Innovator
10.6% 10.6%
Page 15 Meet Management in Cologne • September 20, 2016
1.6
1.3
0.7
Bayer CS +
Monsanto
Dow Ag +
DuPont Ag
Syngenta +
ChemChina
Ag
BASF Ag
11.4%
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 & Traits Crop Protection Total
(3)
(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
Strong pipeline across crops, indications and technologies
Combined Strength in Innovation
(2)
Creation of a Leading Innovator
10.6% 10.6%
Page 15 Meet Management in Cologne • September 20, 2016
Combined Company Has a Broad Pipeline:
Example Soybean
Biotech
Breeding Breeding
≥ 3 projects
≥ 3 projects
≥ 3 projects
≥ 3 projects
Breeding
Biotech
Crop Protection
≥ 3 projects
≥ 3 projects
Breeding
new varieties
Biotech
≥ 3 projects ≥ 3 projects
≥ 3 projects
Breeding
PEST
CONTROL
WEED
CONTROL
DISEASE
CONTROL
YIELD &
STRESS
(2)
GERMPLASM OIL QUALITY
Biotech
Crop Protection
≥ 3 projects
≥ 3 projects
Crop ProtectionCrop Protection
≥ 3 projects
Soy projects Pro forma
(1)
(1) Pro forma core soy pipeline only; not exhaustive; (2) Crop Efficiency; (3) Bayer: Top LCM products only
Crop Protection: chemical and biological; Breeding: incl. selective native traits; Biotech: GM traits
Late Research
Development
Life Cycle Mgmt.
(3)
Page 16 Meet Management in Cologne • September 20, 2016
Example Soybean
Biotech
Breeding Breeding
≥ 3 projects
≥ 3 projects
≥ 3 projects
≥ 3 projects
Breeding
Biotech
Crop Protection
≥ 3 projects
≥ 3 projects
Breeding
new varieties
Biotech
≥ 3 projects ≥ 3 projects
≥ 3 projects
Breeding
PEST
CONTROL
WEED
CONTROL
DISEASE
CONTROL
YIELD &
STRESS
(2)
GERMPLASM OIL QUALITY
Biotech
Crop Protection
≥ 3 projects
≥ 3 projects
Crop ProtectionCrop Protection
≥ 3 projects
Soy projects Pro forma
(1)
(1) Pro forma core soy pipeline only; not exhaustive; (2) Crop Efficiency; (3) Bayer: Top LCM products only
Crop Protection: chemical and biological; Breeding: incl. selective native traits; Biotech: GM traits
Late Research
Development
Life Cycle Mgmt.
(3)
Page 16 Meet Management in Cologne • September 20, 2016
Combined Entity Expected to Deliver
Synergies of Approx. $1.5bn After Year Three
Cost Synergies Breakdown
Synergy Breakdown
(Net EBITDA Impact
(1)
)
Total Sales Synergies ~$0.3bn Total Synergies~$1.5bn
Synergies are above and beyond Monsanto’s
announced restructuring program
Total Cost Synergies~$1.2bn
~$1.5bn total annual synergies after year thr ee confirmed in due diligence, plus additional
synergies from integrated solutions in future years
(1) Net of estimated dissynergies such as termination of selected distribution agreements as
well as sales disruptions (based on detailed bottom-up analysis by Bayer);
Fx rate: USD/EUR=1.11
•
~70% stemming from SG&A savings ‒
Integration of country platforms / IT land-
scape
‒
Public company expenses
‒
Overlapping marketing & sales functions
while maintaining exceptional global
footprint for future growth
•
R&D synergies, e.g. in trait research
•
COGS synergies, e.g. from overlap in
supply function & procurement spend
Page 17 Meet Management in Cologne • September 20, 2016
Synergies of Approx. $1.5bn After Year Three
Cost Synergies Breakdown
Synergy Breakdown
(Net EBITDA Impact
(1)
)
Total Sales Synergies ~$0.3bn Total Synergies~$1.5bn
Synergies are above and beyond Monsanto’s
announced restructuring program
Total Cost Synergies~$1.2bn
~$1.5bn total annual synergies after year thr ee confirmed in due diligence, plus additional
synergies from integrated solutions in future years
(1) Net of estimated dissynergies such as termination of selected distribution agreements as
well as sales disruptions (based on detailed bottom-up analysis by Bayer);
Fx rate: USD/EUR=1.11
•
~70% stemming from SG&A savings ‒
Integration of country platforms / IT land-
scape
‒
Public company expenses
‒
Overlapping marketing & sales functions
while maintaining exceptional global
footprint for future growth
•
R&D synergies, e.g. in trait research
•
COGS synergies, e.g. from overlap in
supply function & procurement spend
Page 17 Meet Management in Cologne • September 20, 2016
Substantial Longer-Term Synergies from
Integrated Solutions Anticipated
After year 3
Fx rate: USD/EUR=1.11
•
Creates an enhanced agricultural
offering to address broad range of
farmer needs
•
Initial sales synergies expected
mainly from broader product
variety materializing already near-
term(~$0.3bn net EBITDA impact)
•
Sales synergies expected to
expand in the mid to long-term
from integrated solutions •
Smart combinations
•
Innovation of integrated
systems
Net EBITDA Impact of Synergies
From Combined Offering to
Integrated Solutions
Long-term After year 3
~$1.5bn
EBITDA impact of
Cost Synergies
EBITDA impact of
Sales Synergies
Bottom line impact of
integrated solution benefits
expected to increase over
time
Page 18 Meet Management in Cologne • September 20, 2016
Integrated Solutions Anticipated
After year 3
Fx rate: USD/EUR=1.11
•
Creates an enhanced agricultural
offering to address broad range of
farmer needs
•
Initial sales synergies expected
mainly from broader product
variety materializing already near-
term(~$0.3bn net EBITDA impact)
•
Sales synergies expected to
expand in the mid to long-term
from integrated solutions •
Smart combinations
•
Innovation of integrated
systems
Net EBITDA Impact of Synergies
From Combined Offering to
Integrated Solutions
Long-term After year 3
~$1.5bn
EBITDA impact of
Cost Synergies
EBITDA impact of
Sales Synergies
Bottom line impact of
integrated solution benefits
expected to increase over
time
Page 18 Meet Management in Cologne • September 20, 2016
Combined Crop Science Company Well
Positioned to Deliver Excellent Performance
Meet Management in Cologne • September 20, 2016 Page 19A Global Leader
in Agriculture
Global Leader in Agriculture with broad product portfolio
and an integrated agricultural offering
Deliver Value
Proposition
Deliver above market growth and underlying EBITDA margin of >30% after year 3 post closing
(1)
Expect to earn cost of capital after year 4 post closing
Integrated
Solutions
Fully leverage combinations and optimized usage of products based on agronomic advice and digital farming
Innovation
Engine
Deploy joint innovation capabilities to deliver enhanced solutions for the next generation of farming
(1) Not including any potential divestments
Positioned to Deliver Excellent Performance
Meet Management in Cologne • September 20, 2016 Page 19A Global Leader
in Agriculture
Global Leader in Agriculture with broad product portfolio
and an integrated agricultural offering
Deliver Value
Proposition
Deliver above market growth and underlying EBITDA margin of >30% after year 3 post closing
(1)
Expect to earn cost of capital after year 4 post closing
Integrated
Solutions
Fully leverage combinations and optimized usage of products based on agronomic advice and digital farming
Innovation
Engine
Deploy joint innovation capabilities to deliver enhanced solutions for the next generation of farming
(1) Not including any potential divestments
Meet Management in Cologne – September 20, 2016
Investor Presentation–AnimalHealth
Investor Presentation–AnimalHealth
977
1,120
1,186
1,3031,3061,318
1,490
834
2009 2010 2011 2012 2013 2014 20151H’16
Meet Management in Cologne • September 20, 2016 Page 2
Animal Health –
A Strong Player in an Attractive Market CAP: companion animal products
FAP: food animal products
•Overall global #5and global #2in
parasiticides
•Ranked #3in CAP(~60% of sales)
•Sector driven by:
•Emotional relationships to pets
•Infectious and chronic diseases
•Ranked #6in FAP(~40% of sales)
•Sector driven by:
•Increasing customer / consumer
awareness
•Food safety & disease transmission
•Globalization in farm exports
Highlights
+6%
€ million; ∆% yoy Fx & portfolio adjusted
Sales
1,120
1,186
1,3031,3061,318
1,490
834
2009 2010 2011 2012 2013 2014 20151H’16
Meet Management in Cologne • September 20, 2016 Page 2
Animal Health –
A Strong Player in an Attractive Market CAP: companion animal products
FAP: food animal products
•Overall global #5and global #2in
parasiticides
•Ranked #3in CAP(~60% of sales)
•Sector driven by:
•Emotional relationships to pets
•Infectious and chronic diseases
•Ranked #6in FAP(~40% of sales)
•Sector driven by:
•Increasing customer / consumer
awareness
•Food safety & disease transmission
•Globalization in farm exports
Highlights
+6%
€ million; ∆% yoy Fx & portfolio adjusted
Sales
Meet Management in Cologne • September 20, 2016 Page 3
Animal Health –
Global Trends Drive Growth Opportunities
•Pet well-being – “family”- members
•Convenience & Quality of Life
•Resistance breaking parasiticides
•Emerging resistance to antibiotics –
alternatives to antibiotics
•Robust prevention and control
of infectious diseases
•Improved productivity &
cost-benefit ratio
•Safe and sustainable food Trends driving needs …
Animal Health –
Global Trends Drive Growth Opportunities
•Pet well-being – “family”- members
•Convenience & Quality of Life
•Resistance breaking parasiticides
•Emerging resistance to antibiotics –
alternatives to antibiotics
•Robust prevention and control
of infectious diseases
•Improved productivity &
cost-benefit ratio
•Safe and sustainable food Trends driving needs …
Meet Management in Cologne • September 20, 2016 Page 4
FY 2016 Guidance Confirmed at Q2
20152016
Sales€1.5bn Low-to mid-single-digit % increase
EBITDA
before special items
€347m Low-to mid-single-digit % increase
Assuming end Q2 2016 Fx rates (USD 1.11)
Outlook depends on specific planning assumptions
as detailed in the Annual Report
Sales ∆Fx and portfolio adjusted
FY 2016 Guidance Confirmed at Q2
20152016
Sales€1.5bn Low-to mid-single-digit % increase
EBITDA
before special items
€347m Low-to mid-single-digit % increase
Assuming end Q2 2016 Fx rates (USD 1.11)
Outlook depends on specific planning assumptions
as detailed in the Annual Report
Sales ∆Fx and portfolio adjusted
Meet Management in Cologne • September 20, 2016 Page 5
Mid-Term Aspirations 2018
2015Aspiration 2018
Sales
+4.5% to
€1.5bn
4-5% CAGR (2015-2018)
Adj. EBITDA margin23.3%23-24%
Sales ∆ Fx & portf. adjusted, EBITDA before special items
Outlook depends on specific planning assumptions outlined in the Interim Report Q2 2016
Mid-Term Aspirations 2018
2015Aspiration 2018
Sales
+4.5% to
€1.5bn
4-5% CAGR (2015-2018)
Adj. EBITDA margin23.3%23-24%
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, 2016 Page 6
Selected R&D Activities
Focus to
improve:
•Convenience
•Efficacy
•Safety
New
formulations
•Ecto-
parasiticides
•Endo-
parasiticides
•Endecto-
parasiticides
Parasiticides
•Dairy Health
•Respiratory Diseases
Antimicrobials
•Metaphylactic strengthening
of immune
system
•Respiratory
Diseases
Immuno-
stimulation
•Allergy &
Inflammation
•Chronic
Kidney
Disease
Pharmaceutical
Specialties
R&D investment approx. 10% of sales
Selected R&D Activities
Focus to
improve:
•Convenience
•Efficacy
•Safety
New
formulations
•Ecto-
parasiticides
•Endo-
parasiticides
•Endecto-
parasiticides
Parasiticides
•Dairy Health
•Respiratory Diseases
Antimicrobials
•Metaphylactic strengthening
of immune
system
•Respiratory
Diseases
Immuno-
stimulation
•Allergy &
Inflammation
•Chronic
Kidney
Disease
Pharmaceutical
Specialties
R&D investment approx. 10% of sales
Meet Management in Cologne • September 20, 2016 Page 7
Sustained Life Cycle Management Building
on Excellent Brands
Our Animal Health business demonstrated strength in LCM
over the past decades with a number of top selling brands in industry
0
100
200
300
400
500
600
700
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Advantix: + permethrin
Spectrum: + tick / mosquito
Advocate : + moxidectin
Spectrum: + worms
Advantage : imidacloprid Spectrum: fleas / lice
Seresto: imidacloprid / flum. collar
Spectrum: fleas / ticks 8 months duration
Sales (€ million)
* LCM: life cycle management
Advantage
Advantix
Advocate
Seresto
Sustained Life Cycle Management Building
on Excellent Brands
Our Animal Health business demonstrated strength in LCM
over the past decades with a number of top selling brands in industry
0
100
200
300
400
500
600
700
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Advantix: + permethrin
Spectrum: + tick / mosquito
Advocate : + moxidectin
Spectrum: + worms
Advantage : imidacloprid Spectrum: fleas / lice
Seresto: imidacloprid / flum. collar
Spectrum: fleas / ticks 8 months duration
Sales (€ million)
* LCM: life cycle management
Advantage
Advantix
Advocate
Seresto
Meet Management in Cologne • September 20, 2016 Page 8
Seresto–Achieved Animal Health Blockbuster
Status and Continues to Grow
•Seresto showed strong over-
performance in all regions since
launch
•Life-cycle management includes new
claim extension and digital add-ons
2012 2013 2014 20151H’16
+62% 121
113
52
31
9
Highlights
€ million; ∆% yoy Fx adjusted SerestoSales
Seresto–Achieved Animal Health Blockbuster
Status and Continues to Grow
•Seresto showed strong over-
performance in all regions since
launch
•Life-cycle management includes new
claim extension and digital add-ons
2012 2013 2014 20151H’16
+62% 121
113
52
31
9
Highlights
€ million; ∆% yoy Fx adjusted SerestoSales
Meet Management in Cologne • September 20, 2016 Page 9
Advocate –Achieving Robust Growth
More than Ten Years After Launch
201320142015136
149
177
•Advocate brand is a member of the
Advantage family of parasiticides
•Growth due to continuous post marketing
studies supporting new claims
•Strong performance in EU, especially in
UK due to first in category lungworm
claim
+8%
+10%
Highlights
€ million; ∆% yoy Fx adjusted Advocate Sales
Advocate –Achieving Robust Growth
More than Ten Years After Launch
201320142015136
149
177
•Advocate brand is a member of the
Advantage family of parasiticides
•Growth due to continuous post marketing
studies supporting new claims
•Strong performance in EU, especially in
UK due to first in category lungworm
claim
+8%
+10%
Highlights
€ million; ∆% yoy Fx adjusted Advocate Sales
Meet Management in Cologne • September 20, 2016 Page 10
AntiinfectiveHealth Management –Current
Limitations and Potential Solution Limitations at present …
… potential future solution •Not antigen-specific(“one-for many”)
•Potential use in prophylaxis ANDtreatment
•Fast onset of activity
•Prevention:onset of immunity delayed by
weeks, protection limited to selected
antigens
•Treatment:political / public pressure on
antibiotic use (resistance)
Metaphylaxis
(antibiotics play in the category)
Metaphylaxis
(immunostimulation)
Prevention
(vaccines)
Treatment
(antibiotics)
Prevention
(vaccines)
Treatment
(antibiotics)
AntiinfectiveHealth Management –Current
Limitations and Potential Solution Limitations at present …
… potential future solution •Not antigen-specific(“one-for many”)
•Potential use in prophylaxis ANDtreatment
•Fast onset of activity
•Prevention:onset of immunity delayed by
weeks, protection limited to selected
antigens
•Treatment:political / public pressure on
antibiotic use (resistance)
Metaphylaxis
(antibiotics play in the category)
Metaphylaxis
(immunostimulation)
Prevention
(vaccines)
Treatment
(antibiotics)
Prevention
(vaccines)
Treatment
(antibiotics)
Meet Management in Cologne • September 20, 2016 Page 11
Zelnate–Effective Non-Antibiotic Bovine
Respiratory Disease Treatment
•The first immunostimulantthat
effectively aids in the treatment of
BRD*
•Jumpstarts innate immunity
that helps the animal to help
themselves
•Complements existing solutions to
reduce mortality and potential to
reduce need for antibiotic use
•Launched in US in 2015and
Canada in 2016 ZelnateFacts
* BRD: bovine respiratory disease (due to Manheimia haemolytica)
Zelnate–Effective Non-Antibiotic Bovine
Respiratory Disease Treatment
•The first immunostimulantthat
effectively aids in the treatment of
BRD*
•Jumpstarts innate immunity
that helps the animal to help
themselves
•Complements existing solutions to
reduce mortality and potential to
reduce need for antibiotic use
•Launched in US in 2015and
Canada in 2016 ZelnateFacts
* BRD: bovine respiratory disease (due to Manheimia haemolytica)
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