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Investor
Conference Call
Q1 2023
/ / / / / / / / / / / / / / / /
May 11th, 2023
Cautionary Statements Regarding Forward-Looking Information
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
2
WWW.BAYER.COM
This presentation may contain forward-looking
statements based on current assumptions
and forecasts made by Bayer management.
Various known and unknown risks, uncertainties
and other factors could lead to material
differences between the actual future results,
financial situation, development or performance
of the company and the estimates given here.
These factors include those discussed in
Bayer’s public reports which are available
on the Bayer website.
The company assumes no
liability whatsoever to update
these forward-looking
statements or to conform
them to future events or
developments.
Werner Baumann, CEO
CEO Remarks
Slow Start – Outlook Confirmed
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
4
1Solid Underlying Growth
Earnings at Lower End of Range
3
2 Glyphosate Dynamics Key Variable
Wolfgang Nickl, CFO
Results & Outlook
Group Performance Q1 2023
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
6
Minor currency
tailwind of €102m
14.639
14.389
Q1'22 Q1'23
NET SALES
EBITDA Margin before special items, cpa = currency and portfolio adjusted
in m€,
before special items
EBITDA FREE CASH FLOW
3,53
2,95
Q1'22 Q1'23
in €, Cont. Operations
CORE EPS
Impacted by inflation
Lower divisional
contributions; better
core financial result
in m€
in m€, ∆% yoy
-2%
(-1% cpa)
-16%
5.251
4.471
Q1'22 Q1'23
-15%
31.1%
35.9%
%
-1.187
-4.102
Q1'22 Q1'23
Including PCB
settlement payouts
Faster glyphosate normalization nearly offset by strong growth of
8% in remaining portfolio
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
7
3.669
3.267
Q1'22 Q1'23
43.4% 39.1%
Volume
-8%
Currency
+2%
Price
+7%
Portfolio
-2%
Sales growth rates in Key Messages cpa = currency and portfolio adjusted
Net Sales
m€, ∆% yoy
EBITDA
m€, before special items
EBITDA Margin before special items
-11%
-1%
(-1% cpa)
Crop Science
Q1 2023
-688
(-50%)
+592
(+8%)
Decline in Glyphosate-based
herbicides and cost inflation
weigh on earnings
Soy S&T (+1%) with volume
gains in LATAM
~€700m decline in glyphosate-based herbicides (GLY) almost
compensated by remaining portfolio (+8%)
Higher pricing drives Corn S&T
(+16%) and Insecticides (+13%) Strong pricing across
remaining portfolio partly
compensate downsides
Strong pricing in Fungicides offset by lower volumes
8,447 8,351
Launch assets continue to perform well, headwinds in China
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
8
Net Sales
m€, ∆% yoy
EBITDA
m€, before special items
Volume
-2%
Currency
-1%
Price
-1%
Portfolio
-1%
1.389
1.106
Q1'22 Q1'23
EBITDA Margin before special items
30.0% 25.1%
4.624 4.407
Q1'22 Q1'23
Sales growth rates in Key Messages cpa = currency and portfolio adjusted
-20%
-5%
(-3% cpa)
Sales shortfall, changes in
product mix and inflation
weigh on gross margin
Eylea (+5%) with higher
volumes across regions
China impacted by COVID dynamics across the portfolio incl. Xarelto,
in addition to VBP pressure on Adalat
Nubeqa (+131%) and Kerendia (+362%)
continue strong growth, Kerendia entering
Top 15 Pharma products
Ongoing growth investments
in R&D, asundexian PIII
recruitment accelerating
Pharmaceuticals
Q1 2023
Radiology (+9%) benefiting from volume growth and healthy pricing
Continued growth, Nutritionals normalize at high level
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
9
Net Sales
m€, ∆% yoy
EBITDA
m€, before special items
Volume
-4%
Currency
0%
Price
+8%
Portfolio
0%
Continued investments into
innovation
Cough & Cold (+16%) driven by
still elevated cold & flu incidences
Allergy (+16%) on top of
strong prior year and with major
contribution from Astepro
388 379
Q1'22 Q1'23
25.7% 24.1%
EBITDA Margin before special items
-2%
Bepanthen continuing to
support Dermatology (+10%)
1.512 1.573
Q1'22 Q1'23
+4%
(+4% cpa)
Nutritionals (-10%) facing temporary
supply constraints and strong prior year
Operational productivity
programs and active pricing
compensate cost inflation
Sales growth rates in Key Messages cpa = currency and portfolio adjusted
Consumer Health
Q1 2023
Updated Divisional Outlook Full Year 2023
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
10
~ +3% ~ +1.5% ~25%
~ +1% ~ +1% > 29%
~ +5% ~ +5% ~ 23%
Crop Science
Pharmaceuticals
Consumer Health
1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted
EBITDA Margin
before special items 1
Sales Growth
revised May, cpa 1
Sales Growth
as of Feb, cpa 1
Group P&L Outlook confirmed towards lower end of range
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
11
in €
Net Sales 51bn – 52bn
EBITDA
(before special items)
12.5bn – 13bn
Core EPS 7.20 – 7.40
Free Cash Flow ~ 3bn
Net Financial Debt 32bn – 33bn
• Representing sales growth of 2% to 3% cpa
• Including portfolio effects of -€500m in sales
• FX headwinds of ~€1.7bn estimated for sales 2
• Price pressure and inflation to be partially
compensated by higher volumes, active pricing
management and cost savings
• Including expected settlement payouts of €2-3bn
• Net Financial Debt expected towards upper end
FY 2023 OUTLOOK
at constant currencies 1
Key Assumptions
1 Reflects our 2023 plan at the average actual currencies for 2022
2 Currency assumptions based on month-end March 2023 spot rates (1 EUR=) 1.09 USD, 5.54 BRL, 7.47 CNY.
Impact is calculated as difference to constant currencies.
Back Up
Q1 2023
/ / / / / / / / / / / / / / / /
May 11th, 2023
FY 2023: Group Other KPIs (as of Feb. 2023)
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
13
Special Items
(EBITDA)
~ - €1.0bn
Core Depreciation ~ - €1.6bn
Core Financial Result ~ - €1.9bn
Core Tax Rate ~ 23%
Reconciliation
(cEBITDA)
- €0.7bn to
- €0.8bn
• Special items (EBITDA) primarily driven by
ongoing restructuring programs
• Core depreciation: Formerly guided for “as
depreciation and amortization (clean)”
(2023e: - €4.0bn) and “of which for intangible
assets (clean) (2023e: - €2.4bn)“
• Reconciliation (cEBITDA) includes the catch ups
in long-term incentive provisions based on
estimated share price of €60 at year-end 2023
FY 2023 OUTLOOK
at constant currencies1
Key Assumptions
1 Reflects our 2023 plan at the average actual currencies for 2022
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
14
Sales
• Portfolio ex. glyphosate expected to grow by ~10%, or ~€2.0bn: Expect double-digit percent sales increases in corn S&T, fungicides,
insecticides, supported by higher prices from continued innovation and strong farm incomes. Anticipating share and volume gains in corn
S&T from higher planted acres and volume gains in fungicides and insecticides, particularly in Q4 in LATAM.
• Glyphosate-based herbicide sales expected to decline by -30% to -35%, or ~€1.7bn at the midpoint: Anticipating continued
normalization of pricing as a result of improving supply, partially offset by higher sales volumes
EBITDA
• Stronger pricing (ex. glyphosate) and >€500m cost saving measures to partially offset incremental inflation (~4% of sales) and declines in
glyphosate-based herbicide sales
Accelerating Growth Excluding Glyphosate (updated May 2023)
1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted, not incl. portfolio effect of ~ -€380m in net sales
Key Assumptions
Sales Growth 1
(cpa)
EBITDA Margin 1
(before special items)
Crop Science
FY Outlook
(revised May 2023)
~ +1.5% ~25%
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
15
New Products to Offset Declines in Mature Portfolio (as of Feb. 2023)
Key Assumptions
Sales Growth 1
(cpa)
EBITDA Margin 1
(before special items)
Pharmaceuticals
FY Outlook
(Feb. 2023)
~ +1% > 29%
Sales
• Accelerated growth from Nubeqa and Kerendia to exceed €1bn, Eylea expected to offset increasing price pressure through higher volumes
• Xarelto to decline mid-single digit driven by ongoing pricing headwinds and patent expiries in various smaller markets
• Volume-based procurement in China to lower Adalat sales by ~50%
• HY1 to be significantly below HY2 in top and bottom line
EBITDA
• Stringent OPEX management and execution of ongoing transformation program; focused R&D investment and reallocation of spend
towards launch assets
1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted, not incl. portfolio effect of ~ -€140m in net sales
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
16
Key Assumptions
Sales Growth 1
(cpa)
EBITDA Margin 1
(before special items)
Consumer Health
FY Outlook
(Feb. 2023)
~ +5% ~ 23%
Sales
• Executing on our mid-term ambitions, innovation and the value of our brands will drive outperformance vs. market
• Supply constraints and price elasticity also expected to continue, leading to market growth expectation of 3% - 5% p.a.
• Expecting softer development in HY1 due to challenging macroeconomic environment and strong prior year comparable
EBITDA
• Overcompensating cost pressures by firmly executing on ongoing comprehensive cost productivity program
• Strong focus on optimizing gross margin, enhancing digital capabilities and lifting SG&A efficiencies
1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted
Above-Market Growth and Margin Expansion in a Challenging
Environment (as of Feb. 2023)
Q1 2023: Core EPS to EPS Bridge
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
17
in €
Q1 2023: Summary
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
18
3
1 Operating cash flow, cont. less cash flow relevant CAPEX and Leasing; 2 Depreciation and extraordinary amortization PPE
[€ million, if not specified] Q1 22 Q1 23 Q1 22 Q1 23 Q1 22 Q1 23 Q1 22 Q1 23 Q1 22 Q1 23
Sales 8,447 8,351 4,624 4,407 1,512 1,573 56 58 14,639 14,389
Sales by region:
Europe / Middle East / Africa 2,133 2,297 1,835 1,771 491 516 55 55 4,514 4,639
North America 4,361 4,182 1,020 1,110 581 612 0 2 5,962 5,906
Asia / Pacific 624 632 1,535 1,305 252 244 0 0 2,411 2,181
Latin America 1,329 1,240 234 221 188 201 1 1 1,752 1,663
EBITDA 3,715 3,249 1,437 1,064 370 373 -230 -368 5,292 4,318
Special items 46 -18 48 -42 -18 -6 -35 -87 41 -153
EBITDAbefore special items 3,669 3,267 1,389 1,106 388 379 -195 -281 5,251 4,471
EBITDA margin before special items [%] 43.4% 39.1% 30.0% 25.1% 25.7% 24.1% -348.2% -484.5% 35.9% 31.1%
EBIT 3,028 2,319 1,202 806 284 282 -302 -434 4,212 2,973
Special items 45 -296 48 -42 -18 -6 -35 -87 40 -431
EBIT before special items 2,983 2,615 1,154 848 302 288 -267 -347 4,172 3,404
EBIT margin before special items [%] 35.3% 31.3% 25.0% 19.2% 20.0% 18.3% -476.8% -598.3% 28.5% 23.7%
Operating cash flow, continuing -2,387 -3,364 1,024 707 313 183 324 -1,076 -726 -3,550
Free operating cash flow1
-2,577 -3,623 875 480 285 158 342 -1,031 -1,866 -4,874
Free cash flow -1,187 -4,102
EBITDAbefore special items 5,251 4,471
Core depreciation2
-374 -395
Core EBIT 4,877 4,076
Core financial result -419 -275
Core taxes & minorities -989 -900
Core tax rate 22.1% 23.6%
Core Net Income 3,469 2,901
No. of shares [million] 982.42 982.42
Core EPS [€] 3.53 2.95
Crop Science Pharmaceuticals Consumer Health Reconciliation Group
Back Up
Innovation
Q1 2023
/ / / / / / / / / / / / / / / /
May 11th, 2023
Phase I Phase II Phase III
CORN
SEED
&
TRAIT
SOYBEAN
SEED
&
TRAIT
Seed Placement Digital Tool – NA 3rd Generation Insect Protection
2nd Generation Soy Cyst Nematode resistance
Digital Disease Mgmt. - NA
4th Generation Herbicide Tolerance (HT4)
(Adds 2, 4-D and HPPD tolerance)
5th Generation Herbicide Tolerance
(Adds PPO tolerance )
VEGETABLES
and
OTHER
4
Including
Carbon
Model
Short Stature Corn – Biotech Trait3
5th Generation Herbicide Tolerance w/ (RHS2)
5th Generation Lepidoptera Protection
4th Generation Coleoptera Protection
Seed Placement Digital Tool - NA
Corn Disease Shield - NA
2 In collaboration with KWS; 3 In collaboration with BASF; 4 “Other” category includes seeds and traits, such as cotton, canola, wheat, OSR, rice, vegetable seeds and sugarbeets, plus carbon and digital Models
Phase IV
PSP = Peak Sales Potential, 50% incremental; Expected to reach 30% of PSP by 2032, 80% of PSP by 2037 and remainder in 2038+; Note that products are excluded from the pipeline PSP typically the year following launch
Canola/OSR Digital Disease Mgmt. - NA Wheat Digital Disease Mgmt. - EMEA
Cotton 4th Generation Insect Protection
Canola Dicamba Tolerance
Sugarbeets 2nd Generation Herbicide
Tolerance2
Lygus and Thrips Control
(ThryvOn Technology) -
Stewarded Commercial Launch
Cotton 4th Generation Herbicide
Tolerance (HT4)
(5 tolerances – Adds 2, HPPD and PPO)
4th Generation Insect Protection
Digital Disease Mgmt. – NA
Wheat Annual Germplasm Upgrades
Cotton Annual Germplasm Upgrades
Canola/OSR Annual Germplasm Upgrades
Rice Annual Germplasm Upgrades
Wheat Disease Package Upgrades
Veg- Annual Germplasm Upgrades
advanced to next phase
Projects listed here and included in the peak sales potential by segment do not include projects funded by our LEAPS investments; includes all advancements made in FY’22, updated Feb’23
Short Stature Corn – Breeding Approach
4th Generation Lepidoptera Protection
Seed Density Digital Tool – EMEA
Seed Density Digital Tool – LATAM
2nd Generation Seed Density
Digital Tool - NA
Vistive Gold Xtend
Trait
Annual Germplasm Upgrades
Annual Germplasm Upgrades
Soybean Native Resistance
Digital Model
Breeding
~€11bn
~€4bn
~€6bn
PSP
Annual Germplasm Upgrades
Soybean Native Resistance Soybean Native Resistance Soybean Native Resistance
Annual Germplasm Upgrades
Annual Germplasm Upgrades
Annual Germplasm Upgrades Annual Germplasm Upgrades Annual Germplasm Upgrades
Wheat Annual Germplasm Upgrades
Cotton Annual Germplasm Upgrades
Canola/OSR Annual Germplasm Upgrades
Rice Annual Germplasm Upgrades
Wheat Disease Package Upgrades
Veg- Annual Germplasm Upgrades
Wheat Annual Germplasm Upgrades
Cotton Annual Germplasm Upgrades
Canola/OSR Annual Germplasm Upgrades
Rice Annual Germplasm Upgrades
Wheat Disease Package Upgrades
Veg- Annual Germplasm Upgrades
Wheat Annual Germplasm Upgrades
Cotton Annual Germplasm Upgrades
Canola/OSR Annual Germplasm Upgrades
Rice Annual Germplasm Upgrades
Wheat Disease Package Upgrades
Veg- Annual Germplasm Upgrades
€21bn
PSP
Crop Science: Seed & Traits and Digital R&D Pipeline (Annual Update Feb 2023)
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
20
Luna Flexx
Super Nativo
Delaro Forte
Vayego Duo
Velum LCM
Rice Plant Hopper
Life Cycle Management1
1 Shown here is a subset of Bayer’s total life cycle management activities; focused on new formulation developments which have the potential to bring significant innovation to customers compared to currently marketed product; Products shown may not yet be fully registered
in all jurisdictions; includes all advancements made in FY’22, updated Feb’23; 2 SeedGrowth is currently reported within other SBEs; 3 3rd party collaboration
PSP = Peak Sales Potential, 50% incremental; Expected to reach 30% of PSP by 2032, 80% of PSP by 2037 and remainder in 2038+; Note that products are excluded from the pipeline PSP typically the year following launch.
Non-Selective
Selective
Glyphosate LCM
Merlin Flexx / Adengo LCM
advanced to next phase
HERBICIDES
FUNGIC.
INSECT.
SEED
GROWTH
2
Phase II Phase III
New AI Development
New Herbicide
New Herbicide
New Herbicide
New Fungicide New Fungicide
Novel Mite Solution Plenexos
Cereals, oilseed rape, sugarbeets, cotton and rice
Fruits and vegetables
Soybeans
Corn
Phase IV
New Herbicide
New Seed Treatment
Balance Flexx LCM
Convintro
Mateno Complete
Council Family
Ronstar One
Mesosulfuron LCM
INS FUN ready mixture
Redigo FS 25
Selection of projects listed here and included in the peak sales potential by segment do not include projects in early research or discovery
New Insecticide
New Herbicide
New Fungicide3
New Seed Treatment
New Herbicide3
Biological Small Molecule
Phase I
~€4bn
PSP
~€3bn
~€2bn
New over-the-top herbicide
€9bn
PSP
Crop Science: Crop Protection R&D Pipeline (Annual Update Feb 2023)
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
21
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
22
Global sales development (€m, cpa growth rates)
Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023
US
ex-US
1 Source: IQVIA, Jan 2023 2 mHSPC: metastatic hormone sensitive prostate cancer 3 nmCRPC: non-metastatic castration resistant prostate cancer 4 ARI: Androgen Receptor Inhibitor
178
76
106
127
158
Key sales drivers
Q1 2023:
US continues to be key growth driver, driven by mHSPC2
launch and ongoing nmCRPC3 gains
Nubeqa now at #2 in 2nd generation ARIs4 for non-
metastatic patients, set to become #2 in metastatic
patients in its indications
Additional approvals and strong launch momentum also
drive sales dynamics in non-US regions
Overall, Nubeqa approved in more than 80 countries
(mHSPC approvals in 47 markets)
US launch performance (monthly NBRx)1
-
100
200
300
400
500
600
700
800
Aug-22:
mHSPC approval
Pharmaceuticals: Nubeqa sales more than doubled again in Q1,
continuing to gain market share
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
23
Pharmaceuticals: Kerendia continues strong launch momentum
since initial US launch in Aug 2021
Global sales development (€m, cpa growth rates)
Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023
US
ex-US
Q1 2023:
Continued US market uptake
Significant growth in NBRx compared to
Q1 2022 (>90%)
Broad utility and relevance across GPs and
specialists
China: NRDL Listing starting March 2023
EU label extension reflecting results from Phase III study
FIGARO-DKD
Potential for further inclusion in treatment guidelines
1 Source: IQVIA, National NBRx, March 31, 2023
US launch performance (monthly NBRx)1
11
20
29
48
Key sales drivers
52
0
2.000
4.000
6.000
8.000
10.000
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
24
11
Additions Discontinuations
Newsflow Advancements
Phase I Phase II Phase III Commercial
Initiation of LGMD2i Gene
Therapy (LION-101)
Discontinuation of BDKRB1
Receptor Antagonist
Discontinuation of P2X4
Antagonist
Discontinuation of BDKRB1
Receptor Antagonist
Neuropathic Pain (BRADiNP)
Discontinuation of
Runcaciguat (sGC Activator)
CKD
Darolutamide (AR Inhibitor) /
Prostate Cancer with
Biochemical Recurrence after
Curative Radiotherapy
(ARASTEP)
Nubeqa (Darolutamide)
 Approval in mHSPC in
Europe, Japan and in China
Eylea
 EU and Japan submission
of 8mg aflibercept (DME,
nAMD)
Oncology
Cardiovascular Diseases
Immunology & Inflammation
Others
Neurology / Rare Diseases
Pharmaceuticals: R&D Developments (since last update on Feb 15, 2023)
Bayer Q1 2023 Investor Conference Call /// May 11th, 2023
25
Full pipeline package available for download under:
https://www.bayer.com/en/pharma/development-pipeline
Pharmaceuticals: Pipeline Overview1 (as of Apr 26, 2023)
Phase I
Elimusertib (ATR Inhibitor) (BAY 1895344)
AhR Inhibitor (BAY 2416964)
mEGFR Inhibitor (BAY 2927088)
DGKzeta Inhibitor (BAY 2965501)
CCR8 Ab (BAY 3375968)
Congestive Heart Failure Gene Therapy (AB-1002
formerly NAN-101)
sGC Activator Oral (BAY 3283142)
Anti-a2AP (BAY 3018250)
sGC Activator Inhale (BAY 1211163)
Bemdaneprocel (Parkinson’s Disease Cell Therapy)
(BRT-DA01)
Parkinson‘s Disease Gene Therapy
(AB-1005 formerly AAV2-GDNF-PD)
Multiple System Atrophy Gene Therapy
(AB-1005 formerly AAV2-GDNF-MSA)
Pompe Disease Gene Therapy (ACTUS-101)
Huntington‘s Disease Gene Therapy (BV-101)
LGMD2i Gene Therapy (LION-101)
GPR84 Antagonist (BAY 3178275)
* Including Precision Cardiovascular, Nephrology & Acute Care
1 Bayer and partner sponsored + 3rd party label enabling studies with first patient first visit 2 Pre-clinical selected assets on path to IND 3 Conducted by Merck & Co 4 US submission made by Regeneron
Life cycle management
New molecular entity
Phase 02
DGKalpha Inh (BAY 2862789)
PSMA TAC (BAY 3546828)
PSMA SMOL TAC (BAY 3563254)
VVD Keap1 Act (BAY 3605349)
VVD STAT3 Inh (BAY 3630914)
SEMA 3a (BAY 3401016)
Anti-coagulant (BAY 3389934)
Next Generation Liver MRI
(BAY 3393081)
Phase II
Regorafenib (combi Nivolumab) (BAY 734506)
Solid tumors (recurrent or metastatic)
Asundexian (FXIa Inhibitor) (BAY 2433334)
Major Adverse Cardiac Events Prevention (PACIFIC-AMI)
Adrenomedullin Pegol (PEG-ADM) (BAY 1097761)
Acute Resp. Distress Syn. (ARDS) (SEAL)
Zabedosertib (IRAK4 Inh.) (BAY 1834845)
Atopic Dermatitis (DAMASK)
Gadoquatrane (High Relaxivity Contrast Agent)
(BAY 1747846)
Magnetic Resonance Imaging (HRCA-PAT)
Runcaciguat (sGC Activator) (BAY 1101042)
Non-prolif. Diabetic Retinopathy (NPDR) (NEON-NPDR)
Phase III
Copanlisib (PI3K Inhibitor)
Non-Hodgkin Lymphoma (CHRONOS-4)
Darolutamide (AR Inhibitor)
Prostate Cancer (mHSPC) (ARANOTE)
Adjuvant Prostate Cancer (DASL-HiCaP)
Prostate cancer with biochemical recurrence after curative radiotherapy
(ARASTEP)
Finerenone (MR Antagonist)
Heart Failure (HFmr/pEF) (FINEARTS-HF)
Non-diabetic CKD (FIND-CKD)
Vericiguat (sGC Stimulator)
Heart Failure (HFrEF) (VICTOR3)
Asundexian (FXIa Inhibitor)
Stroke Prevention in Atrial Fibrillation (OCEANIC-AF)
2⁰ Stroke Prevention (OCEANIC-STROKE)
Elinzanetant (Neurokinin-1,3 Rec Antagonist)
Vasomotor Symptoms (OASIS)
Biologic
Antibody Cell Therapy Contrast Agent Gene Therapy Radiotherapy Small Molecule
Submissions
Aflibercept 8MG
EU, JP, US4: Diabetic Macular Edema (DME)
EU, JP, US4: Neovasc. Age-rel. Macular Degen. (nAMD)
Oncology
Cardiovascular*
Neurology / Rare Diseases
Immunology & Inflammation
Others
Q1 2023 Investor Conference Call Presentation

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Q1 2023 Investor Conference Call Presentation

  • 1. Investor Conference Call Q1 2023 / / / / / / / / / / / / / / / / May 11th, 2023
  • 2. Cautionary Statements Regarding Forward-Looking Information Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 2 WWW.BAYER.COM This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
  • 4. Slow Start – Outlook Confirmed Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 4 1Solid Underlying Growth Earnings at Lower End of Range 3 2 Glyphosate Dynamics Key Variable
  • 6. Group Performance Q1 2023 Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 6 Minor currency tailwind of €102m 14.639 14.389 Q1'22 Q1'23 NET SALES EBITDA Margin before special items, cpa = currency and portfolio adjusted in m€, before special items EBITDA FREE CASH FLOW 3,53 2,95 Q1'22 Q1'23 in €, Cont. Operations CORE EPS Impacted by inflation Lower divisional contributions; better core financial result in m€ in m€, ∆% yoy -2% (-1% cpa) -16% 5.251 4.471 Q1'22 Q1'23 -15% 31.1% 35.9% % -1.187 -4.102 Q1'22 Q1'23 Including PCB settlement payouts
  • 7. Faster glyphosate normalization nearly offset by strong growth of 8% in remaining portfolio Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 7 3.669 3.267 Q1'22 Q1'23 43.4% 39.1% Volume -8% Currency +2% Price +7% Portfolio -2% Sales growth rates in Key Messages cpa = currency and portfolio adjusted Net Sales m€, ∆% yoy EBITDA m€, before special items EBITDA Margin before special items -11% -1% (-1% cpa) Crop Science Q1 2023 -688 (-50%) +592 (+8%) Decline in Glyphosate-based herbicides and cost inflation weigh on earnings Soy S&T (+1%) with volume gains in LATAM ~€700m decline in glyphosate-based herbicides (GLY) almost compensated by remaining portfolio (+8%) Higher pricing drives Corn S&T (+16%) and Insecticides (+13%) Strong pricing across remaining portfolio partly compensate downsides Strong pricing in Fungicides offset by lower volumes 8,447 8,351
  • 8. Launch assets continue to perform well, headwinds in China Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 8 Net Sales m€, ∆% yoy EBITDA m€, before special items Volume -2% Currency -1% Price -1% Portfolio -1% 1.389 1.106 Q1'22 Q1'23 EBITDA Margin before special items 30.0% 25.1% 4.624 4.407 Q1'22 Q1'23 Sales growth rates in Key Messages cpa = currency and portfolio adjusted -20% -5% (-3% cpa) Sales shortfall, changes in product mix and inflation weigh on gross margin Eylea (+5%) with higher volumes across regions China impacted by COVID dynamics across the portfolio incl. Xarelto, in addition to VBP pressure on Adalat Nubeqa (+131%) and Kerendia (+362%) continue strong growth, Kerendia entering Top 15 Pharma products Ongoing growth investments in R&D, asundexian PIII recruitment accelerating Pharmaceuticals Q1 2023 Radiology (+9%) benefiting from volume growth and healthy pricing
  • 9. Continued growth, Nutritionals normalize at high level Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 9 Net Sales m€, ∆% yoy EBITDA m€, before special items Volume -4% Currency 0% Price +8% Portfolio 0% Continued investments into innovation Cough & Cold (+16%) driven by still elevated cold & flu incidences Allergy (+16%) on top of strong prior year and with major contribution from Astepro 388 379 Q1'22 Q1'23 25.7% 24.1% EBITDA Margin before special items -2% Bepanthen continuing to support Dermatology (+10%) 1.512 1.573 Q1'22 Q1'23 +4% (+4% cpa) Nutritionals (-10%) facing temporary supply constraints and strong prior year Operational productivity programs and active pricing compensate cost inflation Sales growth rates in Key Messages cpa = currency and portfolio adjusted Consumer Health Q1 2023
  • 10. Updated Divisional Outlook Full Year 2023 Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 10 ~ +3% ~ +1.5% ~25% ~ +1% ~ +1% > 29% ~ +5% ~ +5% ~ 23% Crop Science Pharmaceuticals Consumer Health 1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted EBITDA Margin before special items 1 Sales Growth revised May, cpa 1 Sales Growth as of Feb, cpa 1
  • 11. Group P&L Outlook confirmed towards lower end of range Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 11 in € Net Sales 51bn – 52bn EBITDA (before special items) 12.5bn – 13bn Core EPS 7.20 – 7.40 Free Cash Flow ~ 3bn Net Financial Debt 32bn – 33bn • Representing sales growth of 2% to 3% cpa • Including portfolio effects of -€500m in sales • FX headwinds of ~€1.7bn estimated for sales 2 • Price pressure and inflation to be partially compensated by higher volumes, active pricing management and cost savings • Including expected settlement payouts of €2-3bn • Net Financial Debt expected towards upper end FY 2023 OUTLOOK at constant currencies 1 Key Assumptions 1 Reflects our 2023 plan at the average actual currencies for 2022 2 Currency assumptions based on month-end March 2023 spot rates (1 EUR=) 1.09 USD, 5.54 BRL, 7.47 CNY. Impact is calculated as difference to constant currencies.
  • 12. Back Up Q1 2023 / / / / / / / / / / / / / / / / May 11th, 2023
  • 13. FY 2023: Group Other KPIs (as of Feb. 2023) Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 13 Special Items (EBITDA) ~ - €1.0bn Core Depreciation ~ - €1.6bn Core Financial Result ~ - €1.9bn Core Tax Rate ~ 23% Reconciliation (cEBITDA) - €0.7bn to - €0.8bn • Special items (EBITDA) primarily driven by ongoing restructuring programs • Core depreciation: Formerly guided for “as depreciation and amortization (clean)” (2023e: - €4.0bn) and “of which for intangible assets (clean) (2023e: - €2.4bn)“ • Reconciliation (cEBITDA) includes the catch ups in long-term incentive provisions based on estimated share price of €60 at year-end 2023 FY 2023 OUTLOOK at constant currencies1 Key Assumptions 1 Reflects our 2023 plan at the average actual currencies for 2022
  • 14. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 14 Sales • Portfolio ex. glyphosate expected to grow by ~10%, or ~€2.0bn: Expect double-digit percent sales increases in corn S&T, fungicides, insecticides, supported by higher prices from continued innovation and strong farm incomes. Anticipating share and volume gains in corn S&T from higher planted acres and volume gains in fungicides and insecticides, particularly in Q4 in LATAM. • Glyphosate-based herbicide sales expected to decline by -30% to -35%, or ~€1.7bn at the midpoint: Anticipating continued normalization of pricing as a result of improving supply, partially offset by higher sales volumes EBITDA • Stronger pricing (ex. glyphosate) and >€500m cost saving measures to partially offset incremental inflation (~4% of sales) and declines in glyphosate-based herbicide sales Accelerating Growth Excluding Glyphosate (updated May 2023) 1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted, not incl. portfolio effect of ~ -€380m in net sales Key Assumptions Sales Growth 1 (cpa) EBITDA Margin 1 (before special items) Crop Science FY Outlook (revised May 2023) ~ +1.5% ~25%
  • 15. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 15 New Products to Offset Declines in Mature Portfolio (as of Feb. 2023) Key Assumptions Sales Growth 1 (cpa) EBITDA Margin 1 (before special items) Pharmaceuticals FY Outlook (Feb. 2023) ~ +1% > 29% Sales • Accelerated growth from Nubeqa and Kerendia to exceed €1bn, Eylea expected to offset increasing price pressure through higher volumes • Xarelto to decline mid-single digit driven by ongoing pricing headwinds and patent expiries in various smaller markets • Volume-based procurement in China to lower Adalat sales by ~50% • HY1 to be significantly below HY2 in top and bottom line EBITDA • Stringent OPEX management and execution of ongoing transformation program; focused R&D investment and reallocation of spend towards launch assets 1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted, not incl. portfolio effect of ~ -€140m in net sales
  • 16. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 16 Key Assumptions Sales Growth 1 (cpa) EBITDA Margin 1 (before special items) Consumer Health FY Outlook (Feb. 2023) ~ +5% ~ 23% Sales • Executing on our mid-term ambitions, innovation and the value of our brands will drive outperformance vs. market • Supply constraints and price elasticity also expected to continue, leading to market growth expectation of 3% - 5% p.a. • Expecting softer development in HY1 due to challenging macroeconomic environment and strong prior year comparable EBITDA • Overcompensating cost pressures by firmly executing on ongoing comprehensive cost productivity program • Strong focus on optimizing gross margin, enhancing digital capabilities and lifting SG&A efficiencies 1 Reflects our 2023 plan at the average actual currencies for 2022; cpa: currency and portfolio adjusted Above-Market Growth and Margin Expansion in a Challenging Environment (as of Feb. 2023)
  • 17. Q1 2023: Core EPS to EPS Bridge Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 17 in €
  • 18. Q1 2023: Summary Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 18 3 1 Operating cash flow, cont. less cash flow relevant CAPEX and Leasing; 2 Depreciation and extraordinary amortization PPE [€ million, if not specified] Q1 22 Q1 23 Q1 22 Q1 23 Q1 22 Q1 23 Q1 22 Q1 23 Q1 22 Q1 23 Sales 8,447 8,351 4,624 4,407 1,512 1,573 56 58 14,639 14,389 Sales by region: Europe / Middle East / Africa 2,133 2,297 1,835 1,771 491 516 55 55 4,514 4,639 North America 4,361 4,182 1,020 1,110 581 612 0 2 5,962 5,906 Asia / Pacific 624 632 1,535 1,305 252 244 0 0 2,411 2,181 Latin America 1,329 1,240 234 221 188 201 1 1 1,752 1,663 EBITDA 3,715 3,249 1,437 1,064 370 373 -230 -368 5,292 4,318 Special items 46 -18 48 -42 -18 -6 -35 -87 41 -153 EBITDAbefore special items 3,669 3,267 1,389 1,106 388 379 -195 -281 5,251 4,471 EBITDA margin before special items [%] 43.4% 39.1% 30.0% 25.1% 25.7% 24.1% -348.2% -484.5% 35.9% 31.1% EBIT 3,028 2,319 1,202 806 284 282 -302 -434 4,212 2,973 Special items 45 -296 48 -42 -18 -6 -35 -87 40 -431 EBIT before special items 2,983 2,615 1,154 848 302 288 -267 -347 4,172 3,404 EBIT margin before special items [%] 35.3% 31.3% 25.0% 19.2% 20.0% 18.3% -476.8% -598.3% 28.5% 23.7% Operating cash flow, continuing -2,387 -3,364 1,024 707 313 183 324 -1,076 -726 -3,550 Free operating cash flow1 -2,577 -3,623 875 480 285 158 342 -1,031 -1,866 -4,874 Free cash flow -1,187 -4,102 EBITDAbefore special items 5,251 4,471 Core depreciation2 -374 -395 Core EBIT 4,877 4,076 Core financial result -419 -275 Core taxes & minorities -989 -900 Core tax rate 22.1% 23.6% Core Net Income 3,469 2,901 No. of shares [million] 982.42 982.42 Core EPS [€] 3.53 2.95 Crop Science Pharmaceuticals Consumer Health Reconciliation Group
  • 19. Back Up Innovation Q1 2023 / / / / / / / / / / / / / / / / May 11th, 2023
  • 20. Phase I Phase II Phase III CORN SEED & TRAIT SOYBEAN SEED & TRAIT Seed Placement Digital Tool – NA 3rd Generation Insect Protection 2nd Generation Soy Cyst Nematode resistance Digital Disease Mgmt. - NA 4th Generation Herbicide Tolerance (HT4) (Adds 2, 4-D and HPPD tolerance) 5th Generation Herbicide Tolerance (Adds PPO tolerance ) VEGETABLES and OTHER 4 Including Carbon Model Short Stature Corn – Biotech Trait3 5th Generation Herbicide Tolerance w/ (RHS2) 5th Generation Lepidoptera Protection 4th Generation Coleoptera Protection Seed Placement Digital Tool - NA Corn Disease Shield - NA 2 In collaboration with KWS; 3 In collaboration with BASF; 4 “Other” category includes seeds and traits, such as cotton, canola, wheat, OSR, rice, vegetable seeds and sugarbeets, plus carbon and digital Models Phase IV PSP = Peak Sales Potential, 50% incremental; Expected to reach 30% of PSP by 2032, 80% of PSP by 2037 and remainder in 2038+; Note that products are excluded from the pipeline PSP typically the year following launch Canola/OSR Digital Disease Mgmt. - NA Wheat Digital Disease Mgmt. - EMEA Cotton 4th Generation Insect Protection Canola Dicamba Tolerance Sugarbeets 2nd Generation Herbicide Tolerance2 Lygus and Thrips Control (ThryvOn Technology) - Stewarded Commercial Launch Cotton 4th Generation Herbicide Tolerance (HT4) (5 tolerances – Adds 2, HPPD and PPO) 4th Generation Insect Protection Digital Disease Mgmt. – NA Wheat Annual Germplasm Upgrades Cotton Annual Germplasm Upgrades Canola/OSR Annual Germplasm Upgrades Rice Annual Germplasm Upgrades Wheat Disease Package Upgrades Veg- Annual Germplasm Upgrades advanced to next phase Projects listed here and included in the peak sales potential by segment do not include projects funded by our LEAPS investments; includes all advancements made in FY’22, updated Feb’23 Short Stature Corn – Breeding Approach 4th Generation Lepidoptera Protection Seed Density Digital Tool – EMEA Seed Density Digital Tool – LATAM 2nd Generation Seed Density Digital Tool - NA Vistive Gold Xtend Trait Annual Germplasm Upgrades Annual Germplasm Upgrades Soybean Native Resistance Digital Model Breeding ~€11bn ~€4bn ~€6bn PSP Annual Germplasm Upgrades Soybean Native Resistance Soybean Native Resistance Soybean Native Resistance Annual Germplasm Upgrades Annual Germplasm Upgrades Annual Germplasm Upgrades Annual Germplasm Upgrades Annual Germplasm Upgrades Wheat Annual Germplasm Upgrades Cotton Annual Germplasm Upgrades Canola/OSR Annual Germplasm Upgrades Rice Annual Germplasm Upgrades Wheat Disease Package Upgrades Veg- Annual Germplasm Upgrades Wheat Annual Germplasm Upgrades Cotton Annual Germplasm Upgrades Canola/OSR Annual Germplasm Upgrades Rice Annual Germplasm Upgrades Wheat Disease Package Upgrades Veg- Annual Germplasm Upgrades Wheat Annual Germplasm Upgrades Cotton Annual Germplasm Upgrades Canola/OSR Annual Germplasm Upgrades Rice Annual Germplasm Upgrades Wheat Disease Package Upgrades Veg- Annual Germplasm Upgrades €21bn PSP Crop Science: Seed & Traits and Digital R&D Pipeline (Annual Update Feb 2023) Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 20
  • 21. Luna Flexx Super Nativo Delaro Forte Vayego Duo Velum LCM Rice Plant Hopper Life Cycle Management1 1 Shown here is a subset of Bayer’s total life cycle management activities; focused on new formulation developments which have the potential to bring significant innovation to customers compared to currently marketed product; Products shown may not yet be fully registered in all jurisdictions; includes all advancements made in FY’22, updated Feb’23; 2 SeedGrowth is currently reported within other SBEs; 3 3rd party collaboration PSP = Peak Sales Potential, 50% incremental; Expected to reach 30% of PSP by 2032, 80% of PSP by 2037 and remainder in 2038+; Note that products are excluded from the pipeline PSP typically the year following launch. Non-Selective Selective Glyphosate LCM Merlin Flexx / Adengo LCM advanced to next phase HERBICIDES FUNGIC. INSECT. SEED GROWTH 2 Phase II Phase III New AI Development New Herbicide New Herbicide New Herbicide New Fungicide New Fungicide Novel Mite Solution Plenexos Cereals, oilseed rape, sugarbeets, cotton and rice Fruits and vegetables Soybeans Corn Phase IV New Herbicide New Seed Treatment Balance Flexx LCM Convintro Mateno Complete Council Family Ronstar One Mesosulfuron LCM INS FUN ready mixture Redigo FS 25 Selection of projects listed here and included in the peak sales potential by segment do not include projects in early research or discovery New Insecticide New Herbicide New Fungicide3 New Seed Treatment New Herbicide3 Biological Small Molecule Phase I ~€4bn PSP ~€3bn ~€2bn New over-the-top herbicide €9bn PSP Crop Science: Crop Protection R&D Pipeline (Annual Update Feb 2023) Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 21
  • 22. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 22 Global sales development (€m, cpa growth rates) Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 US ex-US 1 Source: IQVIA, Jan 2023 2 mHSPC: metastatic hormone sensitive prostate cancer 3 nmCRPC: non-metastatic castration resistant prostate cancer 4 ARI: Androgen Receptor Inhibitor 178 76 106 127 158 Key sales drivers Q1 2023: US continues to be key growth driver, driven by mHSPC2 launch and ongoing nmCRPC3 gains Nubeqa now at #2 in 2nd generation ARIs4 for non- metastatic patients, set to become #2 in metastatic patients in its indications Additional approvals and strong launch momentum also drive sales dynamics in non-US regions Overall, Nubeqa approved in more than 80 countries (mHSPC approvals in 47 markets) US launch performance (monthly NBRx)1 - 100 200 300 400 500 600 700 800 Aug-22: mHSPC approval Pharmaceuticals: Nubeqa sales more than doubled again in Q1, continuing to gain market share
  • 23. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 23 Pharmaceuticals: Kerendia continues strong launch momentum since initial US launch in Aug 2021 Global sales development (€m, cpa growth rates) Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023 US ex-US Q1 2023: Continued US market uptake Significant growth in NBRx compared to Q1 2022 (>90%) Broad utility and relevance across GPs and specialists China: NRDL Listing starting March 2023 EU label extension reflecting results from Phase III study FIGARO-DKD Potential for further inclusion in treatment guidelines 1 Source: IQVIA, National NBRx, March 31, 2023 US launch performance (monthly NBRx)1 11 20 29 48 Key sales drivers 52 0 2.000 4.000 6.000 8.000 10.000
  • 24. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 24 11 Additions Discontinuations Newsflow Advancements Phase I Phase II Phase III Commercial Initiation of LGMD2i Gene Therapy (LION-101) Discontinuation of BDKRB1 Receptor Antagonist Discontinuation of P2X4 Antagonist Discontinuation of BDKRB1 Receptor Antagonist Neuropathic Pain (BRADiNP) Discontinuation of Runcaciguat (sGC Activator) CKD Darolutamide (AR Inhibitor) / Prostate Cancer with Biochemical Recurrence after Curative Radiotherapy (ARASTEP) Nubeqa (Darolutamide)  Approval in mHSPC in Europe, Japan and in China Eylea  EU and Japan submission of 8mg aflibercept (DME, nAMD) Oncology Cardiovascular Diseases Immunology & Inflammation Others Neurology / Rare Diseases Pharmaceuticals: R&D Developments (since last update on Feb 15, 2023)
  • 25. Bayer Q1 2023 Investor Conference Call /// May 11th, 2023 25 Full pipeline package available for download under: https://www.bayer.com/en/pharma/development-pipeline Pharmaceuticals: Pipeline Overview1 (as of Apr 26, 2023) Phase I Elimusertib (ATR Inhibitor) (BAY 1895344) AhR Inhibitor (BAY 2416964) mEGFR Inhibitor (BAY 2927088) DGKzeta Inhibitor (BAY 2965501) CCR8 Ab (BAY 3375968) Congestive Heart Failure Gene Therapy (AB-1002 formerly NAN-101) sGC Activator Oral (BAY 3283142) Anti-a2AP (BAY 3018250) sGC Activator Inhale (BAY 1211163) Bemdaneprocel (Parkinson’s Disease Cell Therapy) (BRT-DA01) Parkinson‘s Disease Gene Therapy (AB-1005 formerly AAV2-GDNF-PD) Multiple System Atrophy Gene Therapy (AB-1005 formerly AAV2-GDNF-MSA) Pompe Disease Gene Therapy (ACTUS-101) Huntington‘s Disease Gene Therapy (BV-101) LGMD2i Gene Therapy (LION-101) GPR84 Antagonist (BAY 3178275) * Including Precision Cardiovascular, Nephrology & Acute Care 1 Bayer and partner sponsored + 3rd party label enabling studies with first patient first visit 2 Pre-clinical selected assets on path to IND 3 Conducted by Merck & Co 4 US submission made by Regeneron Life cycle management New molecular entity Phase 02 DGKalpha Inh (BAY 2862789) PSMA TAC (BAY 3546828) PSMA SMOL TAC (BAY 3563254) VVD Keap1 Act (BAY 3605349) VVD STAT3 Inh (BAY 3630914) SEMA 3a (BAY 3401016) Anti-coagulant (BAY 3389934) Next Generation Liver MRI (BAY 3393081) Phase II Regorafenib (combi Nivolumab) (BAY 734506) Solid tumors (recurrent or metastatic) Asundexian (FXIa Inhibitor) (BAY 2433334) Major Adverse Cardiac Events Prevention (PACIFIC-AMI) Adrenomedullin Pegol (PEG-ADM) (BAY 1097761) Acute Resp. Distress Syn. (ARDS) (SEAL) Zabedosertib (IRAK4 Inh.) (BAY 1834845) Atopic Dermatitis (DAMASK) Gadoquatrane (High Relaxivity Contrast Agent) (BAY 1747846) Magnetic Resonance Imaging (HRCA-PAT) Runcaciguat (sGC Activator) (BAY 1101042) Non-prolif. Diabetic Retinopathy (NPDR) (NEON-NPDR) Phase III Copanlisib (PI3K Inhibitor) Non-Hodgkin Lymphoma (CHRONOS-4) Darolutamide (AR Inhibitor) Prostate Cancer (mHSPC) (ARANOTE) Adjuvant Prostate Cancer (DASL-HiCaP) Prostate cancer with biochemical recurrence after curative radiotherapy (ARASTEP) Finerenone (MR Antagonist) Heart Failure (HFmr/pEF) (FINEARTS-HF) Non-diabetic CKD (FIND-CKD) Vericiguat (sGC Stimulator) Heart Failure (HFrEF) (VICTOR3) Asundexian (FXIa Inhibitor) Stroke Prevention in Atrial Fibrillation (OCEANIC-AF) 2⁰ Stroke Prevention (OCEANIC-STROKE) Elinzanetant (Neurokinin-1,3 Rec Antagonist) Vasomotor Symptoms (OASIS) Biologic Antibody Cell Therapy Contrast Agent Gene Therapy Radiotherapy Small Molecule Submissions Aflibercept 8MG EU, JP, US4: Diabetic Macular Edema (DME) EU, JP, US4: Neovasc. Age-rel. Macular Degen. (nAMD) Oncology Cardiovascular* Neurology / Rare Diseases Immunology & Inflammation Others