Bayer Ag · XETR:BAYN
Bayer — Investor Presentation (November 2021)
22 slides from Bayer's investor presentation, Nov 15, 2021
Slide 1: Kerendia (Finerenone) - a new treatment option for CKD with T2D
Kerendia (Finerenone) - a new treatment option for CKD with T2D Investor-Webinar November 15, 2021 Christian Rommel, Head of R&D, Pharmaceuticals Sebastian Guth, Head of Commercial Operations Americas, Pharmaceuticals 1
Slide 2: Agenda
Agenda Welcome 1 Oliver Maier Head of Investor Relations 2 Prepared Remarks Christian Rommel Sebastian Guth Head of R&D, Head of Commercial Pharmaceuticals Operations Americas, Pharmaceuticals 3 Q&A 2 /// Finerenone Investor Webinar /// November 2021
Slide 3: Cautionary Statements Regarding Forward-Looking Information
Cautionary Statements Regarding Forward-Looking Information 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 ac
Slide 4: We laid the foundation for long-term growth at Pharma
We laid the foundation for long-term growth at Pharma Main building blocks of post LoE growth Late-stage Pipeline 1 Elinzanetant Pipeline in CV & WH (KaNDy NT-814) (e.g. FXI portfolio, PSP ≥ €1.0bn Eliapixant) PSP ~ €0.5bn PSP ≥ €1.0bn 2 Oncology Pipeline eg. EGFRexon20 inhib., ATR inhib., TTCs PSP
Slide 5: Kerendia is addressing an area of high unmet medical need
Kerendia is addressing an area of high unmet medical need Chronic Kidney Disease in Type-2-Diabetes • 160 mio patients globally • Shortens life expectancy by 16 years • #1 cause for dialysis / transplants Diabetes wasn’t a big deal to me. The problem was that it killed my kidneys and I didn’t know.
Slide 6: Multiple unmet needs exist in cardio-renal disease
Multiple unmet needs exist in cardio-renal disease 37 Million people in the US estimated to have CKD Patient needs HCP needs CKD with Type-2-Diabetes: CKD with T2D carries 3x risk of CV 71% of HCP confirm strong unmet A high-risk population death and is #1 cause of ESRD need despite SOC ~70% of HCPs
Slide 7: The Phase III trial program for Finerenone in CKD/T2D yields clinical advantage
The Phase III trial program for Finerenone in CKD/T2D yields clinical advantage Largest clinical program in CKD/T2D Broad spectrum of disease progression Clinical Advantage MOA known by Pooled data FIDELITY confirms cardio- renal benefits Physicians Physician Advantage: 7,437 Patients FIGARO-DKD exp
Slide 8: FIDELITY is a large, prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD
FIDELITY is a large, prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD 13,171 patients randomized across the CKD/T2D continuum Key eligibility criteria UACR (mg/g) Broad disease spectrum T2D 0–29 30–299 ≥300– Robust data in both early disease and late disease ≤5000 CKD ≥90 CV Composite (ml/
Slide 9: FIDELITY enrolled more early-stage patients than other contemporary trials in CKD/T2D
The FIDELITY program for Finerenone enrolled more early-stage patients than other contemporary trials in CKD/T2D Robust data in patients EARLY in CKD/T2D progression Clinical Earlier/broader CKD/T2D patient population than SGLT-2i Advantage which were mainly tested in higher-risk/late-stage patients
Slide 10: Early-stage patients represent the majority of the prevalent CKD/T2D patient population
Early-stage patients represent the majority of the prevalent CKD/T2D patient population Robust data in patients EARLY in CKD/T2D progression Clinical Earlier/broader CKD/T2D patient population than SGLT-2i Advantage which were mainly tested in higher-risk/late-stage patients MOA 4500 4.099 10000 8.6
Slide 11: Finerenone provides heart and kidney protection in patients with mild to severe CKD and T2D
Finerenone provides heart and kidney protection in patients with mild to severe CKD and T2D Key results of the FIDELITY pooled analysis 57% eGFR Clinical Advantage Composite CV Outcome Composite Kidney Outcome [K+] Hyperkalemia HR = 0.86 HR = 0.77 ~1% placebo adjusted MOA (95% CI 0.78-0.95), p=0.001
Slide 12: Finerenone cardio-renal risk reduction comparable to Canagliflozin when trial differences considered
Finerenone with cardio-renal endpoint risk reduction com- parable to Canagliflozin when trial differences are considered FIDELIO-DKD “CREDENCE-like” post-hoc analysis Reduction in cardio-renal endpoint risk1 • Post-hoc analysis of FIDELIO-DKD Clinical Finerenone Finerenone3 Canagliflozin 2 Advantage
Slide 13: Kerendia provides mechanistical continuity for the treatment of cardio-renal diseases
Kerendia provides mechanistical continuity for the treatment of cardio-renal diseases RAAS overactivation is a key driver of cardio-renal diseases Clinical ACEi/ARBs have been the gold-standard for treatment for decades Advantage Kerendia MOA intensifies RAAS inhibition via targeting MRA MOA known b
Slide 14: RAASi-intensification is accomplished with Kerendia on top of ACEi/ARBs
RAASi-intensification is accomplished with Kerendia on top of ACEi/ARBs 2020 Clinical Advantage • In Kerendia – Bayer has accomplished what many have tried and failed to do for the last 25 years MOA known by • RAASi-intensification through Kerendia continues Physicians the long RAAS-centric treatmen
Slide 15: Kerendia addresses familiarity of physicians with established mode of action
Kerendia addresses familiarity of physicians with established mode of action Mechanistic Continuity Clinical Advantage RAAS Inhibition RAAS Inhibition via MRA pathway MOA known by Physicians ACE inhibitors ARBs + ACEi/ARBs Physician Advantage: Familiarity • Well-entrenched historical paradigm may po
Slide 16: FDA approved Kerendia with a broad label recognizing renal and cardiovascular outcomes
FDA approved Kerendia with a broad label recognizing the renal and cardiovascular outcomes in FIDELIO-DKD US-Indication Indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in ad
Slide 17: Strong commitment to a broad availability to the cardio-renal potential of Kerendia
Strong commitment to a broad availability to the cardio-renal potential of Kerendia Launched Global Filed 11/2020 launch Peak sales potential > EUR 1bn Filed 2/2021 17 /// Finerenone Investor Webinar /// November 2021
Slide 18: Significant investment to tap into a targeted portion of the US primary care market
Significant investment to tap into a targeted portion of the US primary care market with Kerendia • Early focus on Nephrologists, Endocrinologists, select Cardiologists and targeted General Physicians Strategy • Breath of disease stages covered in the phase III program should facilitate adoption int
Slide 19: Life-cycle management for Finerenone into non-diabetic CKD and into heart failure
Life-cycle management for Finerenone into non-diabetic CKD and into heart failure Non-diabetic CKD Heart Failure CKD attributable to causes such as hypertension Targeting HF with a left ventricular ejection or chronic glomerulonephritis fraction of ≥40% (HFpEF). Reported cases of ESRD (US) HF patien
Slide 20: Kerendia sets the stage for a long-term cardio-renal vision
Kerendia sets the stage for a long-term cardio-renal vision and targets to deliver blockbuster potential Unmet Needs Kidney Dedicated CardioRenal Disease Modifier Need for RAASi intensification Need for earlier use in disease progression Need for disease Establish Kerendia as the Heart failure Non-d
Slide 21: Kerendia (Finerenone) - a new treatment option for CKD with T2D
Kerendia (Finerenone) - a new treatment option for CKD with T2D Investor-Webinar November 15, 2021 Christian Rommel, Head of R&D, Pharmaceuticals Sebastian Guth, Head of Commercial Operations Americas, Pharmaceuticals 21
Slide 22: Abbreviations
Abbreviations ACEi Angiotensin converting enzyme inhibitor PSP Peak sales potential AE Adverse event RAAS Renin-angiotensin-aldosteron system ARB Angiotensin receptor blocker RASi Renin-angiotensin-system inhibition/inhibitor BD&L Business development and licensing SGLT-2i Sodium-glucose-cotransport