Bayer Ag · XETR:BAYN
Bayer — ESC Congress 2024 Investor Webinar
33 slides from Bayer's conference presentation, Sep 2, 2024
Slide 1: Results from Finerenone in Heart Failure
HEALTH FOR ALL, HUNGER FOR NONE ESC Congress 2024: RESULTS FROM FINERENONE IN HEART FAILURE INVESTOR WEBINAR September 2, 2024
Slide 2: Agenda
. Agenda 01 Welcome 03 Thomas Kornek Vice President Investor Relations Prepared Remarks 02 Christoph Koenen Maria Borentain Bernardo Kanahuati Head of Head of Product Team Lead Clinical Development & Cardiovascular and Renal Kerendia, Operations, Clinical Development, Bayer Pharmaceuticals Bayer Pha
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
Slide 4: Finerenone: Potential to Make a Difference in Heart Failure
HEALTH FOR ALL, HUNGER FOR NONE Finerenone: POTENTIAL TO MAKE A DIFFERENCE IN HEART FAILURE INVESTOR WEBINAR Christoph Koenen September 2, 2024
Slide 5: Heart Failure Is a Huge Burden for Patients and Healthcare Systems
. Heart Failure Is a Huge Burden for Patients as Well as Healthcare Systems Characteristics Implications for of Heart Failure (HF) Healthcare Systems 64 million ~$346 billion total expenditure associated to people worldwide HF worldwide5 live with HF1 ~50% of 87% ofhospitalization overall HF costs d
Slide 6: HF Is a Complex Disease With Major Differences in Each Subtype
HF Is a Complex Disease With Major Differences in Each Subtype Requiring Different Treatment Approaches Scope of FINEARTS-HF HFrEF (LVEF ≤40%) HFmrEF (LVEF 41%-49%) HFpEF (LVEF ≥50%) Impaired ventricular contraction Mildly impaired ventricular Impaired ventricular filling contraction and/or ventricu
Slide 7: Highly Selective Inhibition of MR Overactivation With Finerenone
Highly Selective Inhibition of MR Overactivation With Finerenone to Address Fundamental Drivers of Disease Progression Vicious Cycle of Finerenone Halting the Vicious Worsening Disease Cycle by Blocking MR Overactivation Heart Failure // Highly selective inhibition Heart of the MR receptor – reducin
Slide 8: Finerenone's Clinical Profile Differs From Other MRAs
Due to Its Distinct Structural and Pharmacological Properties, Finerenone's Clinical Profile Significantly Differs from Other MRAs Structural and pharmacological properties of MRAs2 Characteristics of Finerenone Spironolactone Eplerenone Finerenone // Significant molecular and pharmacological differ
Slide 9: Key Study Results of FINEARTS-HF and FINE-HEART
HEALTH FOR ALL, HUNGER FOR NONE Finerenone: KEY STUDY RESULTS OF FINEARTS-HF AND FINE-HEART INVESTOR WEBINAR Maria Borentain September 2, 2024
Slide 10: FINEARTS-HF Evaluates Efficacy and Safety of Finerenone in HF
FINEARTS-HF Evaluates the Efficacy and Safety of Finerenone in Patients With HF and LVEF ≥40% N=6001* 1:1 R Finerenone 10, 20 and 40 mg od based on eGFR Matching placebo Max. dose 20 mg od for eGFR ≤60 ml/min/1.73 m2 Visits: Month 1, then 3-monthly for first year, Max. dose 40 mg od for eGFR >60 ml/
Slide 11: FINEARTS-HF Achieved Its Objective
FINEARTS-HF Achieved Its Objective Significantly Demonstrated Finerenone reached primary reduced the composite consistency across composite endpoint of CV death and all pre-specified total HF events subgroups Improved patient- Finerenone demonstrated Reduced reported health significant benefits
Slide 12: 16% Relative Risk Reduction in CV Death and Total HF Events
Finerenone Demonstrated Clinically Meaningful 16% Relative Risk Reduction in Composite of CV Death and Total HF Events Primary Endpoint: Composite of CV Death and Total HF Events 1,283 Events 50 Rate ratio = 0.84 (95% CI, 0.74–0.95), p=0.007 - Absolute rate reduction 2.8 per 100 patient-years* 17.7/
Slide 13: Reduction in Composite CV Outcome Driven by HF Events
The Statistically Significant Reduction in Composite CV Outcome Was Driven by a Reduction in HF Events Primary Components Of Endpoint Composite CV Outcome Outcome Finerenone Placebo RR (N=3003) (N=2998) (95% CI) n n Composite 0.84 CV Outcome 1083 1283 (0.74–0.95) p=0.007 0.82 Total HF Events* 842 10
Slide 14: Effects Consistent Regardless of LVEF and Background Therapy
Finerenone’s Effects On Primary Outcome Were Consistent Regardless of LVEF and Background Therapy, Including SGLT2i Primary Key sub-groups Endpoint Finerenone Placebo Category RR (95% CI) Events n/N E/100 p-yrs Events n/N E/100 p-yrs LVEF < 60% 877 512/2427 15.17 1061 594/2425 18.47 ≥ 60% 206 112/57
Slide 15: FINEARTS-HF Also Reached Key Secondary Endpoints
FINEARTS-HF Also Reached Key Secondary Endpoints Secondary Endpoints, hierarchical testing Finerenone Placebo Difference [1] (N=3003) (N=2998) (95% CI) RR: 0.82 Total HF Events 842 1024 (0.71, 0.94) p=0.0062 Diff: 1.56 Change in KCCQ-TSS to Months 6, 9 and 12, LS mean (SE) 7.99 (0.32) 6.43 (0.32)
Slide 16: Finerenone Was Well Tolerated
Similar to Previous Clinical Trials, Finerenone Was Well Tolerated Type of treatment-emergent safety outcome Finerenone (N=2993) Placebo (N=2993) Any SAE 38.7% 40.5% Serum creatinine ≥3.0 Mg/Dl 2.0% 2.1% Serum potassium >5.5 Mmol/L 14.3% 6.9 % >6.0 Mmol/L 3.0 % 1.4 % <3.5 Mmol/L 4.4 % 9.7 % Investig
Slide 17: FINEARTS-HF: Conclusions
FINEARTS-HF: Conclusions Among patients with HF with LVEF ≥40%, finerenone reduced the risk of the primary composite outcome of cardiovascular death and total HF events, reduced total HF events, and improved HF health status. The benefit appears to be early and the curves continue to separate over t
Slide 18: FINE-HEART: Largest Analysis Across the CKM Spectrum
FINE-HEART Represents The Largest Analysis of Efficacy and Safety of Finerenone Across the CKM Spectrum g ~19,000 Patients FINE-HEART is designed to assess the safety and efficacy of finerenone on CV death and other heart and kidney outcomes, and is enriched for participants with a high burden of CK
Slide 19: FINE-HEART: Benefits Across Cardio-Kidney Secondary Endpoints
In FINE-HEART, Finerenone Demonstrated Benefits Across Cardio- Kidney Secondary Endpoints Finerenone Placebo HR p-value (N=9,501) (N=9,490) (95% CI) No. of patients IR per No. of patients IR per Outcomes with event (%) 100py with event (%) 100py Primary Endpoint CV Death (excluding undetermined deat
Slide 20: FINE-HEART: Conclusions
FINE-HEART: Conclusions FINE-HEART with ~19,000 patients represents the largest analysis of efficacy and safety of the non-steroidal MRA finerenone across the CKM spectrum. Finerenone consistently shows benefits across a range of highly patient-relevant cardio-kidney outcomes incl. all-cause mortali
Slide 21: MOONRAKER to Further Strengthen the Profile for Finerenone
MOONRAKER To Further Strengthen the Profile for Finerenone in >15k Patients Across HF 1,2 3 Efficacy and safety profile of finerenone in patients Efficacy and safety profile of with symptomatic HF vs placebo (N=6001) finerenone when initiated early in patients hospitalised with HF vs placebo (N=5200
Slide 22: Kerendia: Building a True Cardiorenal Brand
HEALTH FOR ALL, HUNGER FOR NONE Kerendia: BUILDING A TRUE CARDIORENAL BRAND INVESTOR WEBINAR Bernardo Kanahuati September 2, 2024
Slide 23: FINEARTS-HF Marks a Key Moment for Patients With HF
FINEARTS-HF Marks a Key Moment for Patients with HF and LVEF ≥40% and Their Caregivers Summary of FINEARTS-HF and FINE-HEART 01 02 03 First MRA to Offers a new Potential to become a demonstrate proven potential treatment primary pillar of a multi- clinical benefit in all option for >50% of treatment
Slide 24: Getting Ready to Accelerate Kerendia's Growth
Getting Ready to Accelerate Kerendia’s Growth CKD/T2D HEART FAILURE Launched in 75 countries since 2021 First dossier to be submitted soon Included in most key international guideline Fast speed to launch readiness recommendations MOONRAKER study program ongoing >250k treated patients in US, JP & DE
Slide 25: FINEOVATE to Further Support Finerenone's Ambition
FINEOVATE to Further Support Finerenone’s Ambition as a Foundational Treatment Across the Spectrum of CKD and HF FINEOVATE Real-world evidence HF (LVEF ≤40) not on or Paediatric CKD not eligible to steroidal MRAs January 2028* 2024# Completion date tbc September 2028* March 2027* January 2028* Nondi
Slide 26: Bayer Is Committed to Improving Lives With Heart and Kidney Diseases
Bayer is Committed to Improving the Lives of People Living With Heart and Kidney diseases FINEARTS-HF and FINE-HEART are milestones towards a potential new foundational treatment option, bringing a new treatment option for >50% of patients with HF, in a highly underserved space. The next level evide
Slide 27: Q&A Session
Q&A Session Christoph Koenen Maria Borentain Bernardo Kanahuati Head of Head of Product Team Lead Clinical Development & Cardiovascular and Renal Kerendia, Operations, Clinical Development, Bayer Pharmaceuticals Bayer Pharmaceuticals Bayer Pharmaceuticals 27 Kerendia Investor Webinar /// September 2
Slide 28: Backup
HEALTH FOR ALL, HUNGER FOR NONE ESC Congress 2024: RESULTS FROM FINERENONE IN HEART FAILURE INVESTOR WEBINAR BACKUP September 2, 2024
Slide 29: FINEARTS-HF: Key Inclusion and Exclusion Criteria
FINEARTS-HF: Key Inclusion and Exclusion Criteria Key inclusion criteria Key exclusion criteria Aged ≥40 years eGFR <25 ml/min/1.73 m² HF diagnosis; NYHA class II–IV Serum plasma potassium >5.0 mmol/l (ambulatory or hospitalised primarily for HF) LVEF ≥40% measured within last 12 months MI or any ev
Slide 30: FINEARTS-HF: Baseline Characteristics
FINEARTS-HF: Baseline Characteristics Well-balanced Between Treatment Groups and Similar to Other Contemporary HFmr/pEF Trials1 Finerenone Placebo Finerenone Placebo (n=3003), n (%) (n=2998), n (%) (n=3003), n (%) (n=2998), n (%) Age, years, mean ± SD 72±10 72±10 Sex, female 45% 46% NT-proBNP, ng/mL
Slide 31: Consistent Across All Pre-specified Subgroups (1/3)
FINEARTS-HF: The Effects of Finerenone on the Primary Outcome Were Consistent Across All Pre-specified Subgroups (1/3) Including sex, region, LVEF and background medical therapy Finerenone Placebo Category RR (95% CI) Events n/N E/100 p-yrs Events n/N E/100 p-yrs Age (years) ≤ median (73.0) 468 278/
Slide 32: Consistent Across All Pre-specified Subgroups (2/3)
FINEARTS-HF: The Effects of Finerenone on the Primary Outcome Were Consistent Across All Pre-specified Subgroups (2/3) Including sex, region, LVEF and background medical therapy Finerenone Placebo Category RR (95% CI) Events n/N E/100 p-yrs Events n/N E/100 p-yrs NYHA Class II 646 375/2081 12.58 741
Slide 33: Consistent Across All Pre-specified Subgroups (3/3)
FINEARTS-HF: The Effects of Finerenone on the Primary Outcome Were Consistent Across All Pre-specified Subgroups (3/3) Including sex, region, LVEF and background medical therapy Finerenone Placebo Category RR (95% CI) Events n/N E/100 p-yrs Events n/N E/100 p-yrs ACEi, ARB or ARNI Yes 795 470/2379 1