Bayer Ag · XETR:BAYN

Bayer — Technical Presentation (November 2025)

15 slides from Bayer's technical presentation, November 2025

  1. Slide 1: Dosing, treatment patterns, UACR changes, and safety with finerenone in routine care

    Dosing, treatment patterns, UACR changes, and safety with finerenone treatment in routine care: FINE-REAL interim analysis Ricardo Correa-Rotter1, Christoph Wanner2, David C. Wheeler3, Lixin Guo4, Nihar R. Desai5, Sankar D. Navaneethan6, Susanne B. Nicholas7, Nan Hee Kim8, Jon Mares9, Sonia Ares Góm

  2. Slide 2: Disclosures

    2 Disclosures Dr. Correa Rotter discloses: • Funding for clinical trial participation and consulting fees from AstraZeneca, Bayer AG, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Roche • Honoraria for lectures from Amgen, AstraZeneca, Bayer AG, and Novo Nordisk • Travel support to attend the A

  3. Slide 3: Background/Methods

    3 Background/Methods • The non-steroidal mineralocorticoid receptor antagonist finerenone is approved for the treatment of CKD associated with T2D1,2 • FINE-REAL (NCT05348733) is the first global, prospective, observational study on the use of finerenone (10 or 20 mg) in participants (aged ≥18 years

  4. Slide 4: FINE-REAL included participants from 19 countries

    FINE-REAL included participants from 19 countries North America APAC (n=871; 25%) (n=1286; 36%) Canada (n=104; 3%) China mainland (n=297; 8%) United States (n=767; 22%) South Korea (n=716; 20%) Singapore (n=21; 1%) Taiwan (n=177; 5%) Thailand (n=75; 2%) EMEA (n=1103; 31%) Latin America Belgium (n=25

  5. Slide 5: Baseline demographics and disease characteristics

    5 Baseline demographics and disease characteristics N=3538 Age, mean (SD) 67.4 (11.1) Sex, n (%) Male 2363 (67) Female 1175 (33) BMI, median (IQR), kg/m2 (n=2725) 28.7 (25.2, 33.1) UACR, median (IQR), mg/g (n=2680) 334.4 (105.7, 910.7) eGFR,a mean (SD), mL/min/1.73 m2 (n=3440) 52.7 (22.1) Serum pota

  6. Slide 6: RAAS inhibitors and SGLT2 inhibitors were the most common concomitant medications

    RAAS inhibitors and SGLT2 inhibitors were the most common 6 concomitant medications 50 RAASi SGLT2i 40 39% GLP-1 RA Proportion of participants (%) 30 20% 20 16% 10 6% 6% 1% 2% 0 RAASi only SGLT2i only GLP-1 RA only RAASi + SGLT2i RAASi + GLP-1 RA SGLT2i + GLP-1 RAASi + SGLT2i + (n=707) (n=209) (n=45

  7. Slide 7: Finerenone 10 mg was most commonly used at initiation

    Finerenone 10 mg was most commonly used at initiation 7 100 n=5 n=106 n=9 n=416 n=9 n=46 83 80 Proportion of participants (%) n=591 60 40 20 17 0 n=1924 n=117 n=182 10 mg (n=2947) 4 20 mg (n=591) Finerenone dose • Of 991 participants with eGFR ≥60 mL/min/m2 who were eligible for 20 mg per label, 566

  8. Slide 8: Median UACR declined over time with finerenone use

    Median UACR declined over time with finerenone use Relative ΔBL: −37.1% Median relative ΔBL (95% CI): −36.8 (−41.8, −30.6) 400 Relative ΔBL: −30.8% Median relative ΔBL (95% CI): 350 334.4 −34.1 (−37.7, −30.5) 300 Median UACR (mg/g) 250 231.5 210.4 200 150 100 50 0 Baseline (n=2680) 4 months (n=1098)

  9. Slide 9: Treatment-emergent adverse events and serious treatment-emergent adverse events

    9 Treatment-emergent adverse events and serious treatment-emergent adverse events n (%) n (%) N=3538 N=3538 Any TEAE 1388 (39.2) Any serious TEAE, n (%) 408 (11.5) TEAE (>1.0%), n (%) Serious TEAE (>0.5%), n (%) Hyperkalemiaa 300 (8.5) Acute kidney injury 26 (0.7) Urinary tract infection 143 (4.0) H

  10. Slide 10: Conclusions

    10 Conclusions • By UACR and eGFR, participants in FINE-REAL had less advanced CKD versus FIDELIO-DKD1 • Use of concomitant RAASi, SGLT2i, or GLP-1 RA was higher in FINE-REAL than in typical real-world practice2–4 • Most participants (83%) were initiated on finerenone 10 mg • 57% (n=566) of particip

  11. Slide 11: Back-up slides

    11 Back-up slides 11

  12. Slide 12: Race and ethnicity

    12 Race and ethnicity n (%); N=3538 Race White 1560 (44) Black/African American 196 (6) Asian 1411 (40) American Indian/Alaska Native 20 (1) Native Hawaiian/Other Pacific Islander 6 (<1) Not reported 344 (10) Missing 1 (<1) Ethnicity Not Hispanic or Latino 2715 (77) Hispanic or Latino 415 (12) Not r

  13. Slide 13: UACR declined over time with finerenone use

    13 UACR declined over time with finerenone use N=3538 BL 4 months 12 months Total participants at each timepoint (N) 3538 2738 1717 n (%) with UACR data at BL and 4/12 months 2680 (76) 1098 (40) 617 (36) Median (IQR), mg/g 334.4 (105.7, 910.7) 231.5 (67.5, 687.0) 210.4 (55.0, 637.0) <30 mg/g, n (%)

  14. Slide 14: Course of UACR: Sensitivity analysis

    14 Course of UACR in participants with UACR data available at BL and 4 months or BL and 12 months: Sensitivity analysis N=3538 BL 4 months BL 12 months n (%) 1098 1098 617 617 382.10 231.50 346.02 210.43 Median (IQR), mg/g (123.00, 1012.00) (67.48, 687.00) (114.00, 859.00) (55.00, 637.00) Relative c

  15. Slide 15: Hyperkalemia events were serious in <1% of participants and none led to dialysis or death

    15 Hyperkalemia events were serious in <1% of participants and none led to dialysis or death n (%) N=3538 Any hyperkalemiaa event 300 (8) Study drug-related 246 (7) Leading to permanent discontinuation 35 (1) Serious hyperkalemiaa events 23 (1) Study drug-related 21 (1) Leading to permanent disconti

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