Bayer Ag · XETR:BAYN
Bayer — Technical Presentation (February 2026)
38 slides from Bayer's technical presentation, Feb 6, 2026
Slide 1: ISC 2026: Results from the OCEANIC-STROKE Phase III trial
ISC 2026: Results from the OCEANIC-STROKE Phase III trial Investor Webinar Friday 6 February, 15:00 – 16:00 CET
Slide 2: Today's Agenda
Today’s Agenda Welcome Alexander Siedler, Investor Relations Officer at Bayer Prepared Remarks Christoph Koenen, Global Head of Clinical Development & Operations at Bayer Ashkan Shoamanesh, Associate Professor of Medicine (Neurology), Marta and Owen Boris Chair in Stroke Research and Care at McMaste
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: Bayer's Vision for Secondary Stroke Prevention
Bayer’s Vision for Secondary Stroke Prevention Christoph Koenen Global Head of Clinical Development & Operations at Bayer
Slide 5: Stroke burden worldwide
Each year, approximately 12 million people worldwide will experience a stroke1 Stroke is also the third-leading Approximately cause of death… 101 million people worldwide are living second- and with the consequences of stroke2 leading cause of disability …1 5 1. World Stroke Organization. Global Fac
Slide 6: The risk of secondary stroke remains unacceptably high
The risk of secondary stroke remains unacceptably high, despite available secondary stroke prevention strategies Secondary strokes are more devastating than first strokes, with greater risk of disability, long-term cognitive decline, mortality, and higher healthcare costs than first strokes. ~1 in 5
Slide 7: Current Prevention Strategies Are Limited By Associated Bleeding Risk
Current Prevention Strategies Are Limited By Associated Bleeding Risk Recurrence rate of stroke is unchanged over >20 years, despite available secondary stroke prevention strategies1 7 World Stroke Organization, Impact of Stroke. Available at: https://www.world-stroke.org/world-stroke-day-campaign/a
Slide 8: Bayer's Heritage in Cardiovascular Disease
Bayer’s Heritage in Cardiovascular Disease Heart Failure with Reduced Ejection EMA approval of Beyonttra Fraction (HFrEF)16 for ATTR-CM20 10 Xarelto approved in VTE, Anti-a2ap in acute ischemic stroke/ SPAF, DVT, PE, ACSsp, pulmonary embolism as potential CAD/ PAD11,12 indications19 Pritor/ 6 Kerend
Slide 9: Asundexian: A Potential New Treatment Option in Secondary Stroke Prevention
Asundexian: A Potential New Treatment Option in Secondary Stroke Prevention Asundexian is the first FXIa inhibitor with a successfully completed phase III trial in secondary stroke prevention. • Pragmatic study design well representative of clinical Engagement with Health practice Authorities has be
Slide 10: OCEANIC-STROKE Study Results
OCEANIC-STROKE Study Results Ashkan Shoamanesh Associate Professor of Medicine (Neurology), Marta and Owen Boris Chair in Stroke Research and Care at McMaster University
Slide 11: Factor XIa Inhibition with Asundexian: Primary Results of OCEANIC-STROKE
FACTOR XIa INHIBITION WITH ASUNDEXIAN IN ACUTE NON-CARDIOEMBOLIC STROKE OR HIGH-RISK TRANSIENT ISCHEMIC ATTACK: PRIMARY RESULTS OF THE OCEANIC-STROKE TRIAL M. Sharma, Q. Dong, T. Hirano, S. Kasner, J. Saver, J. Masjuan, A. Demchuk, C. Cordonnier, D. Bereczki, G. Tsivgoulis, R. Veltkamp, I. Staikov,
Slide 12: Background
BACKGROUND • Genetic FXI deficiency associated with: Hemostasis Intravascular Thrombosis − reduced risk of ischemic stroke Tissue injury Intrinsic Intrinsic − without increased risk of ICH1–3 (contact) pathway (contact) pathway TF TF • FXI has a minor role in hemostasis but Extrinsic FXIIa Extrinsic
Slide 13: Asundexian
ASUNDEXIAN • Direct oral inhibitor of FXIa1,2 − Once daily dosing • No effect on bleeding time – alone or 100 Pre-dose=100% with DAPT Trough 90 Peak of FXla activity (%) 80 Ratio to baseline • Phase 2 studies >4000 participants 70 showed3–6 60 − >90% inhibition of FXIa at peak 50 and trough 40 − No
Slide 14: OCEANIC-STROKE Design
OCEANIC-STROKE Design • OCEANIC-STROKE − Placebo-controlled − Double-blinded − Event-driven Phase 3 RCT • Comparing asundexian 50 mg once daily and placebo • Patients with non-cardioembolic stroke or high-risk TIA − Planned for antiplatelet therapy – single or aspirin + P2Y12 inhibitor (clopidogrel,
Slide 15: OCEANIC-STROKE: Key Endpoints
OCEANIC-STROKE: KEY ENDPOINTS Endpoints (time to first occurrence) Primary efficacy* Primary safety Ischemic stroke ISTH major bleeding Secondary efficacy* Secondary safety • All strokes (ischemic and hemorrhagic) • Composite of ISTH major or CRNM bleeding • Composite of CV death, MI or stroke • IST
Slide 16: Key Inclusion and Exclusion Criteria
KEY INCLUSION AND EXCLUSION CRITERIA Key inclusion: • Participants aged ≥18 years, within 72 hours of symptom onset: − Non-cardioembolic ischemic stroke (NIHSS ≤15) or high-risk TIA (ABCD2 6 or 7) − History of atherosclerosis or evidence of plaque on imaging or non-lacunar stroke on imaging − Plan f
Slide 17: OCEANIC-STROKE: Study Design
OCEANIC-STROKE: STUDY DESIGN CEOT period safety Index Screening Intervention period follow-up 2 weeks after event ≤72 hours ~3–31 months stopping study drug Informed consent Asundexian 50 mg OD N≈6150 Adults ≥18 years with acute NCIS or high-risk Stratified by DAPT 1:1 TIA on (ASA + P2Y12 inhibitor)
Slide 18: CONSORT Diagram
CONSORT DIAGRAM Assessed for eligibility (n=12,578) Excluded (n=251) Not meeting inclusion criteria (n=201) Declined to participate (n=32) Randomized (n=12,327) Other reasons (n=18) Allocated to asundexian (n=6162) Allocated to placebo (n=6165) Received allocated intervention (n=6124) Received alloc
Slide 19: Baseline Characteristics
BASELINE CHARACTERISTICS Characteristics Asundexian 50 mg Placebo Randomized, N 6162 6165 Age, years, mean (SD) 67.7 (10.8) 67.5 (10.9) Female sex, n (%) 2063 (33.5) 2047 (33.2) Medical history, n (%) Previous history of stroke or TIA 1310 (21.3) 1345 (21.8) Coronary artery disease 949 (15.4) 1013 (
Slide 20: Index Event Characteristics
INDEX EVENT CHARACTERISTICS Characteristics Asundexian 50 mg Placebo Index event, n (%) Ischemic stroke 5839 (94.8) 5838 (94.7) High-risk TIA 323 (5.2) 325 (5.3) TOAST subtype of index event,† n (%) Large-artery atherosclerosis 2512 (43.0) 2484 (42.5) Stroke of undetermined etiology 1786 (30.6) 1710
Slide 21: Acute Treatment of Index Stroke
ACUTE TREATMENT OF INDEX STROKE Overall Asundexian 50 mg Placebo N=11677 N=5839 N=5838 Intravenous thrombolysis and/or endovascular 3201 (27.4) 1608 (27.5) 1593 (27.3) therapy,† n (%) Intravenous thrombolysis 2314 (19.8) 1146 (19.6) 1168 (20.0) only Endovascular therapy 371 (3.2) 202 (3.5) 169 (2.9)
Slide 22: Cumulative Incidence of Ischemic Stroke
CUMULATIVE INCIDENCE OF ISCHEMIC STROKE 12 HR: 0.74 (95% CI: 0.65–0.84) P value: <0.001* Placebo Cumulative incidence (%) 10 8 6 Asundexian 50 mg 4 2 0 0 60 120 180 240 300 360 420 480 540 600 660 720 780 Day from randomization No. at risk Placebo 6165 5949 5853 5754 5370 4840 4406 3990 3497 3070 25
Slide 23: Efficacy Outcomes
EFFICACY OUTCOMES Asundexian 50 mg Placebo (N=6162) (N=6165) Outcome n (%) n (%) csHR (95% CI)† P value‡ Primary efficacy event Ischemic stroke 384 (6.2) 518 (8.4) 0.74 (0.65–0.84) <0.001 Secondary efficacy events All strokes (ischemic, hemorrhagic) 404 (6.6) 545 (8.8) 0.74 (0.65–0.84) <0.001 CV dea
Slide 24: Safety Outcomes
SAFETY OUTCOMES Asundexian 50 mg Placebo (N=6162) (N=6165) Outcome n (%) n (%) csHR (95% CI)† Primary safety event ISTH major bleeding 117 (1.9) 107 (1.7) 1.10 (0.85–1.44) Secondary safety events ISTH major or clinically relevant non-major bleed 339 (5.5) 307 (5.0) 1.12 (0.96–1.30) Clinically releva
Slide 25: Cumulative Incidence of ISTH Major Bleeding
CUMULATIVE INCIDENCE OF ISTH MAJOR BLEEDING 12 HR: 1.10 (95% CI: 0.85–1.44) P value: 0.46* Cumulative incidence (%) 10 8 6 4 Asundexian 50 mg 2 Placebo 0 0 60 120 180 240 300 360 420 480 540 600 660 720 780 Day from randomization No. at risk Placebo 6130 5391 5021 4833 4415 3944 3572 3165 2775 2441
Slide 26: Subgroup Analyses for Ischemic Stroke
SUBGROUP ANALYSES FOR ISCHEMIC STROKE Asundexian 50 mg n/N (%) Placebo n/N (%) csHR (95% CI) Overall 384/6162 (6.2%) 518/6165 (8.4%) 0.74 (0.65–0.84) Age <65 yr 128/2313 (5.5%) 176/2308 (7.6%) 0.73 (0.58–0.92) 65–75 yr 152/2318 (6.6%) 197/2318 (8.5%) 0.76 (0.61–0.94) >75 yr 104/1531 (6.8%) 145/1539
Slide 27: Subgroup Analyses for Ischemic Stroke
SUBGROUP ANALYSES FOR ISCHEMIC STROKE Asundexian 50 mg n/N (%) Placebo n/N (%) csHR (95% CI) Brain imaging demonstrating an acute non-lacunar infarct No 193/3173 (6.1%) 266/3158 (8.4%) 0.72 (0.60–0.86) Yes 191/2989 (6.4%) 252/3007 (8.4%) 0.76 (0.63–0.92) Type of index event Ischemic stroke 358/5839
Slide 28: No Treatment Interaction for Efficacy Outcomes Across Ischemic Stroke Subtypes
NO TREATMENT INTERACTION FOR EFFICACY OUTCOMES ACROSS ISCHEMIC STROKE SUBTYPES Large-artery Small-vessel Stroke of atherosclerosis occlusion undetermined etiology Asundexia Asundexia Asundexia Placebo Asundexian Placebo Asundexian Placebo Asundexian n n n Inter. n (%) vs Placebo n (%) vs Placebo n (
Slide 29: Primary Efficacy Endpoint in Large-Artery Atherosclerosis Subgroup
CUMULATIVE INCIDENCE OF THE PRIMARY EFFICACY ENDPOINT OF ISCHEMIC STROKE IN THE LARGE-ARTERY ATHEROSCLEROSIS SUBGROUP 14 csHR: 0.82 (95% CI: 0.68–0.98) Cumulative incidence (%) P (log-rank test): 0.033 Placebo: LAA 12 10 8 Asundexian: LAA 6 4 2 0 0 60 120 180 240 300 360 420 480 540 600 660 720 780
Slide 30: Primary Efficacy Endpoint in Small-Vessel Occlusion Subgroup
CUMULATIVE INCIDENCE OF THE PRIMARY EFFICACY ENDPOINT OF ISCHEMIC STROKE IN THE SMALL-VESSEL OCCLUSION SUBGROUP 14 csHR: 0.68 (95% CI: 0.49–0.94) Cumulative incidence (%) P (log-rank test): 0.021 12 10 Placebo: SVO 8 6 Asundexian: SVO 4 2 0 0 60 120 180 240 300 360 420 480 540 600 660 720 780 Days o
Slide 31: Primary Efficacy Endpoint in Undetermined Etiology Subgroup
CUMULATIVE INCIDENCE OF THE PRIMARY EFFICACY ENDPOINT OF ISCHEMIC STROKE IN THE STROKE OF UNDETERMINED ETIOLOGY SUBGROUP 14 csHR: 0.61 (95% CI: 0.46–0.81) Cumulative incidence (%) P (log-rank test): <0.001 12 10 Placebo: Stroke of undetermined etiology 8 6 4 Asundexian: Stroke of undetermined etiolo
Slide 32: No Treatment Interaction for Safety Outcomes Across Ischemic Stroke Subtypes
NO TREATMENT INTERACTION FOR SAFETY OUTCOMES ACROSS ISCHEMIC STROKE SUBTYPES Large-artery Small-vessel Stroke of atherosclerosis occlusion undetermined etiology Asundexian Placebo Asundexian Asundexian Placebo Asundexian Asundexian Placebo Asundexian Inter. n (%) n (%) vs Placebo n (%) n (%) vs Plac
Slide 33: Consistent Results in Patients with Embolic Stroke of Undetermined Source
CONSISTENT RESULTS IN PATIENTS WITH EMBOLIC STROKE OF UNDETERMINED SOURCE ESUS No ESUS Asundexian Asundexian Inter. Asundexian Placebo vs Placebo Asundexian Placebo vs Placebo P- Endpoints n (%) n (%) HR (95% CI)† n (%) n (%) HR (95% CI)† value N=924 N=920 – N=4914 N=4918 – Primary efficacy endpoint
Slide 34: Conclusion
CONCLUSION • OCEANIC-STROKE enrolled a large representative sample of non-cardioembolic ischemic stroke subtypes. • Asundexian reduced ischemic and disabling stroke, without increasing ISTH major bleeding or intracranial hemorrhage across all qualifying ischemic stroke subtypes. • These findings wer
Slide 35: Asundexian's Potential in Secondary Stroke Prevention
Asundexian’s Potential in Secondary Stroke Prevention Jan F. Voss Senior Vice President, Global Head Asundexian at Bayer
Slide 36: Stroke presents an overwhelming financial burden for healthcare systems and patients
Stroke presents an overwhelming financial burden for both healthcare systems and patients Preventing recurrent strokes could alleviate economic burden, free up healthcare resources, and allow for more stroke survivors to remain productive. The economic burden of stroke The humanistic burden • The gl
Slide 37: Bayer's Asundexian – A Groundbreaking Moment for Secondary Stroke Prevention
Bayer’s Asundexian – A Groundbreaking Moment for Secondary Stroke Prevention The Phase III OCEANIC-STROKE study signals a breakthrough in secondary stroke prevention, with asundexian significantly reducing ischemic stroke, without increasing ISTH major bleeding, compared to placebo with antiplatelet
Slide 38: Q&A
Q&A Please follow the instructions provided to ask your questions.