First FXIa Stroke Approval Wins China but Benefit Stays Narrowly Indication-Locked

Bayer's Q3 Performance Driven by Pharma Growth, Outlook Raised

Bayer reported increased sales of 10.053 billion euros (up 1.9% Fx & portfolio adj.) and EBITDA before special items of 1.615 billion euros (up 6.9%) in Q3 2026. The Pharmaceuticals division drove growth, entering a new cycle with strong performance from Nubeqa™ (up 58.3%) and Kerendia™ (up 64.9%). Notably, asundexian received approval in China for secondary stroke prevention under the brand name Sunharbo™, making it the first approved Factor XIa inhibitor worldwide. Against this backdrop, Bayer raised its full-year guidance for Group EBITDA before special items, free cash flow, and net financial debt, while Crop Science and Consumer Health performed in line with targets despite market pressures.

• Robust Financial Performance and Debt Reduction: Bayer's Q3 2026 saw group sales reach 10.053 billion euros, a 1.9 percent increase (Fx & portfolio adj.), and EBITDA before special items rise by 6.9 percent to 1.615 billion euros. Despite non-cash charges impacting core earnings per share (0.31 euros) and net income (minus 672 million euros), the company reduced its net financial debt to 31.083 billion euros by September 30, 2026, partly due to a 3.0 billion euro payment from Apollo Global Management Inc.
• Pharmaceuticals Division Drives Growth and Innovation: The Pharmaceuticals division experienced significant growth, with sales increasing by 6.4 percent (Fx & portfolio adj.) to 4.680 billion euros. This was primarily fueled by the strong performance of Nubeqa™ and Kerendia™, which saw sales jump by 58.3 percent and 64.9 percent, respectively. Nubeqa™ sales reached approximately one billion euros in Q3, while Kerendia™ achieved blockbuster status over the preceding 12 months.
• Strategic Regulatory Milestone and Improved Outlook: A key highlight was the approval of asundexian in China for secondary stroke prevention, marketed as Sunharbo™, marking it as the world's first approved Factor XIa inhibitor. This regulatory success, combined with strong operational performance, led Bayer to upgrade its full-year 2026 guidance for Group EBITDA before special items to between 9.8 and 10.3 billion euros, free cash flow to between minus 1.5 and minus 0.5 billion euros, and net financial debt to between 28.0 and 29.0 billion euros.
• Mixed Performance in Other Divisions and Litigation Progress: While Crop Science sales were down 2.4 percent (Fx & portfolio adj.) due to regulatory impacts and adverse weather, and Consumer Health sales remained flat (up 0.1 percent Fx & portfolio adj.) amidst a mixed market, both divisions performed in line with their targets. Additionally, Bayer secured a unanimous win in the first glyphosate Roundup™ trial since the U.S. Supreme Court decision, signaling progress in its litigation containment efforts.

Asundexian's Novel Factor XIa Inhibition in Secondary Stroke Prevention

Asundexian is a direct inhibitor of activated factor XIa (FXIa) evaluated combined with antiplatelet therapy for prevention of ischemic stroke after non-cardioembolic stroke or high-risk TIA. Milvexian is an oral, small-molecule inhibitor of factor (F) XIa undergoing evaluation in Phase 3 clinical trials for the same secondary stroke prevention setting in addition to background single or dual antiplatelet therapy.

Why New Options for Secondary Stroke Prevention Are Crucial

Current secondary stroke prevention relies heavily on antiplatelet and anticoagulant regimens, yet efficacy remains inconsistent across patient subgroups and clinical settings. Residual vascular risk, drug resistance, bleeding trade-offs, and cost pressures further limit long-term effectiveness.

• Reduced clopidogrel-aspirin benefit restricted by genetics and glycemic control: There was significant interaction between carrier status and antiplatelet therapy regimen on the risk of recurrent stroke (P=0.03) in patients with GA levels of ≤15.5%, but not in those with GA levels of >15.5% (P=0.48). Only in noncarriers with low GA levels, dual-antiplatelet therapy reduced stroke recurrence (3.5%) compared with those on aspirin alone (14.7%; hazard ratio, 0.23; 95% confidence interval, 0.10-0.49; P<0.001). No significant difference in bleeding was found among groups.

• Clopidogrel resistance and bleeding versus efficacy trade-off: clopidogrel resistance occurs in approximately 20% of Japanese and other Asian populations. A longer duration of DAPT after CAS is associated with lower rates of readmission for stroke, but increased risk of hemorrhagic complications, and the potential benefits of antithrombotic agents must be weighed against the corresponding increased risk of bleeding complications.

• Uncertain optimal duration of dual antiplatelet therapy after carotid artery stenting: The duration of DAPT after CAS remains controversial. The primary outcome did not differ significantly between the groups (2.5% versus 2.1%; adjusted hazard ratio of long-DAPT to short-DAPT, 0.869 [95% CI, 0.652-1.158]; P=0.337).

• Residual inflammatory risk not addressed by intensified antiplatelets: Compared with the bottom quartile, those in the top quartile (hsCRP>4.86 mg/L) were at increased risk of recurrent ischemic stroke (adjusted HR, 2.32; 95% CI, 1.15-4.68). There was no interaction with randomized antiplatelet treatment, and hsCRP did not predict the response to dual antiplatelets.

• High drug cost burden driven by anticoagulation: The total estimated annual drug expenditure was € 241,808; of which 51.6% was due to DOACs. Cardioembolic strokes had the highest annual costs per patient (€1328.6 [1169.0-1403.4]), while DAPT costs were highest for large-vessel strokes (p<0.001) and accounted for 2.5% of total costs.

Beyond Stroke: Asundexian's Expanding Clinical Development

Asundexian, a selective Factor XIa inhibitor, is furthest advanced for stroke prevention in high-risk atrial fibrillation, evaluated head-to-head against standard-dose apixaban in the phase 3 OCEANIC-AF trial. Broader evidence synthesis spans myocardial infarction, atrial fibrillation and ischemic stroke, with emerging interest in venous thromboembolism and acute coronary syndrome as potential long-term anticoagulation indications.