Glyphosate litigations
In June, the US Supreme Court issued a 7:2 landmark ruling in the Durnell Roundup™ (active ingredient: glyphosate) case, affirming that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts state-law-based failure-to-warn claims when the US Environmental Protection Agency (EPA) has made a definitive determination on product safety. This decision helps to bring significant containment to the Roundup™ litigation. It should result in the dismissal of current warnings-based claims and foreclose future claims based on state-failure-to-warn theories, which make up the vast majority of claims in the litigation to date.
Efficiency measures in the Crop Science Division
In July, we announced the consolidation of our glyphosate business in the United States into Ruveon LLC to optimize and align the business with the specific needs of the US market environment. Ruveon will be solely responsible for glyphosate in the United States and will focus on all aspects of the US glyphosate business, from pricing and go-to-market strategies to production and logistics. Ruveon is based in St. Louis, Missouri, and remains a Bayer Group business. The consolidation of the US glyphosate business is an executional step in the Five-Year Framework that the Crop Science Division presented last year to safeguard its global competitiveness.
Innovations and product approvals
Pharmaceuticals
In oncology, China’s National Medical Products Administration (NMPA) approved sevabertinib (brand name Hyrnuo™) in April as a monotherapy for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2-activating mutations who have received at least one prior systemic therapy. In May, the US Food and Drug Administration (FDA) granted Priority Review designation for sevabertinib as a first-line treatment of adult patients with HER2-mutated NSCLC.
In cardiovascular disease, the NMPA granted Priority Review designation in May to the marketing authorization application for our Factor XIa inhibitor asundexian for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack. Also in May, the marketing authorization applications for asundexian in the same indication were accepted by the FDA – also with Priority Review designation – and the Japanese Ministry of Health, Labor, and Welfare (MHLW); in June, the European Medicines Agency (EMA) positively validated the marketing authorization application. Additionally in May, we reported on the label extension granted for the marketing authorization of Kerendia™ by the NMPA in the treatment of adults with heart failure with left ventricular ejection fraction (LVEF) ≥40%. Also in May, the FDA accepted the supplemental New Drug Application (sNDA) and granted Priority Review designation for Kerendia™ for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes.
In radiology, we reported in June that gadoquatrane (brand name Ambelvist™) had been approved in the United States for use in contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system and other body regions in adult and pediatric patients, including term neonates.
Financing activities
In July, we successfully placed new bonds with a volume of US$ 5.0 billion (€4.4 billion), which were issued by our subsidiary Bayer US Finance LLC, United States, and guaranteed by Bayer AG. The placement comprised five tranches with maturities between 5 and 30 years and exclusively targeted institutional investors, with all tranches oversubscribed multiple times. Following this issuance, the US$ 8.0 billion bank loan facility signed in February was reduced to US$ 3.0 billion.
Likewise in July, we signed an agreement with US-based global asset management firm Apollo to improve our capital structure. Through this transaction, Apollo-managed funds and affiliates will obtain a minority stake in a newly established entity holding our long-acting reversible contraceptives (LARC) business against a contribution amounting to €3.0 billion. We will retain a majority stake in the entity and will continue to exercise operational control over the business. The investment will not result in any changes to the LARC strategy or business activities, which will continue to form part of the Bayer Pharmaceuticals Division’s core business, and the entity will remain fully consolidated in the Consolidated Financial Statements of the Bayer Group. We expect the transaction to close in the second half of 2026.