Moderna, Inc.

Item 1. Legal Proceedings

We are involved in various claims and legal proceedings of a nature considered ordinary course in our business, including those described in our 2024 Form 10-K under the heading “Legal Proceedings.” Most of the issues raised by these claims are highly complex and subject to substantial uncertainties. For a description of risks relating to these and other legal proceedings we face, see Part I, Item 1A., “Risk Factors,” of our 2024 Form 10-K, including the discussion under the headings entitled “Risks related to our intellectual property” and “Risks related to the manufacturing of our commercial products and product candidates.” The outcome of any such proceedings, regardless of the merits, is inherently uncertain; therefore, assessing the likelihood of loss and any estimated damages is difficult and subject to considerable judgment.

Proceedings Related to Patents Owned by Arbutus

As more fully described in our 2024 Form 10-K, Arbutus Biopharma Corporation (Arbutus) and Genevant Sciences GmbH (Genevant) filed a complaint against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine willfully infringes certain U.S. patents concerning lipid nanoparticles. The Court has rescheduled trial to begin March 9, 2026.

Proceedings Related to Patents Owned by GSK

In July 2025, GlaxoSmithKline Biologicals SA (GSK) filed two lawsuits in Unified Patent Court (UPC) asserting that our manufacture and sale of Spikevax and/or mRESVIA infringe certain European patents owned by GSK concerning liposomes and modified liposomes for RNA delivery. The two actions seek relief in all UPC member states and in additional European Patent Convention contracting states. The complaints seek monetary and injunctive relief.

Proceedings Related to Patents Owned by Alnylam

As more fully described in our 2024 Form 10-K, Alnylam Pharmaceuticals, Inc. (Alnylam) has two proceedings against us in the U.S. District Court for the District of Delaware asserting that our manufacture and sale of our COVID vaccine infringes certain U.S. patents concerning cationic lipids. The Court entered a Final Judgment of non-infringement of all asserted patents in these lawsuits. In the first case, Alnylam appealed and the Federal Circuit Court of Appeals decided the appeal in our favor on June 4, 2025. The second case remains pending.