What Moderna, Inc. told the SEC could break it.

Moderna uses a number of raw materials and excipients that may have a single source of supply, are new to the pharmaceutical industry and are employed in a novel manner — some not yet scaled to commercial supply — so unexpected manufacturing/testing failures or shortages could delay or interrupt clinical and commercial supply of its mRNA products.

“We utilize a number of raw materials and excipients that may have a single source of supply, are new to the pharmaceutical industry and are being employed in a novel manner. Some of these raw materials and excipients have not been scaled to a level to support commercial supply and could experience unexpected manufacturing or testing failures or supply shortages.”

A significant portion of Moderna's revenue is generated from a small number of entities (wholesalers/distributors, governments and organizations) that each accounted for more than 10% of total revenue and accounts receivable — concentrating revenue and collection risk as its overall product revenue has fallen sharply (from $6.8B in 2023 to $1.9B in 2025).

“A significant portion of our revenue to date has been generated from the following entities that accounted for more than 10% of total revenue and accounts receivable for the periods presented:”

Moderna's commercialization depends on facilities producing at commercial scale/yield; its new manufacturing plants in Australia, Canada and the UK carry operating risk, and it may rely on third parties for manufacturing, packaging, testing, warehousing, distribution and raw-material supply — arrangements it must secure on favorable terms to develop, manufacture and distribute products.

“Our new manufacturing plants in Australia, Canada and the United Kingdom are subject to risks associated with operating these facilities, and we may encounter difficulties in optimizing our global manufacturing network. To supplement our internal manufacturing infrastructure, we may rely on third parties for product manufacturing, packaging, testing, warehousing, distribution and other logistical services, and the manufacture and testing of raw materials, components, parts and consumables.”