What Beta Bionics, Inc. told the SEC could break it.

Beta Bionics obtains some components and subassemblies for its iLet from single-source suppliers (some located in Switzerland, Mexico, China and Taiwan); partial or complete loss of one or more could cause significant production delays, inability to meet demand, and substantial revenue loss.

“We obtain some of the components and subassemblies included in our iLet from single source suppliers, and the partial or complete loss of one or more of these suppliers could cause significant production delays, an inability to meet customer demand and a substantial loss in revenue.”

Beta Bionics' top four durable medical equipment (DME) distributors represented approximately 52% of total sales for the year ended December 31, 2025; the company labels this a concentration risk and is pursuing a multi-channel DME/PBP strategy to mitigate it.

“For the year ended December 31, 2025, our top four DME distributors represented approximately 52% of our total sales. In order to mitigate this concentration risk, we are actively pursuing our multi-channel DME and PBP coverage and reimbursement strategy.”

Beta Bionics sources significant quantities of iLet components from foreign manufacturers including China and currently relies on Nairobi Protocol tariff exemptions for custom components; changes to those exemptions or broader tariff policy on medical-device imports from China could materially increase manufacturing costs and reduce profitability.

“While we currently benefit from tariff exemptions under the Nairobi Protocol for custom components used in the iLet and related supplies, any changes to these exemptions or broader tariff policies, particularly those affecting medical device imports from China, could materially increase our manufacturing costs and reduce our profi”