Beta Bionics Inc's Business Segments

The company develops and commercializes the iLet, an automated insulin dosing system approved by the FDA for treating Type 1 Diabetes in adults and children aged six years and older. The iLet is the company's sole commercial product. The company is working to enhance the iLet's functionality, including the development of a bihormonal system that administers both insulin and glucagon for Type 1 Diabetes treatment; this requires further clinical development, regulatory approvals, and a new drug application submission for the glucagon component. Additionally, the company is in early stages of developing an insulin patch pump and is engaging with the FDA for clearance. The business faces risks related to clinical trials, regulatory approvals, manufacturing, intellectual property, market acceptance, competition, and reimbursement. Its success depends on completing clinical studies, securing and maintaining regulatory clearances, scaling manufacturing, launching commercial sales, and gaining acceptance from patients, medical professionals, and payors. The company currently has no other commercial products and may not develop additional marketable products. Its future growth and financial condition are subject to uncertainties, including trade regulations, tariffs, and international political tensions that could negatively impact operations and prospects.

The Company operates as a single operating segment, with the Chief Executive Officer serving as the Chief Operating Decision Maker (CODM). The CODM reviews financial information on a consolidated basis to make operating decisions, allocate resources, and evaluate financial performance. The primary measures of segment profit or loss used by the CODM are gross profit and net income (loss). The Company did not generate any international revenues nor hold material assets outside the United States for the years ended December 31, 2025 and 2024. Revenue is primarily derived from sales of the iLet device and its associated single-use products, distributed through a network of distributors and pharmacies. Revenue is recognized when control of goods transfers to customers, typically upon shipment. The Company treats the iLet and single-use products as separate performance obligations satisfied at a point in time. Access to the mobile application and unspecified software updates are considered distinct performance obligations satisfied over time during a four-year warranty period, with revenue recognized on a ratable basis over that period.