Beta Bionics, Inc. SEC 10-Q Report

Beta Bionics, Inc., a pioneering company in the medical device industry, has released its Form 10-Q report for the third quarter of 2025. The report showcases significant financial growth and operational advancements, driven by the strong market adoption of its innovative iLet device. The iLet, an FDA-cleared insulin delivery system, has been a key driver of the company's performance, reflecting its commitment to improving the lives of people with diabetes (PWD).

Financial Highlights

• Net Sales: $68.13 million, reflecting a significant increase from $44.68 million in the same period last year, driven by strong adoption of the iLet device.
• Gross Profit: $36.59 million, up from $24.20 million, indicating improved cost management and increased sales volume.
• Loss from Operations: $(55.56) million, compared to $(32.21) million, due to increased investment in research and development and sales and marketing efforts.
• Net Loss: $(59.73) million, widening from $(36.65) million, primarily due to higher operating expenses.
• Net Loss Per Share: $(1.52), an improvement from $(5.86) in the prior year, reflecting the impact of increased shares outstanding following the IPO.

Business Highlights

• Revenue Segments: The company’s revenues are predominantly generated from sales of the iLet and its associated single-use products. The iLet requires the use of separately purchased single-use products, which include cartridges for storing and delivering insulin, and infusion sets that connect the iLet to the user’s body. These single-use products generate recurring revenue as they are typically replaced every 2-3 days.
• Customer Segments: The company’s customers are distributors and pharmacies who sell these products to insulin-requiring people with diabetes (PWD) through the durable medical equipment (DME) and the pharmacy benefit plan (PBP) reimbursement channels. The majority of sales were through the DME channel.
• Sales Units: The iLet’s adoption is significant within the multiple daily injections (MDI) population, with approximately 70% of the iLet’s adoption through the nine months ended September 30, 2025, coming from PWD who were previously utilizing MDI.
• New Product Launches: The iLet is the first insulin delivery device cleared by the FDA to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. This marks a significant advancement over other insulin delivery technologies.
• Future Outlook: The company is focusing its initial commercialization efforts for the iLet in type 1 diabetes (T1D), an indication for which it received FDA clearance in patients six and older in May 2023, in the United States. The company believes that the iLet’s value proposition is resonating strongly within the MDI population.
• Partnerships: The company has partnered with Dexcom to enhance its product offerings and market reach.

SEC Filing: Beta Bionics, Inc. [ BBNX ] - 10-Q - Oct. 28, 2025