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Beta Bionics Inc. (BBNX-10.08%) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's financial performance, reporting a revenue increase to $65.1 million for 2024, up from $12.0 million in 2023. Despite the revenue growth, Beta Bionics incurred net losses of $54.8 million in 2024 compared to $44.1 million in 2023.
Beta Bionics focuses on the commercialization of the iLet Bionic Pancreas, an FDA-cleared device for the treatment of Type 1 diabetes (T1D) in adults and children aged six and older. The iLet autonomously manages insulin dosing without requiring users to count carbohydrates.
The company is pursuing a multi-channel coverage and reimbursement strategy to maximize access to the iLet, with efforts to expand coverage under both durable medical equipment (DME) and pharmacy benefit plan (PBP) channels.
Beta Bionics is developing additional products, including a patch pump and a bihormonal configuration of the iLet that combines insulin and glucagon delivery. The company has entered into a collaboration with Xeris Pharmaceuticals for the development of a glucagon product.
The filing notes the company's dependence on third-party suppliers for key components of the iLet and outlines risks related to supply chain disruptions.
Beta Bionics highlights ongoing regulatory compliance efforts, including a post-market surveillance study required by the FDA to assess the iLet’s safety and effectiveness.
The company acknowledges risks related to competition, intellectual property, and potential changes in healthcare regulations that could impact its business operations.
Beta Bionics is actively working to expand its market presence and enhance its product offerings to address the unmet needs of people with insulin-dependent diabetes.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Beta Bionics Inc. annual 10-K report dated March 25, 2025. To report an error, please email earnings@qz.com.