Earnings

Beta Bionics Pulls Its 3D Intelligence FDA Filing And Warns Mint Could Defer Up To $8.5 Million

Third-quarter sales rose 30% to $35.5 million, but the loss widened and the 2026 revenue outlook narrowed to $124 million to $126 million.

Beta Bionics, which makes the iLet insulin pump, withdrew its FDA application for the 3D Intelligence dosing algorithm after recent interactions with the agency, the company said Tuesday as it reported third-quarter net sales of $35.5 million, up 30% from $27.3 million a year earlier. The net loss widened to $24.4 million.

A pharmacy-driven quarter

The growth came from the pharmacy benefit plan channel, where sales jumped 118% to $13.6 million from $6.2 million. The durable medical equipment channel rose 4% to $21.9 million from $21.0 million.

Gross margin improved to 57.3% from 55.5%. New patient starts rose by a mid-single-digit percentage from the second quarter, and 69% of them came from people previously on multiple daily injections.

The net loss was $0.52 per share, against $14.2 million, or $0.33 per share, a year earlier. Loss from operations reached $26.6 million, from $17.0 million, and adjusted EBITDA was negative $18.9 million, from negative $12.2 million. The company held $373.6 million in cash and investments at September 30, and said it raised about $161.3 million in net proceeds from a completed stock offering.

The Mint wait and the withdrawn filing

Beta Bionics now guides 2026 revenue to about $124 million to $126 million, narrowed from $121 million to $126 million. The range includes a potential deferral of up to $8.5 million in the fourth quarter, because new prospective iLet users could choose to wait for Mint, which the FDA has cleared. The company expects Mint to recapture any revenue lost in 2027, with a full U.S. launch in the first quarter of 2027.

On 3D Intelligence, the company's next-generation dosing algorithm, it plans to submit a revised 510(k) in mid-fourth quarter 2026 with additional simulator validation data. It still sees a possible launch in the fourth quarter of 2026, subject to FDA clearance, and otherwise expects to launch in the first half of 2027 as iLet 3D and Mint 3D.

What the iLet business looks like

Beta Bionics sells the iLet, an insulin pump that uses adaptive algorithms and glucose sensor data to decide and deliver all of a user's insulin doses. The FDA has cleared it for Type 1 diabetes in adults and children six years and older.

Other plans include expanding the iLet to adults with type 2 diabetes around mid-year 2027, subject to FDA clearance. Enrollment in its pivotal trial is complete. The company also plans to start a pivotal trial of a fully closed-loop algorithm in the fourth quarter, and expects an integrated iLet and Senseonics Eversense 365 sensor system to launch that quarter.

The company's guidance still calls for 37% to 39% of new patient starts to be reimbursed through the pharmacy channel and a gross margin of 58.5% to 59.5%, both unchanged.