Beta Bionics Updates 2026 Revenue Outlook After Mint Clearance
Third-quarter 2026 net sales rose 30% to $35.5 million. Full-year revenue guidance is about $124 million to $126 million, reflecting a possible $8.5 million fourth-quarter deferral after FDA clearance of Mint.
Beta Bionics, Inc. (BBNX), a commercial-stage diabetes device company, reported third-quarter 2026 net sales of $35.5 million, up 30% year over year, and updated its 2026 revenue outlook to approximately $124 million to $126 million after FDA clearance of its Mint patch pump, while flagging that some prospective iLet users may wait for Mint’s launch.
The second-quarter release estimated full-year revenue of $131 million to $136 million, but the third-quarter release lists the prior range as $121 million to $126 million. Guidance now reflects a potential revenue deferral of up to $8.5 million in the fourth quarter of 2026. Beta Bionics said it expects Mint to recapture that revenue during 2027. Estimated gross margin of 58.5% to 59.5% and a 37% to 39% share of new patient starts reimbursed through the pharmacy benefit plan were unchanged.
Net sales for the quarter ended September 30, 2026 were $35.5 million, up 30% from $27.3 million a year earlier. Year-over-year growth slowed from 38% in the second quarter. Sales and marketing expense was $25.1 million. Loss from operations was $26.6 million, or negative 75% of sales. Net loss was $24.4 million, or $0.52 a share. Adjusted EBITDA was negative $18.9 million.
The pharmacy benefit plan channel was the growth engine. PBP net sales were $13.6 million, up 118% from $6.2 million a year earlier, after 153% growth in the second quarter. Durable medical equipment channel net sales were $21.9 million, up 4% from $21.0 million. Within DME, iLet sales were $11.6 million and single-use products were $10.3 million. PBP single-use products were $13.6 million. Gross margin was 57.3%.
New patient starts increased by a mid-single digit percentage versus the second quarter, after a sequential increase of at least 10% but less than 20% in that prior quarter. 69% of new starts came from multiple daily injections. A high 30s percentage of new starts were reimbursed through PBP.
Cash, cash equivalents, short- and long-term investments were $373.6 million as of September 30, 2026, after a public offering that raised approximately $161.3 million in net proceeds.
The company announced FDA clearance of Mint and expects a full U.S. commercial launch in the first quarter of 2027, with manufacturing capacity of at least 1.5 million total disposable units in full-year 2027. That timeline moved earlier than prior expectations to fully commercialize Mint by the end of the second quarter of 2027.
Following interactions with the FDA, Beta Bionics withdrew its 510(k) application for 3D Intelligence and intends to submit a revised application in mid-Q4 2026, with additional simulator validation data. It expects to commercialize 3D Intelligence in the United States as iLet 3D and Mint 3D in the first half of 2027, with the potential for an earlier launch in the fourth quarter of 2026, subject to FDA clearance.
The company completed enrollment for the U.S. pivotal trial of iLet in adults with type 2 diabetes and reiterated expectations to expand iLet’s indications around mid-year 2027, subject to FDA clearance. In the fourth quarter of 2026 it intends to initiate a pivotal trial of a next-generation fully-closed loop algorithm in adults with type 1 and type 2 diabetes. It also announced an agreement to integrate iLet and Mint with Senseonics’ Eversense 365 continuous glucose monitoring system, with commercial launch of the integrated iLet expected in the fourth quarter of 2026.