Beta Bionics (NASDAQ:BBNX) reported third-quarter net sales of $35.5 million, up about 30% from a year earlier, as new patient starts and recurring revenue from its pharmacy-channel user base supported growth. The company also raised the lower end of its full-year revenue outlook and outlined plans for the U.S. commercial launch of its Mint patch pump in the first quarter of 2027.
Chief Executive Officer Sean Saint said the company received FDA clearance in September for Mint, its patch pump designed to work with Beta Bionics’ automated insulin-delivery algorithm. The company expects Mint to be the smallest automated insulin-delivery patch pump in the U.S., with no recharging requirement, smartphone controls for iOS and Android, and integration with continuous glucose monitors.
Saint said Beta Bionics plans to begin fully commercializing Mint in the U.S. during the first quarter of 2027. The company completed a public offering during the third quarter that generated approximately $161 million in net proceeds, which it said will support Mint commercialization, manufacturing investment and other growth initiatives.
Third-Quarter Performance and Updated Outlook
Chief Financial Officer Stephen Feider said new patient starts increased by a mid-single-digit percentage from the prior quarter. About 69% of new patient starts were from people previously using multiple daily injections, while a high-30% percentage of new patients obtained the iLet system through the pharmacy channel.
Third-quarter gross margin was 57.3%, down 178 basis points sequentially but up 179 basis points from a year earlier. Feider said the quarterly margin result came in below expectations because of distributor stocking dynamics in the durable medical equipment, or DME, channel.
DME iLet sales declined sequentially even as DME new patient starts increased, because distributors supplied more iLets to patients than they purchased from Beta Bionics during the quarter. Meanwhile, distributor stocking of lower-margin supplies, including infusion sets and cartridges, offset much of the revenue impact but weighed on product mix and gross margin. The company expects revenue mix to normalize in the fourth quarter.
Total operating expenses rose 46% year over year to $46.9 million. The increase reflected expansion of the field sales organization and marketing investment, as well as research and development spending related to Mint and the company’s bi-hormonal program, according to Feider.
As of Sept. 30, Beta Bionics had about $374 million in cash equivalents and short- and long-term investments. The company said it expects fourth-quarter capital expenditures in the low- to mid-single-digit millions as it expands Mint manufacturing ahead of the planned launch.
- 2026 revenue guidance: $124 million to $126 million, compared with prior guidance of $121 million to $126 million.
- Fourth-quarter revenue expectation: $29 million to $31 million.
- Full-year pharmacy-channel mix expectation: 37% to 39% of new patient starts.
- Full-year gross-margin outlook: 58.5% to 59.5%.
The company previously anticipated that the Mint clearance could defer as much as $10 million of fourth-quarter iLet revenue as prospective customers waited for the patch pump. It now expects a potential deferral impact of up to $8.5 million, saying fewer users than initially expected appear to be delaying purchases.
Mint Launch, Manufacturing and Coverage
Beta Bionics said Mint can launch independently of its planned 3D Intelligence algorithm update. Saint said the company expects Mint output to begin near zero and build through 2027 as manufacturing capability is added. Beta Bionics has a baseline production operation with a single manufacturing line and is hiring toward four-shift operations, while future capacity expansion is expected to come largely from replicating manufacturing lines.
Feider said Mint’s gross margin will be dilutive in 2027, but the company expects the product’s margin profile to exceed that of the current patch-pump incumbent within three years. He attributed that outlook to Mint’s design, which includes a durable component expected to last two years and a lower-cost disposable component.
The company expects Mint to have insurance coverage for roughly 40% of U.S. lives at launch, increasing to around 50% by the end of 2027. Feider said Mint is considered a patch pump for reimbursement purposes, which he said should simplify the pharmacy-coverage process relative to a tubed pump.
Beta Bionics said it may prioritize new users if Mint demand initially exceeds manufacturing capacity. Feider added that some existing iLet users could transition to Mint over time, including users receiving supplies through either pharmacy or DME channels.
3D Intelligence Submission Withdrawn and Resubmission Planned
Beta Bionics withdrew its 510(k) submission for 3D Intelligence, an insulin-delivery algorithm intended to give clinicians three dosing-algorithm options while retaining the automation of the current iLet system. Saint said the FDA requested the withdrawal after additional questions remained at the end of the 90-day review period.
The company intends to submit a revised 510(k) application in mid-fourth quarter 2026. Saint said the algorithm itself will not change in the resubmission. Instead, the company is completing additional validation work related to its simulator, which was used as part of the submission.
“We do not believe there were any concerns with the algorithm itself,” Saint said. He described the issue as validation of the simulator rather than concerns involving clinical outcomes, individual algorithm modes or human factors.
Beta Bionics currently expects to launch iLet 3D and Mint 3D around mid-2027, subject to FDA clearance, though Saint said clearance as early as the fourth quarter of 2026 remains possible if the agency treats the resubmission as a continuation of the prior review.
Type 2 Diabetes and Pipeline Programs
The company completed enrollment in its real-world pivotal study involving adults with Type 2 diabetes. Beta Bionics expects the study could support an expanded U.S. indication for its algorithm in adults with Type 2 diabetes around mid-2027, subject to FDA clearance.
Saint said the company estimates that more than 30% of new patient starts during the third quarter were for people with Type 2 diabetes through off-label prescribing. Feider said Type 2 patient retention was slightly higher than Type 1 retention, though he said the difference was not substantial.
Beta Bionics also expects to begin a U.S. pivotal trial in coming weeks for a next-generation fully closed-loop algorithm for adults with Type 1 and Type 2 diabetes. The system is intended to remove meal announcements from the user experience. The company did not provide an approval timeline for that program.
In addition, Beta Bionics expects to launch iLet integration with Senseonics’ Eversense 365 continuous glucose monitor during the fourth quarter and plans to integrate Mint with Eversense 365 in the future. The company said drug reformulation for its bi-hormonal system is complete and that additional Phase IIa trials are being planned.
About Beta Bionics (NASDAQ:BBNX)
Beta Bionics, Inc (NASDAQ: BBNX) is a medical technology company focused on developing and commercializing automated insulin-delivery systems for people with insulin-dependent diabetes. Its principal product is the iLet Bionic Pancreas, an automated insulin-delivery system designed to help manage blood glucose levels with limited user input.
The iLet Bionic Pancreas combines a wearable insulin pump with continuous glucose monitoring technology and adaptive dosing algorithms. The system is designed to automatically adjust insulin delivery based on an individual’s glucose readings and requires users to provide relatively simple meal announcements rather than calculate precise carbohydrate amounts.
