Beta Bionics Q4 Earnings Call Highlights

Key Points

• Beta Bionics reported strong commercial momentum with $100.3 million in 2025 net sales (up 54% YoY), Q4 sales of $32.1 million (+57% YoY), an installed base of >35,000 users after ~20,000 new iLet adopters in 2025, and 2026 guidance for $130–135 million in revenue and a 55.5–57.5% gross margin.
• Management disclosed a late-January FDA warning letter tied to quality-system findings from a June inspection (issues around complaint handling, MDRs, CAPA and trending), said remediation began immediately and expects old filings to be compliant by the end of Q2 without changing previously shared timelines.
• Pipeline progress includes the Mint patch pump tracking toward an unconstrained commercial launch by end-2027, successful first-in-human feasibility testing of its bihormonal system with no glucagon safety signals and further phase 2 work planned, while ~25–30% of Q4 new patient starts were off-label type 2 users and the company is exploring a type 2 label.

Beta Bionics NASDAQ: BBNX reported fourth-quarter and full-year 2025 results on its earnings call Tuesday, highlighting rapid user growth, expanding pharmacy reimbursement, and progress on its product pipeline while also addressing an FDA warning letter tied to quality-system observations.

Full-year 2025 results and iLet adoption

CEO Sean Saint said the company “outperformed substantially” against the targets it previously shared for 2025. Beta Bionics reported $100.3 million in net sales, up 54% year-over-year, and a 55.4% gross margin, which expanded slightly from the prior year.

Saint said close to 20,000 new users adopted the iLet in 2025, more than doubling the installed base entering the year. The company said its installed base now stands at more than 35,000 total users since launch.

Beta Bionics also emphasized its strategy to expand access through pharmacy reimbursement. Saint said the percentage of new patient starts through pharmacy rose to the high 20s% for full-year 2025, compared with a high single-digit percentage in the prior year, and noted the company has established formulary agreements with all major U.S. pharmacy benefit managers (PBMs).

Fourth-quarter performance exceeded guidance

For the fourth quarter, Beta Bionics reported $32.1 million in net sales, up 57% year-over-year. Saint attributed the growth to:

• 5,592 new patient starts in Q4, up 37% year-over-year
• A growing installed base obtaining monthly iLet supplies through the pharmacy channel, with management describing retention as high
• “Modest favorability” in stocking revenue in both the durable medical equipment (DME) and pharmacy channels

Management also disclosed a modest pull-forward of about $1 million in pharmacy stocking orders from Q1 into Q4 ahead of end-of-year price increases in that channel. The company said a low 30s% share of Q4 new patient starts were reimbursed through pharmacy, up from the low teens percentage in the year-ago quarter.

Gross margin in Q4 was 59%, up 179 basis points year-over-year. CFO Stephen Feider said the improvement was driven by the growing pharmacy installed base generating high-margin recurring revenue and lower cost per unit from higher manufacturing volumes.

Feider said approximately 69% of Q4 new patient starts came from people previously using multiple daily injections, which management characterized as evidence the iLet is expanding the pump market.

Expenses, cash position, and 2026 outlook

Beta Bionics reported $35.1 million in Q4 operating expenses, up from $24.7 million in Q4 2024. Feider said sales and marketing increased due to expansion of the field sales team, which ended Q4 with 63 territories. R&D increased due to the company’s Mint patch pump program and “Hormonal Projects,” while G&A rose with added costs from operating as a public company.

As of Dec. 31, 2025, the company reported approximately $265 million in cash, cash equivalents, and short- and long-term investments. Feider said the company is “sufficiently capitalized to fund all our key initiatives.”

For 2026, Beta Bionics guided to:

• Revenue of $130 million to $135 million
• 36% to 38% of new patient starts reimbursed through pharmacy
• Gross margin of 55.5% to 57.5%

Feider said guidance assumes continued market expansion and share gains, strong retention in both DME and pharmacy channels, stable DME pricing, and a low single-digit increase in pharmacy supply pricing. Management also noted that a higher-than-expected pharmacy mix can create a near-term headwind to revenue and gross margin under the pharmacy model, where the iLet is provided upfront and revenue is collected via monthly supplies.

On cadence, management expects Q1 revenue to decline sequentially from Q4, calling Q1 typically the softest quarter due to deductible resets. Feider said the Q4-to-Q1 decline should be larger than last year’s shift, which had been helped by late-2024 product launches and an early-2025 step change in pharmacy coverage. During Q&A, management said a street Q1 revenue estimate of about $27 million was “directionally accurate,” but it declined to provide quarterly gross margin guidance.

Beta Bionics said it plans to add at least 20 sales territories in 2026, with much of the expansion occurring in the first half. The company also said it will stop providing specific quarter-end territory counts and will no longer disclose exact quarterly new patient starts, while continuing to provide revenue by product and channel and the pharmacy mix of new patient starts.

FDA warning letter and remediation efforts

Saint addressed a warning letter received in late January related to an FDA inspection of the company’s Irvine facility in June 2025. He said the company began remediation immediately after receiving a Form 483 and does not believe the warning letter changes previously shared timelines.

Saint outlined the FDA’s key areas of concern, including complaint handling and medical device reporting (MDR) definitions, late MDR filings tied to changed reportability criteria, procedures for trending and analyzing complaint data, CAPA (corrective and preventative action) practices including verification of effectiveness, and corrections and removals reporting related to certain software updates. He said the company is on track to have old filings fully compliant by the end of Q2.

Pipeline updates: Mint patch pump, bihormonal system, and type 2 diabetes

On Mint, Beta Bionics’ patch pump program, Saint said development is “tracking well” toward internal milestones, with an “unconstrained commercial launch by the end of 2027.” He also said the company expects Mint to extend its presence beyond the durable pump segment and that existing iLet pharmacy relationships and contracts could be leveraged for Mint coverage.

For its bihormonal system, Saint said the company completed a first-in-human feasibility trial in New Zealand in Q4, marking the first time it tested the entire system, including its glucagon asset, in humans. He said the trial was “highly informative” and that the company continues to observe no safety signals for the glucagon asset. Beta Bionics said it is currently in a phase 2A feasibility stage and expects to initiate another phase 2A trial in the first half of the year, followed by a more robust phase 2B feasibility trial intended to support advancement into concurrent phase 3 pivotal trials.

Beta Bionics also discussed off-label use in type 2 diabetes, estimating 25% to 30% of Q4 new patient starts were from type 2 patients, up slightly from the prior quarter. While not committing to a timeline, management reiterated interest in pursuing a type 2 label through the FDA and noted that broader primary care marketing would differ from its endocrinology-focused approach.

About Beta Bionics NASDAQ: BBNX

Beta Bionics, a clinical-stage medical device company headquartered in Boston, Massachusetts, is focused on revolutionizing the management of type 1 diabetes through automated insulin delivery solutions. The company's flagship product, the iLet Bionic Pancreas system, is designed to simplify glycemic control by automatically adjusting insulin dosing in response to continuous glucose monitoring data. By integrating advanced algorithmic control with wearable infusion pumps, the iLet aims to reduce the daily burden of diabetes management and improve clinical outcomes for patients.

At the core of Beta Bionics' offering is its proprietary bionic pancreas software, which can operate in both insulin-only and dual‐hormone modes.

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