Beta Bionics, Inc. Q3 FY2025 earnings call

Q3 Performance: - Exceeded expectations across the board with $27.3 million net sales, 63% YOY growth. - Demand for iLet exceeded expectations with record new patient starts and higher percentage of new patient starts through pharmacy channel. - Gross margin improved to 55.5% due to scale, manufacturing volume leverage, and pharmacy installed base. ### Innovation Pipeline: - Mint patch pump in development: Continues to execute on timelines, confident in 510(k) clearance and scale manufacturing, aiming for end-2027 commercial launch. - Bihormonal pump program: Completed PK/PD bridging trial for glucagon asset, to initiate feasibility trial in Q4 2025. - iLet updates: Received special 510(k) clearance for feature updates to improve usability. - FDA Form 483: Remediation efforts underway related to customer complaint handling system and reporting criteria to MAUDE database, with revised reporting standards effective in late July.

In the third quarter of 2025, Beta Bionics delivered $27.3 million in net sales, which grew 63% year-over-year. The revenue growth was predominantly driven by 5,334 new patient starts in the quarter, which grew 68% year-over-year. Gross margin in the quarter was 55.5%, up 212 basis points compared to Q3 of 2024 and up 167 basis points sequentially relative to Q2 of 2025. The gross margin improvement was due to growth in the pharmacy installed base generating high-margin recurring revenue and lower cost per unit from higher manufacturing volumes.

• Raised full-year 2025 revenue guidance to over $96.5 million from prior $88 million to $93 million, projecting at least $28.5 million in Q4 2025. - Increased pharmacy mix of new patient starts guidance to 27% to 29% from prior 25% to 28%. - Raised full-year gross margin outlook to 54% to 55% from prior 52% to 55%, expecting Q4 gross margin to be in line with or improve slightly relative to Q3.

• FDA Form 483 related to customer complaint handling system and reporting criteria to MAUDE database, though remediation efforts are underway. - Potential impact of tariffs, but currently no concern about duty-free exemptions for iLet and its consumables.

Q: What's driving the momentum in demand and can you talk about the cadence of new starts in Q3 shaping Q4 assumptions?

A: Sean Saint mentioned demand driven by iLet being a new category taking time to be adopted, and Stephen Feider noted demand cadence was generally consistent across the quarter with no unusual timing.

Q: How does the government shutdown impact Mint launch timing?

A: Sean Saint stated it currently has no impact on Mint launch timing expectations.

Q: Can you give flavor on the remaining 30% of patients and future growth drivers?

A: Stephen Feider said 30% come from competitive pump systems roughly 1/3 from 3 primary competitors, and future demand will continue from MDI as market is underpenetrated.

Q: What are the steps for Mint full commercialization by end-2027?

A: Sean Saint said main steps are 510(k) clearance, manufacturing readiness, then launch, but specific internal program details not shared.

Q: How serious is the FDA 483 and remediation efforts?

A: Sean Saint said remediation efforts are well underway with new systems in place, and Stephen Feider explained it was due to differing interpretation of reportable complaints, now remediated with revised standards.

Q: On bihormonal timeline, how should we think about it?

A: Sean Saint said it's premature to put timelines out yet due to complexity, but progress is being made with completion of PK/PD and upcoming feasibility trial.

Q: How to quantify stocking headwind in pharmacy and tailwind in DME?

A: Stephen Feider said DME had favorable stocking dynamics in Q3 and pharmacy had unfavorable, with net neutral impact, and the metric of pharmacy supply kits per pharmacy patient per quarter can help understand retention.

Q: On pharmacy percentage and type 2 indication, can you elaborate?

A: Sean Saint said pharmacy percentage growth is hard to predict, and type 2 indication is not precluding growth, with new patient starts base growing but not specifically out selling it yet.

Q: On competitive landscape and gross margin guidance, any color?

A: Stephen Feider said competitive landscape is highly competitive, and gross margin guidance is cautious due to lack of predictability around pharmacy reimbursement and potential onetime charges.

Q: On 510(k) update and Mint development, how are they related?

A: Sean Saint said the 510(k) update is software related, some applicable to Mint and some not, with Beta Bionics focusing on user experience.

Q: How to think about MAUDE reports and remediation?

A: Sean Saint said it's common in the industry, guidelines are unclear, and Beta Bionics compares favorably, with no underlying problem in data, related to definition of reportable complaints.