Beta Bionics (BBNX) Q4 2025 earnings summary

Executive summary

• Achieved $100.3 million in net sales for 2025, up 54% year-over-year, with Q4 net sales of $32.1 million, up 57% year-over-year.

• Installed base more than doubled to 35,011 users, with 19,713 new patient starts in 2025, up 52%.

• Strategic product launches and R&D milestones included unveiling the Mint patch pump, launching Bionic Circle and Color iLet, and completing first-in-human trials for the bihormonal system.

• Pharmacy channel strategy drove significant adoption and improved access, with formulary agreements across all major PBMs.

• Received an FDA warning letter in January 2026; remediation efforts are underway and not expected to impact timelines.

Financial highlights

• Q4 2025 gross margin reached 59%, up 179 basis points year-over-year; full-year gross margin was 55.4%.

• Q4 operating expenses were $35.1 million, with adjusted EBITDA loss of $10.5 million and net loss of $13.5 million.

• Ended 2025 with $265 million in cash and investments.

• Sequential quarterly revenue growth and margin improvement observed throughout 2025.

• Adjusted EBITDA and non-GAAP measures used to reflect core operating performance.

Outlook and guidance

• 2026 revenue guidance: $130–$135 million; gross margin expected between 55.5% and 57.5%.

• Expect 36–38% of new patient starts reimbursed through pharmacy channel in 2026.

• OpEx and CapEx to increase as a percentage of revenue, with higher sales/marketing and R&D spend, especially for Mint and bihormonal projects.

• Q1 2026 revenue and new patient starts expected to decline sequentially from Q4 2025, with first half 2026 revenue modestly higher than first half 2025.

• Additional Phase 2a feasibility trial for the bihormonal system planned for H1 2026, with Phase 2b to follow.