Beta Bionics, Inc. Q4 FY2025 earnings call

• Beta Bionics had a strong first full year as a public company, with over 20,000 new users in 2025, doubling the installed base. • Outperformed key metrics for 2025, with strong sales growth and gross margin. • Developed Mint, a patch pump, and made progress on bihormonal system development. • Completed clinical trials for glucagon asset and bihormonal system feasibility. • Addressed FDA warning letter with remediation efforts, confident in resolving issues. • Pharmacy channel strategy successful, with agreements with major PBMs and increased new patient starts through pharmacy.

Full year 2025: Net sales were $100.3 million, up 54% y-o-y. Gross margin was 55.4%, up slightly y-o-y. New patient starts through pharmacy were in the high 20s percentage. Q4 2025: Net sales were $32.1 million, up 57% y-o-y. New patient starts were 5,592, up 37% y-o-y. Gross margin was 59%, up 179 basis points y-o-y. Pharmacy mix of new patient starts was a low 30s percentage in Q4, increasing from prior year's low teens.

• 2026 revenue expected to be $130 million to $135 million. • Pharmacy channel new patient starts expected to be 36% to 38%. • Gross margin expected to be between 55.5% and 57.5%. • Q1 2026 revenue expected to decline sequentially from Q4 2025. • Sales force to expand by at least 20 territories in 2026. • CapEx spend to accelerate predominantly related to Mint.

• Potential impact of FDA warning letter on quality systems and processes. • Competition in the durable pump market affecting contract conversations with PBMs and market share. • Perception of hypoglycemia events potentially affecting brand image, though data does not indicate outsized issues. • Seasonality affecting revenue cadence and gross margin.

Q: Phil Coover asked about conservatism in 2026 guidance and new patient starts embedded in guidance.

A: Stephen Feider said guidance is set with confidence, and massive outperformance in pharmacy new patient starts could create short-term revenue and gross margin headwinds.

Q: Michael Polark asked about Q4 starts performance and pump market starts.

A: Stephen Feider said no perspective on competitors' numbers yet.

Q: Mathew Blackman asked about Q1 2026 revenue decline and first half 2026 revenue weighting.

A: Stephen Feider explained Q1 expected decline due to seasonality and lack of prior year tailwinds, and first half 2026 revenue expected to be modestly higher than 2025 first half.

Q: Jonathan Block asked about sales territory expansion.

A: Stephen Feider and Sean Saint discussed deliberate expansion, aiming for 120-180 territories, with large expansion in first half 2026.

Q: Matthew O'Brien asked about 2026 guidance vs 2025 and gross margin.

A: Stephen Feider said no odd competitive factors, and gross margin guide accounts for potential pharmacy new patient starts outperformance.

Q: Michael Kratky asked about Q1 seasonality and pharmacy mix.

A: Stephen Feider explained Q1 seasonality and potential for pharmacy mix to outperform guide.

Q: Felipe Lamar asked about Mint checklist and pharmacy competition.

A: Sean Saint said no additional Mint status details, and Sean and Stephen discussed positive impact of competition on pharmacy momentum.

Q: Travis Steed asked about Q1 street models and OpEx.

A: Stephen Feider said Q1 street models are directionally accurate, and OpEx to increase with sales force expansion, R&D investments, and mild G&A increase.

Q: Frank Takkinen asked about pharmacy channel starts cadence and Phase IIb.

A: Sean Saint explained pharmacy channel starts cadence factors and Phase IIb's purpose to ensure success in pivotal trials.

Q: Danielle Antalffy asked about type 2 diabetes go-to-market strategy.

A: Sean Saint discussed importance of type 2 indication for primary care market.

Q: Jeffrey Cohen asked about R&D cadence and DME pricing.

A: Stephen Feider said consistent R&D investments, and DME channel pricing unchanged.