Beta Bionics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net sales reached $35.5 million for the quarter ended September 30, 2026, representing a 30% increase from $27.3 million in the same period of 2025.
• Durable Medical Equipment (DME) channel net sales were $21.9 million, up 4% year-over-year from $21.0 million.
• Pharmacy Benefit Plan (PBP) channel net sales were $13.6 million, up 118% year-over-year from $6.2 million.
• Gross margin improved to 57.3%, an increase of 179 basis points compared to 55.5% in the third quarter of 2025.
• Loss from operations was $26.6 million (negative 75% of sales), compared to $17.0 million (negative 63% of sales) in the prior year quarter.
• Net loss was $24.4 million (negative 69% of sales), compared to $14.2 million (negative 52% of sales) in the prior year quarter.
• Adjusted EBITDA was negative $18.9 million (negative 53% of sales), compared to negative $12.2 million (negative 45% of sales) in the prior year quarter.
• Cash, cash equivalents, short-term investments, and long-term investments totaled $373.6 million as of September 30, 2026.
• For the nine months ended September 30, 2026, net sales were $95.1 million compared to $68.1 million in the prior year period.

Guidance and Future Outlook:

• Full-year 2026 revenue guidance was updated to approximately $124 million to $126 million, previously $121 million to $126 million.
• The revenue guidance reflects a potential deferral impact of up to $8.5 million in the fourth quarter of 2026 due to prospective users awaiting the Mint launch.
• The Company expects Mint to recapture any revenue lost in the fourth quarter of 2026 during the full year 2027.
• Full-year 2026 guidance for new patient starts reimbursed through the PBP channel remains 37% to 39%.
• Full-year 2026 guidance for gross margin remains 58.5% to 59.5%.
• Mint is expected to launch commercially in the first quarter of 2027 with manufacturing capacity to produce at least 1.5 million disposable units in 2027.
• 3D Intelligence is expected to be commercialized as iLet 3D and Mint 3D in the first half of 2027, with a potential earlier launch in Q4 2026 subject to FDA clearance.
• The Company intends to submit a revised 510(k) application for 3D Intelligence in mid-Q4 2026.
• Expansion of iLet indications for adults with type 2 diabetes is expected around mid-year 2027, subject to FDA clearance.
• A pivotal trial for a next-generation fully-closed loop (FCL) algorithm in adults with type 1 and type 2 diabetes is scheduled to initiate in Q4 2026.

Business Segments and Product Lines:

• New patient starts increased by a mid-single digit percentage versus the second quarter of 2026.
• 69% of new patient starts originated from patients previously on multiple daily injections (MDI).
• Approximately 38% (high 30s) of new patient starts were reimbursed through the PBP channel.
• FDA clearance was announced for Mint, with a full U.S. commercial launch planned for Q1 2027.
• The Company unveiled 3D Intelligence as its next-generation insulin dosing algorithm.
• The 510(k) application for 3D Intelligence was withdrawn to allow for the submission of additional simulator validation data.
• Enrollment for the U.S. pivotal trial studying the iLet in adults with type 2 diabetes was completed.
• The FCL algorithm in development removes the meal announcement feature, requiring only the user's body weight at pump initialization.
• An agreement was announced to integrate the iLet and Mint with Senseonics' Eversense 365 continuous glucose monitoring system.
• The commercial launch of the integrated iLet and Eversense 365 system is expected in Q4 2026.

Market and Competitive Landscape:

• The Company operates in the advanced diabetes management solutions market, focusing on adaptive closed-loop algorithms.
• The PBP channel demonstrated significant growth, increasing sales by 118% year-over-year.
• The majority of new patient starts (69%) are coming from patients transitioning from multiple daily injections.

Risks and Challenges:

• Regulatory clearance is required for the commercialization of 3D Intelligence, iLet 3D, Mint 3D, and the expanded iLet indications for type 2 diabetes.
• The withdrawal of the 510(k) application for 3D Intelligence and the need for a revised submission present potential delays.
• Revenue deferral of up to $8.5 million in Q4 2026 is anticipated as customers wait for the Mint launch.
• Manufacturing capacity must be scaled to meet the anticipated demand for Mint starting in 2027.
• The Company continues to report operating losses and negative adjusted EBITDA.
• Future results are subject to risks related to clinical trial outcomes, regulatory approvals, financing, manufacturing, and supply chain management.

Management Commentary and Tone:

• Management reiterated expectations for product launches and regulatory clearances despite recent application withdrawals.
• The Company highlighted the completion of the type 2 diabetes pivotal trial and the initiation of the next-generation FCL algorithm trial.
• Strategic moves include the integration with Senseonics and the public offering of common stock.

Other Key Points:

• The Company completed a public offering of common stock, raising approximately $161.3 million in net proceeds.
• The Company hosts a conference call and webcast to review third-quarter 2026 performance.
• Non-GAAP financial measures, including Adjusted EBITDA, are used to evaluate operating performance, excluding items such as depreciation, stock-based compensation, interest income, and quality system remediation costs.
• Quality system remediation expenses relate to one-time efforts in response to an FDA Form 483 and Warning Letter.