Beta Bionics (NasdaqGM:BBNX) Q3 2025 Earnings Call October 28, 2025 04:30 PM ET Company ParticipantsStephen Feider - CFOBlake Beber - Head of Investor RelationsSean Saint - CEOConference Call ParticipantsJeffrey Cohen - AnalystDavid Roman - AnalystJon Block - AnalystMatt O'Brien - Senior Research AnalystFrank Takkinen - Senior Research AnalystMike Kratky - Senior Research AnalystRichard Newitter - AnalystStephanie Piazzola - AnalystJeff Johnson - Senior Research AnalystMichael Polark - AnalystOperatorGood a ...

Financial Data and Key Metrics Changes - The company reported net sales of $27.3 million for Q3 2025, representing a 63% year-over-year growth [7] - Gross margin improved to 55.5%, up 212 basis points from 53.4% in Q3 2024 and up 167 basis points sequentially from 53.8% in Q2 2025 [10] - Total operating expenses increased to $32.2 million, a 62% rise compared to $19.9 million in Q3 2024 [14] - The company has approximately $274 million in cash and investments as of September 30, 2025, indicating strong capitalization for future initiatives [15] Business Line Data and Key Metrics Changes - The growth in revenue was driven by 5,334 new patient starts in Q3, which grew 68% year-over-year [8] - A low 30s percentage of new patient starts were reimbursed through the pharmacy channel, significantly higher than the high single-digit percentage in Q3 of the previous year [8][9] - Approximately 70% of new patient starts came from individuals previously using multiple daily injections, indicating market expansion [13] Market Data and Key Metrics Changes - The company has over 80% of insured lives in the U.S. covered under formulary agreements with pharmacy benefit managers [8] - The market for insulin pumps remains underpenetrated, with significant opportunities for growth from both type 1 and type 2 diabetes patients [40] Company Strategy and Development Direction - The company aims to disrupt the industry with innovative products like the iLet and the Mint patch pump, focusing on user experience and clinical outcomes [19][20] - The updated full-year 2025 guidance projects total revenue to exceed $96.5 million, up from previous guidance of $88 to $93 million [15][17] - The company is committed to driving adoption of the iLet under pharmacy benefits at the health plan level [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business direction, citing strong demand for the iLet and ongoing innovation in the pipeline [10][11] - The company anticipates continued growth in pharmacy mix and gross margin due to increased scale and high-margin recurring revenue from the pharmacy installed base [17][66] - Management acknowledged potential variability in new patient starts and pharmacy mix due to seasonal dynamics [16] Other Important Information - The company received a special 510(k) clearance for updates to the iLet, improving usability and reducing alert fatigue [23] - The FDA issued a Form 483 related to the company's customer complaint handling system, which management is addressing through remediation efforts [24][25] Q&A Session Summary Question: What is driving the momentum in revenue growth? - Management indicated that the success is due to the unique positioning of the iLet as a new category of device, with increasing adoption over time [33] Question: Can you elaborate on the patient demographics for new starts? - Approximately one-third of the remaining 30% of new patients are converting from competitive pump systems, with consistent demand patterns observed [39] Question: What is the impact of the FDA Form 483? - Management stated that they are actively addressing the issues raised and have implemented new systems to ensure compliance [49][50] Question: How does the government shutdown affect Mint's launch? - Management confirmed that the government shutdown does not currently impact their expectations for the Mint launch timeline [35] Question: What are the growth drivers for next year? - Continued understanding of the iLet and expansion of pharmacy adoption are expected to drive growth into next year [64][66]