Core Insights - Beta Bionics, Inc. (BBNX) reported revenue of $27.25 million for the quarter ended September 2025, showing no change from the same period last year, with an EPS of -$0.33 compared to $0 in the previous year [1] - The revenue exceeded the Zacks Consensus Estimate of $23.92 million by +13.96%, while the EPS surprised positively by +26.67% against the consensus estimate of -$0.45 [1] Revenue Breakdown - Total DME channel revenue was $21.02 million, surpassing the average estimate of $16.22 million from two analysts [4] - Total PBP channel revenue reached $6.24 million, exceeding the average estimate of $5.65 million from two analysts [4] - PBP channel revenue from single-use products was $6.09 million, compared to the average estimate of $5.94 million [4] - DME channel revenue from single-use products was $6.84 million, exceeding the average estimate of $5.48 million [4] - PBP channel revenue from iLet was $0.15 million, below the average estimate of $0.5 million [4] - DME channel revenue from iLet was $14.18 million, surpassing the average estimate of $10.74 million [4] Stock Performance - Beta Bionics, Inc. shares have returned +19.6% over the past month, significantly outperforming the Zacks S&P 500 composite, which changed by +3.6% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

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]

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] - Cash, cash equivalents, and investments stood at approximately $274 million as of September 30, 2025, indicating sufficient capitalization for key initiatives [15] Business Line Data and Key Metrics Changes - The growth in revenue was driven by 5,334 new patient starts, which grew 68% year-over-year [8] - Approximately 70% of new patient starts in Q3 came from individuals previously using multiple daily injections, indicating market expansion [13] - The percentage of new patient starts reimbursed through the pharmacy channel was in the low 30s, significantly higher than the high single-digit percentage from the previous year [8][9] Market Data and Key Metrics Changes - Over 80% of insured lives in the U.S. are covered under formulary agreements with major pharmacy benefit managers (PBMs) [8] - The company expects 27%-29% of new patient starts to be reimbursed through the pharmacy channel for the full year 2025, an increase from prior guidance [15][16] Company Strategy and Development Direction - The company aims to disrupt the diabetes management industry with innovative products like the iLet and the Mint patch pump [19][20] - The focus remains on driving adoption of the iLet as a pharmacy benefit at the health plan level [9] - The company is committed to expanding its pipeline with new features and products to enhance user experience and clinical outcomes [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business direction, citing strong demand for the iLet and positive real-world outcomes [10][11] - The company raised its full-year 2025 revenue guidance to over $96.5 million, up from previous estimates [15] - Management acknowledged potential variability in pharmacy mix due to seasonal dynamics and ongoing adoption efforts [16] Other Important Information - The company received a special 510(k) clearance for updates to the iLet, improving usability and reducing alert fatigue [23] - A Form 483 was issued by the FDA regarding the company's complaint handling system, but management is confident in their 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 on operations? - Management stated that they are actively addressing the issues raised and have implemented new systems to ensure compliance [49][50] Question: How does the company view future pharmacy channel growth? - Management expressed uncertainty in predicting specific thresholds for pharmacy channel penetration but aims to maximize the number [92]

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 [13] - The company has approximately $274 million in cash and investments as of September 30, 2025, indicating strong capitalization for future initiatives [14] 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 30% of new patient starts were reimbursed through the pharmacy channel, significantly higher than the high single-digit percentage in Q3 2024 [8][9] - Approximately 70% of new patient starts came from individuals previously using multiple daily injections, indicating market expansion [12] Market Data and Key Metrics Changes - The company has over 80% of insured lives in the U.S. covered under formulary agreements with major pharmacy benefit managers (PBMs) [8] - The pharmacy mix of new patient starts is projected to be between 27% to 29% for the full year 2025, up from prior guidance of 25% to 28% [14][15] Company Strategy and Development Direction - The company aims to disrupt the diabetes management industry with innovative products like the iLet and the upcoming Mint patch pump [6][18] - The focus remains on driving adoption of the iLet as a pharmacy benefit at the health plan level [9] - The company is committed to building a robust pipeline of innovative solutions to transform diabetes management [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business direction, citing strong demand for the iLet and positive real-world outcomes [10][11] - The company anticipates continued gross margin expansion due to increased scale and manufacturing volume leverage [10][16] - Management acknowledged potential variability in pharmacy mix due to seasonal dynamics and ongoing adoption efforts [15] Other Important Information - The company received a special 510(k) clearance for updates to the iLet, improving usability and reducing alert fatigue [22] - Remediation efforts related to an FDA Form 483 are underway, with expectations to complete by Q2 2026 [24][26] - Over 25% of new patient starts in Q3 were from type 2 diabetes patients, consistent with prior quarters [27] 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 [32] Question: Can you elaborate on the patient demographics for new starts? - The remaining 30% of new patients are coming from competitive pump systems, with a consistent split among primary competitors [37] Question: What is the impact of the FDA Form 483? - Management stated that they are aggressively addressing the issues raised and have implemented new systems to align with FDA standards [45][46] Question: What are the growth drivers for next year? - Continued understanding of the iLet, pharmacy adoption, and high retention rates from the pharmacy installed base are expected to drive growth [56][58] Question: What is the timeline for the biohormonal system? - Management refrained from providing specific timelines but confirmed that they are working towards initiating a feasibility trial [66]

Q3 2025 Financial Performance - Revenue reached $27.3 million in Q3 2025[38] - Gross profit margin was 55% in Q3 2025[38] - New patient starts totaled 5,334 in Q3 2025[13] - Approximately 70% of new patient starts in Q3 2025 came from multiple daily injections[14] - New patient starts reimbursed through pharmacy were in the low 30s % in Q3 2025[14] Strategic Initiatives - The company launched the Color iLet in October 2024, featuring a color screen and brighter display[17] - The company launched Libre 3 Plus Integration in November 2024, which is the first insulin pump in the U S to integrate with Abbott's Freestyle Libre 3 Plus[17] - The company released Bionic Portal Update in May 2025, allowing HCPs to access real-time clinical outcomes for their patients[18] - The company has effective formulary agreements in place with all major PBMs operating in the U S as of July 2025[21] - The company received iLet Special 510(k) Clearance in September 2025 for usability improvements and a faster cartridge change process[22] Full Year 2025 Guidance - The company projects total revenue to be greater than $96.5 million for the full year 2025[25] - The company anticipates a gross margin of 54-55% for the full year 2025[25] - The company expects new patient starts through pharmacy to be 27-29% for the full year 2025[25]

Q2 2025 Financial Performance - Revenue reached $23.2 million[11], a significant increase from $0.6 million in Q2 2023[11] - Gross margin was 54% in Q2 2025[11], compared to 4% in Q2 2023[11] - New patient starts totaled 4,934 in Q2 2025[11], up from 31 in Q2 2023[11] - Approximately 71% of new patient starts in Q2 2025 were reimbursed through pharmacy[13] - Net loss was $16.9 million in Q2 2025[31] Full Year 2025 Guidance - Total revenue is projected to be between $88 million and $93 million[21] - Gross margin is expected to be between 52% and 55%[21] - New patient starts through pharmacy are anticipated to be between 25% and 28%[21] Strategic Initiatives - The company launched Bionic Circle in September 2024, a remote monitoring app[16] - The company launched Color iLet in October 2024, featuring a color screen[16] - The company integrated with Abbott's Freestyle Libre 3 Plus in November 2024[16] - The company completed dosing for the Glucagon Development PK/PD bridging study in Canada in July 2025[19]

Financial Performance - Q1 2025 revenue reached $17.6 million[11], compared to $12.9 million in Q1 2024[11] - Gross margin in Q1 2025 was 51%[11], a decrease from 56% in Q1 2024[11] - Net loss for Q1 2025 was $28.7 million[30], compared to a net loss of $12.4 million in Q1 2024[30] - Adjusted EBITDA for Q1 2025 was ($15.5) million[30], compared to ($7.8) million in Q1 2024[30] Key Metrics - New patient starts in Q1 2025 were 3,853[11], compared to 2,597 in Q1 2024[11] - 51% of new patient starts in Q1 2025 were reimbursed through pharmacy[11] - 71% of new patient starts in Q1 2025 came from multiple daily injections[30] 2025 Guidance - Full year 2025 total revenue is projected to be between $82 million and $87 million[18] - The company anticipates new patient starts through pharmacy to be 22-25% for the full year 2025[18] - Gross margin is expected to be 50-53% for the full year 2025[18] Strategic Highlights - The company raised approximately $206 million in net proceeds from its Initial Public Offering (IPO) in January 2025[15]