Summary of Beta Bionics Conference Call Company Overview - **Company**: Beta Bionics (NasdaqGM: BBNX) - **Event**: 2025 Conference on November 18, 2025 Key Points Industry and Market Position - Beta Bionics is experiencing growth in both starts and revenue, with a focus on the insulin pump market [3][4] - The company is competing in a highly competitive environment, particularly against a tubeless pump competitor [7][27] Product Differentiation and Success Factors - The iLet insulin pump has a unique design and algorithm that differentiates it from competitors, leading to commercial success [3][4] - Pharmacy reimbursement has exceeded expectations, generating approximately $450 per month in recurring revenue and facilitating easier prescriptions for doctors [4][5] - The ease of use of the iLet pump is a significant selling point, making it easier for patients to start and maintain their treatment [8][9][12] Clinical Outcomes - The clinical outcomes of the iLet are reported to be as good or better than other systems on the market, with significant improvements in patient A1C levels [9][28] - The company emphasizes the importance of patient lifestyle improvements alongside clinical outcomes, which are often prioritized by users [13] Prescriber Profile and Market Strategy - Ideal prescribers for the iLet are open-minded doctors who prioritize patient outcomes and are willing to adopt new technologies [16][17] - The sales strategy is data-driven, focusing on demonstrating the product's effectiveness through real-time data access for healthcare providers [19] Market Share and Growth Projections - Beta Bionics estimates capturing approximately 11% of new patient starts in the U.S. market, with potential for growth as the sales force expands [23] - The company aims to increase its territories from 63 to around 120 in the long term, with ongoing investments in sales coverage [25] Future Product Development - Beta Bionics is working on a patch pump, targeting commercialization by the end of 2027, with ongoing manufacturing and regulatory preparations [33][40] - The patch pump will be pharmacy-only, leveraging existing pharmacy reimbursement agreements to facilitate market entry [45][47] Regulatory and Compliance Updates - The company is addressing a remediation effort for approximately 34,000 cases, expected to be completed by June 2026 [66] - Ongoing communication with the FDA is in place, with updates provided every 45 days regarding compliance matters [64][66] Conclusion - Beta Bionics is positioned for growth in the insulin pump market, with a focus on product differentiation, ease of use, and strong clinical outcomes. The company is actively preparing for future product launches while managing regulatory compliance effectively.

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cambium Networks Corporation (CMBM) has seen a remarkable increase of 306%, trading at $2.51 [3] - Teradyne, Inc. (TER) is up 21%, currently priced at $176.00 [3] - Bloom Energy Corporation (BE) has risen by 18%, trading at $134.50 [3] - Jamf Holding Corp. (JAMF) is up 15%, with a price of $12.85 [3] - CSG Systems International, Inc. (CSGS) has increased by 14%, trading at $79.00 [3] - Olympic Steel, Inc. (ZEUS) is also up 14%, currently priced at $34.20 [3] - Beta Bionics, Inc. (BBNX) has risen by 12%, trading at $27.20 [3] - Sonim Technologies, Inc. (SONM) is up 10%, currently priced at $12.49 [3] - Canadian Solar Inc. (CSIQ) has increased by 9%, trading at $16.67 [3] - Interlink Electronics, Inc. (LINK) is also up 9%, currently priced at $6.85 [3] Premarket Losers - Stride, Inc. (LRN) has experienced a significant decline of 41%, trading at $89.44 [4] - Varonis Systems, Inc. (VRNS) is down 29%, currently priced at $44.71 [4] - Akebia Therapeutics, Inc. (AKBA) has decreased by 26%, trading at $2.26 [4] - Avantor, Inc. (AVTR) is down 17%, currently priced at $12.40 [4] - GlucoTrack, Inc. (GCTK) has seen a decline of 13%, trading at $6.29 [4] - Tigo Energy, Inc. (TYGO) is down 13%, currently priced at $2.20 [4] - Generac Holdings Inc. (GNRC) has decreased by 9%, trading at $172.00 [4] - Polar Power, Inc. (POLA) is down 8%, currently priced at $3.71 [4] - Caesars Entertainment, Inc. (CZR) has seen a decline of 7%, trading at $20.50 [4] - Anteris Technologies Global Corp. (AVR) is also down 7%, currently priced at $4.46 [4]

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]

Product Development and Innovation - The iLet is the first FDA-cleared insulin delivery device utilizing adaptive closed-loop algorithms, designed to autonomously determine insulin doses without requiring users to count carbohydrate intake [144]. - The company is developing a bihormonal system of the iLet that combines automated delivery of insulin and glucagon, with a recent clinical trial completed in September 2025 [158]. - The company intends to continue investing in disruptive technologies, including a patch pump and bihormonal system of the iLet, to maintain competitive positioning in the market [188]. - The company is pursuing a multi-channel coverage and reimbursement strategy to maximize access to the iLet, which includes working with payors to establish coverage under both DME and PBP channels [184]. Market Performance and Sales - For the nine months ended September 30, 2025, net sales increased to $68.1 million, up from $44.7 million for the same period in 2024, representing a growth of 52.4% [212]. - Net sales for Q3 2025 reached $27.3 million, a 63% increase from $16.7 million in Q3 2024, driven by higher sales of single-use products and growth in New Patient Starts [210]. - Single-use products accounted for 47% of net sales in Q3 2025, up from 27% in Q3 2024, indicating a significant increase in product adoption [210]. - The company experienced a shift in sales channels, with 79% of net sales generated through the DME channel and 21% through the PBP channel for the nine months ended September 30, 2025, compared to 91% and 9% in the prior year [213]. Financial Performance - Gross profit for Q3 2025 was $15.1 million, a 70% increase from $8.9 million in Q3 2024, highlighting improved profitability [208]. - The net loss for Q3 2025 was $14.2 million, a 46% increase from a net loss of $9.7 million in Q3 2024, indicating ongoing financial challenges [208]. - Total operating expenses for Q3 2025 were $32.2 million, a 62% increase from $19.9 million in Q3 2024, driven by higher research and development and sales and marketing expenses [208]. - Research and development expenses for the nine months ended September 30, 2025 were $24.7 million, an increase of 45% from $17.0 million in the same period in 2024 [220]. Customer Growth and Engagement - New Patient Starts increased to 5,334 in Q3 2025, compared to 3,180 in Q3 2024, reflecting a growing customer base [210]. - The installed customer base expanded, contributing to higher recurring sales of single-use products [237]. - The increase in new patient starts for the nine months ended September 30, 2025 was significant, rising to 14,121 from 8,910 in the same period in 2024 [212]. Strategic Partnerships and Collaborations - The company has established partnerships with Dexcom and Abbott to integrate the iLet with their continuous glucose monitoring systems [148]. - The company entered into a collaboration and license agreement with Xeris Pharmaceuticals, paying a one-time payment of $0.5 million and a milestone payment of $3.0 million for development milestones, with tiered royalties of low double-digit percentages based on net sales of glucagon products [170]. - The Device License Agreement with Boston University allows the company to market licensed products and meet certain diligence milestones, with regulatory milestones remaining [159][161]. Operational and Capital Management - The company plans to invest significantly in manufacturing capabilities and commercial infrastructure, with a 50,000 square foot facility in Irvine, California, expected to support anticipated clinical and commercial demand [187]. - Net cash used in operating activities was $42.3 million for the nine months ended September 30, 2025, compared to $34.0 million for the same period in 2024 [252]. - Net cash provided by financing activities was $213.8 million for the nine months ended September 30, 2025, primarily from IPO proceeds [257]. Regulatory and Compliance - The company is classified as an "emerging growth company," allowing it to take advantage of reduced reporting requirements under the JOBS Act [283]. - The company has elected to use an extended transition period for complying with new accounting standards, delaying adoption until they apply to private companies [284]. - The company qualifies as a "smaller reporting company" with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million [285].

Financial Performance - Net sales reached $27.3 million, a 63% increase from $16.7 million in Q3 2024[5] - Total net sales for the three months ended September 30, 2025, were $27,253,000, up 63.5% from $16,705,000 in the same period of 2024[23] - Durable Medical Equipment (DME) channel net sales were $21.0 million, up 45% from $14.5 million in Q3 2024[5] - Pharmacy Benefit Plan (PBP) channel net sales surged 178% to $6.2 million from $2.2 million in Q3 2024[5] - The company reported a significant increase in single-use product sales in the DME channel, rising to $6,840,000 in Q3 2025 from $3,420,000 in Q3 2024, a growth of 100%[23] Customer Growth - The installed customer base grew to 29,419 users, a 162% increase from 11,214 in Q3 2024[5] - New patient starts totaled 5,334, up 68% from 3,180 in Q3 2024[5] - New patient starts reached 5,334 in Q3 2025, a 67% increase from 3,180 in Q3 2024[25] - The installed customer base grew to 29,419 as of September 30, 2025, compared to 11,214 a year earlier, indicating a significant expansion[25] Profitability and Loss - The net loss was $14.2 million, or negative 52% of sales, compared to a net loss of $9.7 million or negative 58% of sales in Q3 2024[5] - Net loss for the three months ended September 30, 2025, was $14,209,000, compared to a loss of $9,736,000 in Q3 2024, reflecting a 46% increase in losses[27] - Adjusted EBITDA for the nine months ended September 30, 2025, was $(42,240,000), worsening from $(26,463,000) in the same period of 2024[28] Asset and Liability Management - Total assets increased to $330,046,000 as of September 30, 2025, compared to $149,645,000 on December 31, 2024, representing a growth of 120%[20] - Total current assets rose to $270,026,000 as of September 30, 2025, compared to $132,923,000 on December 31, 2024, marking a 103% increase[20] - Total liabilities decreased to $35,286,000 as of September 30, 2025, down from $73,632,000 at the end of 2024, a reduction of 52%[22] - Cash and cash equivalents increased to $38,485,000 as of September 30, 2025, from $30,432,000 at the end of 2024, a rise of 26%[20] Future Outlook - Full year 2025 revenue guidance raised to over $96.5 million, previously estimated at $88 million to $93 million[12] - Beta Bionics completed a glucagon pharmacokinetic-pharmacodynamic trial in Canada, supporting the development of its glucagon asset[5] - The company expects to initiate a feasibility trial in New Zealand for the bihormonal system by year-end 2025[12]

Core Insights - Beta Bionics, Inc. reported a significant increase in net sales and raised its full-year guidance for 2025, indicating strong growth in its diabetes management solutions [1][7]. Financial Performance - Net sales reached $27.3 million, a 63% increase from $16.7 million in Q3 2024 [5]. - Durable Medical Equipment (DME) channel net sales were $21.0 million, up 45% from $14.5 million in Q3 2024 [5]. - Pharmacy Benefit Plan (PBP) channel net sales surged 178% to $6.2 million from $2.2 million in Q3 2024 [5]. - Gross margin improved to 55.5%, up 212 basis points from 53.4% in Q3 2024 [5]. - The installed customer base grew to 29,419 users, a 162% increase from 11,214 in Q3 2024 [5]. - New patient starts totaled 5,334, a 68% increase from 3,180 in Q3 2024 [5]. - The company reported a loss from operations of $17.0 million, or negative 63% of sales, compared to a loss of $11.0 million or negative 66% of sales in Q3 2024 [5]. Strategic Developments - As of July 1, 2025, Beta Bionics has effective formulary agreements with all major pharmacy benefit managers in the U.S. [5]. - The completion of a glucagon pharmacokinetic-pharmacodynamic trial in Canada supports the development of the glucagon asset for the bihormonal system [5]. - A feasibility trial in New Zealand is expected to be initiated in Q4 2025 to test the bihormonal system in humans [5]. Full Year Guidance - The company estimates total revenue exceeding $96.5 million, up from a previous estimate of $88 million to $93 million [12]. - The expected percentage of new patient starts reimbursed through the PBP channel is revised to 27% to 29%, up from 25% to 28% [12]. - Estimated gross margin is now projected at 54% to 55%, an increase from the previous estimate of 52% to 55% [12].