Beta Bionics (BBNX) Q2 2025 Earnings Call July 29, 2025 04:30 PM ET Speaker0Good afternoon, and welcome to the Beta Bionics Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session and instructions will follow at that time. As a reminder, please be advised that today's conference is being recorded. I would now like to turn the conference over to Blake Beaver, Head of Inv ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-42491 BETA BIONICS, INC. (Exact name of Registrant as specified in its charter) Delaware 47-5386878 (State or other jurisdiction ...

EXHIBIT 99.1 Beta Bionics Reports Second Quarter 2025 Financial Results and Raises Full Year 2025 Guidance IRVINE, Calif., July 29, 2025 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management solutions, today reported its financial results for the quarter ended June 30, 2025 and raised its full year guidance for the year ending December 31, 2025. Second Quarter 2025 Financial Results & Key Metrics See "Non-GAAP Financial Measures" below ...

Company Announcement - Beta Bionics, Inc. plans to release its second quarter 2025 financial results after the market closes on July 29, 2025 [1] - A conference call and webcast will be hosted on the same day at 4:30 pm Eastern Time [1] Webcast Information - The link to the webcast will be available on the company's website in the "Investors—Events & Presentations" section and will be archived for future replay [2] - A personal pin and dial-in details for the live call can be accessed through a provided registration link [2] Company Overview - Beta Bionics is a commercial-stage medical device company focused on developing innovative solutions for insulin-requiring individuals with diabetes [3] - The iLet Bionic Pancreas is highlighted as the first FDA-cleared insulin delivery device that autonomously determines insulin doses, aiming to improve health outcomes for people with diabetes [3]

Company Overview - Beta Bionics, Inc. (BBNX) has entered a strategic agreement with Abbott Laboratories (ABT) to integrate its iLet Bionic Pancreas automated insulin delivery (AID) system with Abbott's upcoming dual glucose-ketone sensor in the U.S. This integration aims to enhance the functionality of the iLet system, providing comprehensive metabolic monitoring and simplifying diabetes care for patients [1][6]. Collaboration Details - The partnership combines Beta Bionics' AI-driven insulin dosing technology with Abbott's expertise in continuous glucose monitoring, potentially expanding access to innovative AID solutions. This alignment with Abbott's next-generation sensor platform positions BBNX to improve patient outcomes and strengthen its competitive edge in the diabetes tech landscape [2][4]. Market Position and Financials - BBNX currently has a market capitalization of $775.6 million. The Zacks Consensus Estimate for fiscal 2025 revenues is projected at $84.91 million, indicating a growth of 30.4% from the fiscal 2024 reported number [5]. In the year-to-date period, BBNX shares have lost 24.3%, while the industry has declined by 12% [3]. Product Efficacy - The iLet Bionic Pancreas is a fully automated insulin delivery system that simplifies diabetes management through a closed-loop algorithm. It adjusts doses every five minutes based on real-time continuous glucose monitoring (CGM) data, allowing users to announce meal sizes instead of counting carbs [7]. In a pivotal trial with 440 participants, the iLet reduced HbA1c by up to 0.7% and increased time-in-range by 2.6 hours per day without raising hypoglycemia risk [8]. Industry Prospects - The global automated insulin delivery devices market was valued at $3.29 billion in 2024 and is projected to reach $7.83 billion by 2032, with a compound annual growth rate (CAGR) of 11.43%. This growth is driven by the rising prevalence of diabetes and advancements in technology, indicating a favorable market environment for BBNX's latest deal with Abbott [10].

Summary of Beta Bionics (BBNX) Investor and Analyst Event - June 22, 2025 Company Overview - **Company**: Beta Bionics (BBNX) - **Event Type**: Investor and Analyst Event - **Date**: June 22, 2025 - **Key Speakers**: Sean Sain (CEO), Steven Fajder (CFO), Mark Hottman (Chief Commercial Officer), Doctor Steven Russell (Chief Medical Officer) Core Industry and Product Insights - **Industry**: Diabetes management technology - **Product Highlight**: Islet, an adaptive closed-loop insulin delivery system - **New Product Launch**: Bionic Portal, an online healthcare provider portal for clinical data access [9][10][12] Key Points and Arguments 1. **Bionic Portal Launch**: - Aimed at enhancing accessibility of clinical outcomes data for healthcare providers [10][12] - Utilizes real-world patient data to demonstrate improvements in A1C levels [11][13] 2. **Pharmacy Business Model**: - Beta Bionics aims to replicate successful strategies from previous roles of the Chief Commercial Officer in establishing pharmacy sales [14][16] - New patient starts guidance raised to 22-25% for the year [16] 3. **User Experience and Cost**: - Patients face lower out-of-pocket costs, averaging $300 per year for the product, compared to thousands for traditional pump therapies [22][24] - No long-term commitment ("pump jail") for patients, allowing flexibility in switching providers [23][25] 4. **Algorithm Differentiation**: - Discussion on the differences between hybrid and fully closed-loop systems, emphasizing the need for user engagement in hybrid systems [31][32] - Beta Bionics positions Islet as a leading adaptive closed-loop system, reducing the need for manual input from users [56][58] 5. **Clinical Outcomes**: - Average baseline A1C for Islet users is 8.9%, with a reduction to 7.3% after use, demonstrating significant efficacy [67][70] - The system adapts automatically to user needs, providing real-time adjustments to insulin delivery [68][69] 6. **Market Opportunity**: - Over 50% of Type 1 diabetes patients in the U.S. are managed by primary care providers, presenting a significant market opportunity for Islet [78] - The potential to reach patients who struggle with traditional management methods due to the automation of the Islet system [72][73] 7. **Patch Pump Development**: - Introduction of the Mint patch pump, designed to minimize user burden and enhance convenience [92][94] - The Mint system will feature a reusable controller and disposable cartridge, with no need for charging [95][96] Additional Important Insights - **User-Centric Design Philosophy**: The company emphasizes reducing the burden of diabetes management through innovative product design [88][89] - **Patient Testimonials**: Positive feedback from users, including a notable case of an eight-year-old girl who felt she could forget about her diabetes while using Islet [91] - **Hypoglycemia Rates**: Low rates of hypoglycemia reported among users, indicating safety and effectiveness of the system [84] This summary encapsulates the key points discussed during the Beta Bionics investor and analyst event, highlighting the company's innovative approach to diabetes management and the potential impact of its products on patient care and market dynamics.

Core Insights - Beta Bionics, Inc. plans to integrate its iLet Bionic Pancreas automated insulin delivery system with Abbott's upcoming dual glucose-ketone sensor in the U.S. market [1][2][3] Company Overview - Beta Bionics is a commercial-stage medical technology company focused on simplifying diabetes management and improving outcomes for individuals requiring insulin therapy [3] - The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device featuring a fully autonomous insulin dosing algorithm, setting a new standard in diabetes care [3] Product Features - The iLet system is the first and only automated insulin delivery system that makes 100% of insulin dosing decisions automatically, allowing users to achieve excellent clinical outcomes without the need for carb counting or manual insulin correction calculations [2] - Currently, the iLet supports Abbott's FreeStyle Libre® 3 Plus continuous glucose monitoring sensor, and the future integration with Abbott's dual glucose-ketone sensor is expected to enhance real-time decision-making support for diabetes management [2][3]

Summary of Beta Bionics Conference Call Company Overview - **Company**: Beta Bionics - **Event**: Bank of America Health Care Conference - **Key Executives**: CEO Sean Saint, CFO Steven Fighter Financial Performance - **Q1 Performance**: Achieved a 9% revenue beat with new patient starts exceeding expectations by approximately 450 patients [4][5] - **Pharmacy Adoption**: New patient starts through pharmacy exceeded guidance, achieving a low twenties percentage in Q1, prompting an increase in annual guidance for pharmacy reimbursement [5][6] Product Developments - **Islet Insulin Pump**: Positioned as a fundamentally different option in insulin pumps, focusing on patient experience rather than just clinical outcomes [11][12] - **New Product Launches**: Introduced several products including Libre three, Color Eyelet, and Bionic Circle app, which are gaining traction in the market [15][17] - **Salesforce Productivity**: The productivity of the salesforce is evolving, with a focus on demonstrating patient outcomes to prescribing doctors [18][19] Market Dynamics - **Territory Expansion**: Expanded to 63 territories, with 20 new territories added in Q1 2025, although these had no significant revenue impact in Q1 [24][30] - **Patient Demographics**: Noted an increase in type 2 diabetes patients, with 20-25% of new patients in Q1 coming from this demographic [36] Revenue Guidance - **Updated Revenue Guidance**: Raised revenue expectations to between $82 million and $87 million for the year, influenced by increased pharmacy adoption and new patient starts [31][35] - **Gross Margin Guidance**: Increased gross margin guidance to 50-53%, attributed to scale benefits and reduced bill of materials costs [38][39] Pharmacy Channel Insights - **Pharmacy Benefits**: The pharmacy channel reduces upfront costs for patients, facilitating easier access to the islet pump, which is expected to drive new patient starts [35][37] - **PBM Contracts**: The process for securing pharmacy benefit manager (PBM) contracts is crucial for adoption, involving discussions with health plans and logistical considerations for fulfilling prescriptions [44][49] Future Developments - **Patch Pump**: Anticipated commercialization by the end of 2027, with a demonstration planned at the upcoming ADA event [50][52] Additional Considerations - **Tariff Impact**: Minimal impact from tariffs on components sourced from China, as most custom components are exempt from tariffs [43]

Q1 2025 Earnings May 6, 2025 Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Beta Bionics, Inc. (the "Company") regarding our regulatory development plans for the iLet and other product candidates; the markets and ...