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Beta Bionics Inc(BBNX) - 2025 Q2 - Quarterly Results
2025-07-29 20:04
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 ...
Beta Bionics Reports Second Quarter 2025 Financial Results and Raises Full Year 2025 Guidance
Globenewswire· 2025-07-29 20:02
Core Viewpoint - Beta Bionics, Inc. reported strong financial results for Q2 2025, with significant growth in net sales and an increase in its full-year guidance for 2025 [1][2]. Financial Results - Net sales reached $23.2 million, a 54% increase from $15.0 million in Q2 2024 [5]. - Durable Medical Equipment (DME) channel net sales were $18.6 million, up 31% from $14.3 million in Q2 2024 [5]. - Pharmacy Benefit Plan (PBP) channel net sales surged to $4.6 million, a 498% increase from $0.8 million in Q2 2024 [5]. - Gross margin improved to 53.8%, up from 53.7% in Q2 2024 [5]. - The installed customer base grew to 24,085 users, a 200% increase from 8,034 in Q2 2024 [5]. - New patient starts totaled 4,934, a 57% increase from 3,133 in Q2 2024 [5]. - The company reported a loss from operations of $19.9 million, or negative 86% of sales, compared to a loss of $11.8 million or negative 78% of sales in Q2 2024 [5]. - Net loss was $16.9 million, or negative 73% of sales, compared to a net loss of $14.5 million or negative 96% of sales in Q2 2024 [5]. Strategic Highlights - The company hosted its first investor and analyst event on June 22, 2025, during the American Diabetes Association's 85 Scientific Sessions [5]. - Beta Bionics announced "Mint" as the brand name for its developing patch pump and demonstrated its key features [5]. - As of July 1, 2025, the company has effective formulary agreements with all major pharmacy benefit managers in the U.S. [5]. - The company completed dosing for a glucagon pharmacokinetic-pharmacodynamic bridging trial in Canada, which is expected to inform future development strategies [5][6]. Full Year Guidance - Beta Bionics raised its full-year revenue guidance to an estimated $88 million to $93 million, up from the previous estimate of $82 million to $87 million [11]. - The company expects 25% to 28% of new patient starts to be reimbursed through the PBP channel, an increase from the previous estimate of 22% to 25% [11]. - Estimated gross margin for the year is now projected to be between 52% and 55%, up from the previous range of 50% to 53% [11].
Beta Bionics to Announce Second Quarter 2025 Financial Results on July 29, 2025
GlobeNewswire· 2025-07-02 11:30
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]
BBNX Stock May Gain From Abbott Deal to Advance iLet Integration
ZACKS· 2025-06-23 16:21
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].
Beta Bionics (BBNX) Update / Briefing Transcript
2025-06-22 13:00
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.
Beta Bionics Announces Agreement with Abbott to Integrate the iLet Bionic Pancreas with Abbott's Future Dual Glucose-Ketone Sensor
Globenewswire· 2025-06-19 11:00
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]
Beta Bionics (BBNX) 2025 Conference Transcript
2025-05-13 17:35
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]
Beta Bionics Inc(BBNX) - 2025 Q1 - Earnings Call Presentation
2025-05-07 04:54
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]
Beta Bionics Inc(BBNX) - 2025 Q1 - Earnings Call Transcript
2025-05-06 21:30
Financial Data and Key Metrics Changes - Beta Bionics reported net sales of $17.6 million for Q1 2025, representing a 36% year-over-year growth [10] - The gross margin for Q1 2025 was 50.9%, down from 55.7% in Q1 2024, primarily due to an increase in new patient starts through the pharmacy channel [11][17] - Operating expenses increased by 66% to $27.6 million compared to $16.7 million in Q1 2024, mainly due to the expansion of the field sales team and costs associated with being a public company [18] Business Line Data and Key Metrics Changes - The company saw 3,853 new patient starts in Q1 2025, up 48% year-over-year, with a low 20s percentage of these starts reimbursed through the pharmacy channel, significantly higher than the mid-single digits in Q1 2024 [10][11] - Approximately 71% of new patient starts in Q1 came from individuals who previously used multiple daily injections, indicating the islet is addressing an unmet need in the market [15] Market Data and Key Metrics Changes - The pharmacy channel is preferred for reimbursement as it lowers out-of-pocket costs for patients and is financially accretive over a four-year period compared to the DME channel [16] - The company anticipates that the percentage of new patient starts reimbursed through the pharmacy channel will remain strong in Q2 2025, with continued growth expected in the latter half of the year [22] Company Strategy and Development Direction - Beta Bionics is focused on building a differentiated company with innovative products, including an adaptive closed-loop algorithm and a pay-as-you-go pharmacy model [8][9] - The company is increasing its annual guidance for 2025, projecting net sales of $82 million to $87 million, up from previous guidance of $80 million to $85 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting or exceeding updated projections for the remainder of the year, driven by robust demand for the islet and the success of recent product launches [9][10] - The management team believes that the pharmacy model, while presenting short-term headwinds, will yield long-term benefits and customer value [12][14] Other Important Information - The company is progressing on its innovation pipeline, including a patch pump expected to launch by the end of 2027 and a bihormonal pump program [31][32] - Beta Bionics is also working on a healthcare provider portal to enhance communication and collaboration between providers and islet users [33] Q&A Session Summary Question: Insights on the pharmacy channel dynamics and outlook - Management noted that the increase in pharmacy reimbursement success is due to faster adoption by health plans, particularly following the Prime Therapeutics contract [39][40] - The company expects to sustain the pharmacy reimbursement percentage seen in Q1 throughout the year, with slight increases anticipated [41] Question: New patient starts and sales force impact - The company experienced a 4% reduction in new patient starts from Q4 to Q1, which is less than expected for the seasonally weaker quarter, attributed to new product launches and a maturing sales force [45][46] Question: Guidance assumptions and competitive landscape - The new guidance reflects an increase in new patient starts expectations, which is higher than the revenue guidance due to the pharmacy model's impact [52] - Management remains aware of competitive pressures but believes the islet's unique algorithm provides a strong market position [54][55] Question: Type 2 diabetes traction and prescriber engagement - Management indicated that a significant portion of type 2 patients is managed in primary care, which presents unique challenges and opportunities for the islet [57] Question: Patch pump progress and revenue modeling - The company reiterated its timeline for the patch pump's commercial launch and noted that revenue per patient in the DME side saw a decline due to inventory dynamics [90][93]
Beta Bionics Inc(BBNX) - 2025 Q1 - Quarterly Report
2025-05-06 20:20
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 [135]. - The company is developing a bihormonal configuration of the iLet that combines automated delivery of insulin and glucagon, with a clinical trial for the glucagon product candidate initiated in March 2025 [151]. - The company intends to pursue the development of new diabetes devices and treatments, including a patch pump and bihormonal configuration of the iLet [177]. - The company entered into a collaboration and license agreement with Xeris Pharmaceuticals, Inc. to develop and commercialize glucagon products, with a one-time payment of $0.5 million and a milestone payment of $3.0 million for development milestones [162]. - The company ordered $0.9 million in clinical material for Phase 2 clinical trials, with a remaining payment of $0.6 million made in March 2025 [243]. - Future product offerings include the patch pump and bihormonal configuration of the iLet, with ongoing research and development efforts [244]. Market Adoption and Sales Performance - Approximately 1.8 million people in the U.S. have type 1 diabetes (T1D), with an estimated one-third using insulin pumps or hybrid closed-loop systems, while the majority rely on multiple daily injections (MDI) [137]. - As of March 31, 2025, approximately 71% of iLet adoption came from users previously utilizing MDI, indicating strong market resonance [138]. - The installed customer base grew to 19,151 in Q1 2025, up from 4,901 in Q1 2024, indicating strong market adoption [226]. - New patient starts reached 3,853 in Q1 2025, compared to 2,597 in Q1 2024, reflecting a growth in user adoption [226]. - The company plans to grow sales by expanding marketing initiatives and partnerships, focusing on the T1D population treated by primary care physicians [172]. Financial Performance - Net sales for Q1 2025 were $17.6 million, a 36% increase from $12.9 million in Q1 2024, driven by higher sales of single-use products [199]. - Cost of sales increased by 51% to $8.7 million in Q1 2025 from $5.7 million in Q1 2024, primarily due to higher sales volume of single-use products [202]. - Gross profit for Q1 2025 was $9.0 million, a 25% increase from $7.2 million in Q1 2024, with a gross margin of 51%, down from 56% in the prior year [203]. - The net loss for Q1 2025 was $28.7 million, a 100% increase from a net loss of $12.4 million in Q1 2024 [199]. - Total other expense, net was $10.0 million for Q1 2025, up from $3.0 million in Q1 2024, reflecting a 233% increase [208]. - Adjusted EBITDA for Q1 2025 was $(15.5) million, worsening from $(11.3) million in Q4 2024 [215]. Expenses and Cost Management - Research and development expenses rose by 39% to $7.6 million in Q1 2025, compared to $5.5 million in Q1 2024, mainly due to increased engineering and clinical trial costs [204]. - Sales and marketing expenses surged by 75% to $13.4 million in Q1 2025, up from $7.7 million in Q1 2024, reflecting efforts to drive awareness and adoption of the iLet [199]. - General and administrative expenses increased by 89% to $6.6 million in Q1 2025, compared to $3.5 million in Q1 2024, due to costs associated with operating as a public company [193]. - The company anticipates costs associated with scaling manufacturing capacity and expanding sales and marketing efforts, both domestically and internationally [244]. Revenue Recognition and Accounting - Revenue is recognized when control of goods is transferred to customers, with variable consideration related to pharmacy rebates and chargebacks impacting reported revenue [249]. - The company recognizes revenue related to mobile application access and firmware upgrades ratably over a four-year warranty period [250]. - Stock-based compensation expense is recognized over the requisite service period, with fair value determined using the Black-Scholes option pricing model [251]. Strategic Partnerships and Collaborations - The company has partnered with Dexcom and Abbott to integrate the iLet with their continuous glucose monitoring systems, enhancing the user experience [139]. - The Device License Agreement with Boston University allows the company to market licensed products and meet regulatory milestones, ensuring continued innovation in diabetes management [152]. - The company issued 1,140 shares of Class B common stock to Boston University (BU) as part of the Control Algorithm License Agreement, representing a specified ownership percentage on a fully diluted basis [157]. - The company is required to pay BU quarterly royalties of a mid-single-digit percentage based on net sales and a low double-digit percentage based on net sales by sublicensees [157]. Liquidity and Funding - Cash, cash equivalents, and investments totaled $295.5 million as of March 31, 2025, providing a solid liquidity position [232]. - Net cash used in operating activities was $19.975 million in Q1 2025, primarily due to a net loss of $28.7 million [234]. - Net cash provided by financing activities was $211.1 million in Q1 2025, mainly from IPO proceeds [238]. - Company expects to fund operations through product revenue and potential equity or debt financing, with existing resources projected to cover expenses through the first half of 2028 [240]. Regulatory and Reporting Status - The company is classified as an "emerging growth company," allowing for reduced reporting requirements and an extended transition period for new accounting standards [263][264]. - 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 [265]. - The company may continue to be classified as a smaller reporting company even after it ceases to be an emerging growth company [265]. - The company has reduced disclosure obligations regarding executive compensation as a smaller reporting company [265].