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 ...

Beta Bionics (BBNX) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Blake Beber - Head - Investor RelationsSean Saint - Board Member, President & CEOStephen Feider - CFOMike Kratky - Senior Managing Director - Medical Devices & TechnologyMathew Blackman - Managing DirectorTravis Steed - Managing Director - Equity ResearchJeffrey Cohen - MD - Equity ResearchKelly L. Close - Founder & President Conference Call Participants Matt O'Brien - AnalystJeffrey Johnson - Senior Research AnalystBroo ...

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].

Financial Performance - Net sales for Q1 2025 were $17.6 million, a 36% increase from $12.9 million in Q1 2024[5] - The company reported a net loss of $28.7 million, or negative 162% of sales, compared to a net loss of $12.4 million, or negative 96% of sales in Q1 2024[5] - Adjusted EBITDA was negative $15.5 million, or negative 88% of sales, compared to negative $7.8 million, or negative 60% of sales in Q1 2024[5] - Total net sales for the three months ended March 31, 2025, were $17,639,000, representing a 36% increase from $12,933,000 in the same period of 2024[22] - The net loss for the three months ended March 31, 2025, was $28,656,000, compared to a net loss of $12,449,000 in Q1 2024[27] - Adjusted EBITDA for Q1 2025 was $(15,535,000), worsening from $(7,805,000) in Q1 2024[27] Sales Channels - Durable Medical Equipment (DME) channel net sales reached $13.8 million, up 14% from $12.1 million in Q1 2024[5] - Pharmacy Benefit Plan (PBP) channel net sales surged 360% to $3.8 million from $0.8 million in Q1 2024[5] - The DME channel total sales reached $13,827,000 in Q1 2025, up from $12,105,000 in Q1 2024[22] - The PBP channel total sales increased to $3,812,000 in Q1 2025, compared to $828,000 in Q1 2024[22] - The percentage of new patient starts reimbursed through the PBP channel rose to a low 20s percentage in March 2025, up from a mid-single digit percentage in March 2024[25] Customer Metrics - The installed customer base grew to 19,151 users, a 291% increase from 4,901 in Q1 2024[5] - New patient starts totaled 3,853, up 48% from 2,597 in Q1 2024[5] - New patient starts increased to 3,853 in Q1 2025, up 48% from 2,597 in Q1 2024[25] - The installed customer base grew significantly to 19,151 as of March 31, 2025, compared to 4,901 a year earlier[25] Financial Guidance and Projections - Full year 2025 revenue guidance was raised to approximately $82 million to $87 million, up from the previous estimate of $80 million to $85 million[11] - Estimated gross margin for 2025 is projected to be between 50% to 53%[11] Liabilities and Financial Position - Total liabilities, convertible preferred stock, and stockholders' deficit amounted to $338,024,000 as of March 31, 2025[20] - The change in fair value of warrant liabilities was $12,450,000 for Q1 2025, compared to $4,139,000 in Q1 2024[27] Cash Position - Cash and cash equivalents, along with short-term and long-term investments, totaled $295.5 million as of March 31, 2025[5]

IRVINE, Calif., May 06, 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 March 31, 2025 and raised its annual guidance for the year ending December 31, 2025. First Quarter 2025 Financial Results & Key Metrics Non-GAAP Financial Measures Beta Bionics, Inc. (the "Company") prepares and presents the Company's financial statements in accordance with U.S. General ...

Company Overview - Beta Bionics, Inc. is a commercial-stage medical device company focused on developing innovative solutions for insulin-requiring individuals with diabetes [3] - The company utilizes advanced adaptive closed-loop algorithms to enhance diabetes treatment and improve the health and quality of life for people with diabetes [3] - The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device that autonomously determines insulin doses, aiming to improve overall outcomes for a broad population of people with diabetes [3] Upcoming Event - Management will present at the Bank of America Securities Health Care Conference in Las Vegas on May 13, 2025, at 12:35 pm Eastern Time [1] - A live audio webcast of the presentation will be available on the company's website and archived for future replay [2]

Core Viewpoint - Beta Bionics, Inc. is set to release its first quarter 2025 financial results on May 6, 2025, after market close, followed by a conference call and webcast [1]. Company Overview - Beta Bionics, Inc. is a commercial-stage medical device company focused on developing innovative solutions for insulin-requiring individuals with diabetes [3]. - The company utilizes advanced adaptive closed-loop algorithms to enhance diabetes treatment, with its flagship product being the iLet Bionic Pancreas, the first FDA-cleared insulin delivery device that autonomously determines insulin doses [3]. Investor Relations - For investor inquiries, Blake Beber serves as the Head of Investor Relations, and can be contacted via email [4]. - Media and public relations are managed by Karen Hynes, Vice President of Marketing, who is also available for contact [4]. Webcast Information - The webcast for the financial results will be accessible on the company's website under the "Investors—Events & Presentations" section, and will be archived for future viewing [2]. - Live call access is available by dialing (888) 596-4144 with a passcode of 8363701 [2].

Beta Bionics (BBNX) Q4 2024 Earnings Call March 25, 2025 04:30 PM ET Company Participants Blake Beber - Head - Investor RelationsSean Saint - Board Member, President & CEOStephen Feider - CFOTravis Steed - Managing Director - Equity ResearchMike Kratky - Senior Managing Director - Medical Devices & TechnologyMathew Blackman - Managing DirectorJeffrey Cohen - MD - Equity Research Conference Call Participants Matt O'Brien - AnalystBrooks O'Neil - Senior Research Analyst Operator Good afternoon, and welcome to ...

Financial Performance and Risks - The company is pursuing a multi-channel DME and PBP coverage and reimbursement strategy to maximize access to the iLet within the T1D population, which may differentially impact financial results based on distribution channel fluctuations [337]. - For the year ended December 31, 2024, the top four DME distributors represented approximately 59% of total sales, indicating significant customer concentration risk [341]. - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments of $103.6 million, with net proceeds from the initial public offering and private placement totaling approximately $206 million [345]. - The company estimates that its funds will be sufficient to cover operating expenses and capital expenditures through the first half of 2028, based on current assumptions [345]. - The company relies solely on sales of the iLet and related single-use products for revenue, making it vulnerable to factors negatively impacting these sales [340]. - The total addressable market for the iLet may be smaller than anticipated, which could limit sales growth and profitability [358]. - The company may need to raise additional capital beyond the proceeds of its initial public offering, which could be challenging due to market conditions [347]. - The company faces risks related to supply chain disruptions that could affect product availability and sales [343]. - The reimbursement structure for the iLet may be influenced by competitors' approved devices, affecting financial performance [363]. - Demand for the iLet exceeded initial forecasts, leading to backorders, but these did not materially impact operational results [365]. - The company has increased inventory levels of the iLet to mitigate demand unpredictability, but failure to meet demand could harm customer relationships and revenue [365]. - The company faces intense competition from larger firms like Medtronic and Insulet, which have greater financial resources and established distribution networks [360]. - The company has limited marketing and sales capabilities, which may hinder revenue generation if not successfully expanded [371]. - The company faces risks related to pricing pressures and potential limitations on reimbursement rates due to healthcare reform measures [444]. Product Development and Regulatory Challenges - The company is focusing on the commercialization of its iLet automated insulin dosing system for the treatment of Type 1 Diabetes (T1D) in adults and children aged six and older [388]. - The company plans to expand the use of iLet to treat insulin-dependent Type 2 Diabetes (T2D) and pursue additional marketing authorizations for related conditions [388]. - The company is developing a bihormonal configuration of the iLet, which will require additional clinical trials and regulatory approvals [400]. - The company is in the early stages of developing a patch pump and intends to seek FDA clearance via a 510(k) submission [400]. - The company must maintain regulatory compliance and an acceptable safety profile to ensure continued acceptance of its products by patients, the medical community, and third-party payors [404]. - The regulatory authorization process is lengthy and unpredictable, with no guarantee of obtaining necessary marketing authorizations or clearances [406]. - The company is subject to potential enforcement actions if it fails to comply with FDA requirements, which could harm its business [410]. - The company is subject to ongoing regulatory obligations, and failure to comply could result in significant expenses and penalties, adversely affecting business operations [484]. - The FDA has granted clearance for the iLet for insulin-only delivery for the treatment of Type 1 Diabetes (T1D) in patients aged six years and older [408]. - A mandatory post-market surveillance order requires a one-year study with a sample size of 1,875 users to assess the safety and effectiveness of the iLet [403][405]. - The FDA has expressed concerns regarding the limited safety and effectiveness data for specific design features of the iLet, which may impact future marketing authorizations [403]. - The company plans to seek new marketing authorization for a bihormonal configuration of the iLet, which may require a more rigorous PMA process instead of the 510(k) pathway [409]. - The PMA process is generally more costly and uncertain, taking from one to three years or longer for approval, compared to the 510(k) clearance process which typically takes three to 12 months [407]. - Delays in clinical trials could materially affect development costs and delay marketing authorization for product modifications and candidates [412]. - Clinical trials may face delays or termination due to ambiguous or negative interim results, regulatory oversight, and reliance on third-party organizations for compliance [415]. - Safety concerns and adverse events during clinical trials could lead to suspension or discontinuation of trials, impacting marketing authorization and commercial viability [422]. - The company is developing the iLet in combination with other therapies, requiring FDA approval for a glucagon product, which is critical for the commercialization of the bihormonal configuration [425]. - The company has received clearance for the iLet to use with prefilled insulin cartridges, but faces risks of regulatory revocation or safety issues with existing therapies [426]. - The company is working to expand the compatibility of the iLet with other iCGM models, but faces risks if compatible devices encounter marketing authorization issues [428]. - The company intends to seek FDA approval for its glucagon product candidate through the 505(b)(2) regulatory pathway, but potential delays or complications could adversely affect its competitive position [429]. - Changes in FDA funding and personnel could hinder the timely review and authorization of new products, negatively impacting the company's business [431]. Manufacturing and Supply Chain - The company has limited experience in manufacturing and must ensure high-quality production to meet demand for its products [454]. - The company has experienced manufacturing issues related to screen breakage since launching the iLet in May 2023, prompting improvements in screen bonding and durability [457]. - The company relies on single source suppliers for critical components of the iLet, which poses risks of production delays and revenue loss if any supplier fails to deliver [462]. - The current lease for the manufacturing facility in Irvine, California, expires in May 2027, and failure to renew could involve significant relocation expenses and operational disruptions [460]. - The company has invested additional resources in hiring, training, and enhancing manufacturing processes following FDA clearance of the iLet, which may impact sales and operating margins if not managed properly [458]. - Manufacturing capacity needs to be increased to meet anticipated market demand, which introduces risks related to quality control and production capabilities [456]. - The complexity of the iLet's design may lead to undetected defects that could increase warranty costs and reduce revenue [469]. - The company is actively pursuing alternative suppliers for several existing components to mitigate risks associated with supplier dependency [466]. - Performance issues with shipping carriers could negatively affect the company's reputation and operational results, impacting customer relationships [476]. Legal and Compliance Issues - Compliance with healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, is critical, as violations could lead to significant penalties and operational restrictions [495]. - The company is subject to extensive data privacy and security obligations, including HIPAA, which imposes requirements for the protection and notification of breaches involving protected health information [506]. - Breaches of HIPAA could result in substantial civil, criminal, and administrative penalties, as well as additional oversight obligations [508]. - The company must report any breaches of unsecured protected health information to affected individuals and the U.S. Department of Health and Human Services within 60 days [507]. - The enforcement of healthcare laws is subject to rapid change, which could impact the company's business operations and compliance costs [500]. - The company is prohibited from marketing the iLet for off-label uses, which could lead to regulatory actions if promotional activities are deemed to promote such uses [493]. - The company must comply with Medicaid rebate requirements and other federal and state consumer protection laws in its pricing and rebate programs [498]. - Relationships with healthcare providers and third-party payors are subject to anti-kickback and fraud laws, which could expose the company to significant penalties and reputational harm [495]. - The California Consumer Privacy Act (CCPA) imposes specific requirements on businesses regarding consumer data, including potential fines for violations [511]. - The FTC has authority to enforce actions against entities engaging in unfair practices related to personal health information (PHI), with penalties for violations of the Health Breach Notification Rule (HBNR) [512]. - The company may face significant fines under the GDPR, with penalties up to €20 million or 4% of annual global revenue, whichever is greater [519]. - The company is subject to increasing scrutiny regarding the transfer of personal data from the EEA and UK to the United States, which may lead to operational disruptions if compliance is not met [522]. - The company may incur substantial costs and operational challenges due to evolving data privacy laws and regulations, necessitating changes to its services and systems [524]. - The company faces potential legal actions and significant statutory damages from privacy-related claims, which could adversely affect its financial condition [526]. - Compliance with the U.S. Foreign Corrupt Practices Act (FCPA) and similar laws is critical, as violations could result in fines and damage to the company's reputation [528]. - The company must navigate complex export controls and trade sanctions, which could hinder international sales and revenue generation [530]. - The use of AI/ML technologies may lead to regulatory fines and necessitate changes in business practices, impacting operational efficiency [514]. - The company is at risk of increased legal and compliance costs due to the evolving landscape of privacy laws, which may affect its ability to process personal data [525]. Intellectual Property and Competitive Landscape - The company relies on a combination of patents, trade secrets, copyrights, and other intellectual property rights to protect the iLet technology [531]. - The patent prosecution process is expensive and time-consuming, potentially hindering the ability to file necessary patent applications in a timely manner [532]. - The company does not have the first right to control the patent applications for technology in-licensed from BU and Xeris, which may affect enforcement [533]. - Trade secret protection and confidentiality agreements are utilized to safeguard proprietary know-how, but there is no guarantee against disclosure or independent development by competitors [534]. - The company maintains physical and electronic security measures to protect data and trade secrets, but breaches may occur, impacting competitive advantage [535]. - Failure to comply with obligations in intellectual property licenses could result in loss of rights critical to the business, particularly with BU and Xeris [536].