We are a commercial-stage medical device company engaged in the design, development and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. Diabetes is a serious, chronic and often lifelong condition with no known cure that is characterized by extended periods of elevated levels of glucose in the bloodstream, or hyperglycemia, resulting from the body’s inability to either produce or effectively utilize the hormone insulin. To treat their diabetes, PWD must undergo a rigorous regimen of daily insulin substitution, as elevated levels of glucose in the blood over time can lead to serious and often life-threatening cardiovascular, metabolic and nervous system complications. Despite decades of innovation that have advanced the quality of care available, a significant unmet need remains as the vast majority of PWD still cannot manage their diabetes effectively. Our product, the iLet Bionic Pancreas (iLet), is the first insulin delivery device cleared by the U.S. Food and Drug Administration (FDA) to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. We believe this marks a significant advancement over other insulin delivery technologies by offering a differentiated combination of improved glycemic control and a vastly simplified experience for users and caregivers. The iLet was specifically designed to provide improvements in glycemic control relative to currently available treatment options, such as insulin pumps, including partially automated insulin delivery (AID) systems (also known as hybrid closed-loop systems), and multiple daily injections (MDI), while also reducing the complexity and burden of achieving these improved results for PWD. It is enabled by adaptive closed-loop algorithms that continuously learn each person’s unique and ever-changing insulin requirements and then autonomously delivers the correct insulin doses every five minutes throughout the day and night. Only the user’s body weight is required for device initialization and the autonomous determination of all insulin doses, unlike insulin pumps and hybrid closed-loop systems, which require a complex host of parameters to configure. The adaptive closed-loop algorithms are designed to remove the need to manually adjust insulin pump therapy settings and variables required by conventional pump therapy and hybrid closed-loop systems, which both require the user to determine the size and timing of both meal and correction insulin doses and to adjust basal insulin dosing. Therefore, we believe the adaptive closed-loop algorithms can make the iLet easier to initiate and use on a daily basis than other available AID systems. We believe that the iLet represents one of the first significant advances in insulin delivery technology since the commercial availability of hybrid closed-loop systems began in 2017, and that its convenient product features, coupled with improved glycemic control, will appeal to broad segments of PWD who are seeking a simple path to improved disease management. Our initial commercialization efforts for the iLet are in type 1 diabetes (T1D), an indication for which we received FDA clearance in patients six and older in May 2023 in the United States. T1D is an autoimmune disorder that often develops during childhood or adolescence, but can occur at any age, and arises from a person’s immune system attacking and destroying the insulin-producing beta cells in the pancreas. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.8 million people with T1D currently in the United States, all of whom require daily insulin replacement to manage their disease. The average hemoglobin A1C (HbA1c), a measure of average blood-glucose (BG) levels over an extended period of time, among adults in the United States with T1D is 8.2%, and currently only about 20% of adults with T1D meet or exceed the American Diabetes Association (ADA) goal for HbA1c, which is 7.0% or lower. The remaining 80%, therefore, are at elevated risk of developing an array of potentially life-threatening complications that arise as a result of chronic exposure to hyperglycemia. We believe that one of the principal causes of these suboptimal outcomes is that the complexity of the user experience with most currently available insulin pumps and hybrid closed-loop systems has kept the majority of PWD from adopting them despite the improved disease management they can offer. These systems require PWD to set and to periodically adjust several insulin pump parameters, to quantify daily carbohydrate intake and to frequently calculate proper doses of insulin for their pump to deliver. We believe this complexity, and the constant engagement that is required in order to enjoy the full therapeutic benefits that these systems can offer, limits their uptake to a subset of PWD and to subspecialty healthcare providers (HCPs). We believe that approximately one-third of people with T1D in the United States utilize insulin pumps or hybrid closed-loop systems to receive their daily insulin, while the majority receive their daily insulin via MDI therapy, which is less complex, but often less effective and has been shown to be associated with higher HbA1c levels. This is based on our internal estimates factoring epidemiologic data from government and leading industry organizations such as the CDC, as well as industry sales data from public filings and disclosures made by the leading device manufacturers (Medtronic plc (Medtronic), Tandem Diabetes Care, Inc. (Tandem) and Insulet Corporation (Insulet), who collectively hold approximately 96% market share) and aggregated by third-party data service providers. Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population, as approximately 67% of the iLet’s adoption as of September 30, 2024 has come from PWD who were previously utilizing MDI. We were originally incorporated under the laws of the Commonwealth of Massachusetts in October 2015. In August 2024, we reincorporated under the laws of the State of Delaware. Our principal executive offices are located at 11 Hughes, Irvine, California.
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1. Imagine Nest (the smart thermostat company) for managing blood sugar levels in people with diabetes – an autonomous system that simplifies a complex daily task.
2. It's like Tesla's Full Self-Driving, but instead of navigating roads, it autonomously navigates a person's blood sugar levels for diabetes management.
3. Think of it as an intelligent personal assistant, like Amazon Alexa or Google Assistant, specifically designed to automate and simplify the complex daily management of diabetes.
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- iLet Bionic Pancreas System: An automated insulin delivery system designed to autonomously deliver insulin to manage blood glucose levels for people with type 1 diabetes.
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Beta Bionics (BBNX) develops and commercializes the iLet Bionic Pancreas System, a prescription-only automated insulin delivery system. While the company utilizes durable medical equipment (DME) suppliers and specialty pharmacies for distribution, its products are designed for and ultimately used by individual patients. Therefore, Beta Bionics primarily serves the following categories of individual customers:
- Individuals with Type 1 Diabetes: This primary customer group consists of patients aged 6 years and older who have Type 1 Diabetes and require continuous, automated insulin delivery to manage their blood glucose levels effectively.
- Individuals with Insulin-Requiring Type 2 Diabetes: This category includes patients aged 6 years and older who have Type 2 Diabetes and whose condition necessitates insulin therapy, benefiting from the automated insulin delivery capabilities of the iLet system.
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The major suppliers of Beta Bionics (BBNX) are:
- Flex Ltd. (FLEX)
- DexCom, Inc. (DXCM)
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Sean Saint, President, CEO & Board Member
Sean Saint is an engineer, entrepreneur, and diabetes technologist who also lives with type 1 diabetes. He founded Companion Medical, where he led the development and launch of the InPen system, the first FDA-cleared smart pen. Companion Medical was acquired by Medtronic in 2020. Before founding Companion Medical, Mr. Saint was an early employee at Dexcom and Tandem Diabetes Care. He also led the collaboration at Tandem Diabetes over 10 years ago to build the first wearable version of the bionic pancreas on a mobile device platform. He holds a Bachelor of Science degree in Mechanical Engineering from California Polytechnic State University – San Luis Obispo and is credited with over 175 issued and pending patent applications.
Stephen Feider, Chief Financial Officer, Treasurer & Secretary
Stephen Feider has extensive finance experience, primarily in healthcare-related companies. He joined Beta Bionics as Chief Financial Officer in August 2022. Prior to Beta Bionics, he served as Finance Director, Diabetes at Medtronic from September 2020 to August 2022. Before Medtronic, he was the Vice President of Finance at Companion Medical from April 2019 to September 2020; Companion Medical was acquired by Medtronic in 2020. Mr. Feider's background also includes serving as Corporate Controller at OurHealth (Marathon Health LLC) and working as a CPA at PwC. He earned both Bachelor's and Master's degrees in Accountancy from Butler University.
Steven Russell, MD, PhD, Chief Medical Officer
Dr. Steven Russell is an endocrinologist and diabetologist with almost 20 years of experience in diabetes management. He serves as an Associate Professor of Medicine at Harvard Medical School and an attending physician at Massachusetts General Hospital (MGH) Diabetes Associates. His research focuses on the application of new technologies to improve diabetes care. He was the principal clinical investigator in a collaboration with Boston University investigators to develop a wearable automated glucose control system, which is now licensed to Beta Bionics. Dr. Russell has directed approximately 20 bionic pancreas clinical trials, including inpatient and home-use studies. He received his PhD in biological chemistry and MD from the University of Texas Southwestern Medical Center.
Mark Hopman, R.Ph, MBA, Chief Commercial Officer
Mark Hopman serves as the Chief Commercial Officer for Beta Bionics. He holds both R.Ph. and MBA credentials.
Mike Mensinger, Chief Product Officer
Mike Mensinger is the Chief Product Officer at Beta Bionics.
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The key risks to Beta Bionics' business (BBNX) are:
- Lack of Profitability: Beta Bionics is currently unprofitable and faces significant operating losses, with no clear path to achieving profitability in the near term. This ongoing lack of profitability and reliance on strategic partnerships for commercialization are crucial factors for investors to consider.
- Intense Industry Competition: The company operates in a highly competitive diabetes device market, with established players such as Medtronic, Tandem Diabetes Care, Insulet Corporation, and DexCom. Beta Bionics believes its iLet algorithm is differentiated, but it must continuously monitor competitive product launches and advancements to maintain its market position. Concerns about market competitiveness have also arisen from previous sales guidance.
- Sales Force Ramp-Up and Market Momentum: Beta Bionics is significantly expanding its sales territories, and the time required for new sales representatives to reach full productivity is a factor to monitor. Previous sales guidance raised concerns about potential lost market momentum, indicating that effective sales force execution and market penetration are critical for the company's growth trajectory and ability to overcome operating losses.
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Large medical device competitors (e.g., Medtronic, Tandem Diabetes Care, Insulet) are continuously developing and improving their automated insulin delivery (AID) systems. Beta Bionics' iLet Bionic Pancreas differentiates itself through its unique simplicity, significantly reducing or eliminating the need for carb counting. A clear emerging threat is the potential for one of these well-capitalized competitors to launch a next-generation AID system that successfully integrates similar or superior ease-of-use (e.g., advanced algorithms that further simplify meal bolusing and reduce user input) while potentially offering additional advantages such as enhanced glycemic control, smaller device form factors, or broader integration with other digital health platforms. Such a development could directly diminish the iLet's core competitive advantage and market appeal.
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Beta Bionics (BBNX), a medical device company, primarily focuses on solutions to enhance the health and quality of life for individuals requiring insulin for diabetes. Their main product is the iLet Bionic Pancreas, an automated insulin delivery system specifically cleared for the treatment of Type 1 Diabetes (T1D) in adults and children aged six years and older. The company is also in the early stages of developing a patch pump and a bihormonal iLet, which would expand its reach to insulin-dependent Type 2 diabetes patients.
Addressable Markets:
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Type 1 Diabetes (T1D) Market:
- The global Type 1 Diabetes market size was valued at approximately USD 34.87 billion in 2024 and is projected to reach around USD 74.03 billion by 2034.
- The U.S. Type 1 Diabetes market size alone accounted for about USD 11.23 billion in 2024 and is anticipated to grow to approximately USD 24.27 billion by 2034.
- Across the seven major markets (7MM: US, EU4, UK, and Japan), the T1D market is expected to reach USD 9.9 billion by 2033, up from USD 2.2 billion in 2023. The U.S. market is projected to constitute the largest share, reaching USD 9.0 billion by 2033 within the 7MM.
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Automated Insulin Delivery (AID) Devices / Artificial Pancreas Device System Market:
- The global automated insulin delivery devices market size was valued at USD 3.29 billion in 2024 and is projected to reach USD 7.83 billion by 2032.
- The global artificial pancreas device system market size stands at USD 1.01 billion in 2025 and is forecast to reach USD 6.69 billion by 2030.
- Another report estimates the automated insulin delivery system market to expand from USD 901.04 million in 2024 to USD 1.94 billion by 2032.
- North America is expected to be a dominant region in the automated insulin delivery systems industry.
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Expected Drivers of Future Revenue Growth for Beta Bionics (BBNX)
Beta Bionics (BBNX) is positioned for future revenue growth over the next 2-3 years, driven by several key factors related to its flagship iLet Bionic Pancreas system and its innovation pipeline.
Here are the expected drivers:
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Continued Growth in iLet Bionic Pancreas Adoption and New Patient Starts: The iLet Bionic Pancreas is Beta Bionics' primary product, and its increasing adoption is a significant revenue driver. The company has reported substantial year-over-year growth in new patient starts and its installed customer base, indicating strong market penetration and demand for its automated insulin delivery system. This growth is anticipated to continue as the iLet system simplifies diabetes management for individuals with type 1 diabetes.
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Expansion of the Pharmacy Benefit Plan (PBP) Channel: The expansion of the Pharmacy Benefit Plan (PBP) channel is crucial for increasing access and affordability of the iLet system. This channel significantly reduces the upfront cost of the pump for both patients and health plans, while also easing administrative burdens for physicians. Beta Bionics has been actively expanding its formulary agreements with major Pharmacy Benefit Managers (PBMs) and has consistently raised its guidance for new patient starts through this high-margin recurring revenue channel.
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Innovation Pipeline with New Product Launches (Patch Pump, Bihormonal iLet): Beta Bionics' pipeline of innovative products is expected to drive future revenue growth. The company is actively developing the "Mint" Patch Pump, designed for direct skin adherence without tubing, and the Bihormonal iLet system, which aims to further enhance diabetes management. These next-generation devices are poised to disrupt the market and reinforce Beta Bionics' competitive edge, with ongoing trials for the bihormonal system.
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Geographic and Market Expansion: The company is focused on expanding its market reach, not only by penetrating new practices but also by potentially expanding into new patient populations, such as the Type 2 diabetes market. Beta Bionics' strategic hiring in sales supports this growth, indicating an ongoing effort to broaden its customer base and penetrate new sales territories.
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System Enhancements and Integrations: Ongoing software updates and integrations for the iLet Bionic Pancreas enhance its appeal and functionality. Recent examples include software updates that improve the cartridge change process and reduce redundant glucose alerts, as well as integration with other continuous glucose monitoring (CGM) systems like the FreeStyle Libre 3 Plus. These enhancements contribute to a better user experience and can attract new customers to the iLet platform.
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Share Issuance
- Beta Bionics completed an Initial Public Offering (IPO) in January 2025, raising approximately $212.1 million in gross proceeds.
- A concurrent private placement alongside the IPO generated an additional $17.0 million in gross proceeds from an existing investor.
Inbound Investments
- An existing investor, potentially Wellington Management, participated in a private placement contributing approximately $17.0 million in conjunction with the company's IPO in January 2025.
Outbound Investments
- Beta Bionics has strategically partnered with Xeris Pharmaceuticals, Inc. to develop a pump-compatible glucagon formulation.
- The company also collaborates with Abbott Diabetes Care Inc. to develop an advanced automated insulin delivery system.
Capital Expenditures
- Capital expenditures for the last 12 months amounted to -$3.96 million.
- The primary focus of capital and development efforts is on advancing its product pipeline, including a patch pump and a bihormonal iLet.
