IRVINE, Calif., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management solutions, today announced that it plans to release its third quarter 2025 financial results after the financial markets close on Tuesday, October 28, 2025. Management will host a conference call and concurrent webcast on the same day at 4:30 pm Eastern Time (1:30 pm Pacific Time). The link to the webcast will be available on the Company’s website in the ...

Company Highlights - Aurinia Pharmaceuticals Inc. (AUPH) has seen solid growth for its product LUPKYNIS, with expected net product sales for 2025 ranging from $250 million to $260 million, up from $216.2 million last year [2][3] - Arrowhead Pharmaceuticals Inc. (ARWR) is preparing for its first commercial launch in 2025, with its lead drug candidate Plozasiran under FDA review, decision expected on November 18, 2025 [4][5] - Beta Bionics Inc. (BBNX) reported a 54% growth in second-quarter net sales, with expectations for full-year 2025 net sales to range between $88 million and $93 million, compared to $65.1 million last year [7][8] - Kiniksa Pharmaceuticals International plc (KNSA) anticipates net product revenue for its drug Arcalyst to be between $625 million and $640 million for 2025, up from $417 million in 2024 [10][11] - Ionis Pharmaceuticals Inc. (IONS) generated net product sales of $19 million in Q2 2025, with a supplemental new drug application expected by year-end [12][14] - Stoke Therapeutics Inc. (STOK) is developing Zorevunersen for Dravet syndrome, with a 52-week high of $24.60 reached recently, representing an 82% gain in less than two months [16][17] - Fortress Biotech Inc. (FBIO) is awaiting an FDA decision on its investigational drug CUTX-101 for Menkes disease, expected on September 30, 2025 [18][21] Stock Performance - AUPH stock increased by 168% over 1.5 years, reaching a 52-week high of $12.87 [3] - ARWR stock gained 65% in less than 9 months, hitting a 52-week high of $31.13 [5] - BBNX stock rose nearly 55% in less than 4 months, reaching a 52-week high of $26.66 [8] - KNSA stock saw a 46% increase in less than four months, touching a 52-week high of $37.34 [11] - IONS stock gained 52% in less than two months, reaching a 52-week high of $64.72 [15] - STOK stock increased by 82% in less than two months, achieving a 52-week high of $24.60 [17] - FBIO stock rose by 61% in less than a month, reaching a 52-week high of $3.97 [21]

Core Points - The conference call is focused on the recent announcement regarding the EchoStar contract update [2] - Key executives participating in the call include the CEO, CFO, and VP of Satellite Systems [2] Financial Performance - The call may include references to non-IFRS financial measures, which are believed to provide useful supplemental information about financial performance [4]

Company Overview - Beta Bionics is positioned as an automated insulin delivery system, referred to as a "bionic pancreas" to differentiate it from traditional insulin pumps [2][3] - The company emphasizes its advanced automation features, which enhance user simplicity and reduce the need for manual boluses [2] Industry Insights - The insulin delivery market is evolving with a focus on automation and user-friendly technology, moving towards adaptive algorithms that minimize healthcare provider involvement [3]

Summary of Beta Bionics FY Conference Call Company Overview - **Company**: Beta Bionics (NasdaqGM: BBNX) - **Product**: Automated insulin delivery system referred to as the "Bionic Pancreas" rather than an insulin pump [5][6] Industry Insights - **Insulin Pump Market**: The insulin pump industry has not significantly improved diabetes outcomes on a population level, as evidenced by stagnant average A1C levels [6][7] - **Current Penetration**: Approximately 40% of type 1 diabetes patients in the U.S. use insulin pumps, indicating room for growth [8] Key Differentiators - **Adaptive Algorithm**: Beta Bionics' product features an adaptive algorithm that simplifies management, allowing primary care physicians to handle the setup and management of the pump [5][10] - **Clinical Trial Data**: Clinical trials show that outcomes with the Bionic Pancreas are comparable between primary care providers and endocrinologists, which is unprecedented [10] Market Challenges - **Primary Care Provider Engagement**: A significant barrier to pump adoption is the lack of familiarity and comfort among primary care providers in managing insulin pumps [9][11] - **Patient Trust**: Some patients may be hesitant to trust automated systems, particularly those who have managed their diabetes for a long time [15][16] Competitive Landscape - **Continuous Glucose Monitors (CGMs)**: CGMs have achieved over 80% penetration in type 1 diabetes, highlighting the need for insulin pumps to simplify their usage to achieve similar success [12][13] - **Type 2 Diabetes Market**: While Beta Bionics does not market directly to type 2 diabetes patients, over 25% of their users are from this demographic, indicating a growing interest [20][22] Product Features - **User Experience**: The Bionic Pancreas is designed for ease of use, with a two-part durable disposable product that minimizes user interaction with the device [32][33] - **Cost Structure**: The product's design allows for higher gross margins compared to competitors, as it separates durable and disposable components [35] Innovation and Development - **Speed of Innovation**: The company emphasizes maintaining a fast-paced, agile approach to product development, which is seen as a competitive advantage [36][39] - **Bihormonal System Potential**: Beta Bionics has licensed a shelf-stable glucagon for a bihormonal system, which could enhance diabetes management by addressing both highs and lows [71][72] Regulatory and Market Dynamics - **Rental Model**: The shift towards a rental model for insulin pumps is viewed positively, as it allows for quicker access to innovations for patients [58][59] - **Competitive Bidding**: Concerns about competitive bidding in the DME space are noted, but the company believes it can navigate these challenges effectively [62][63] Conclusion - **Future Outlook**: Beta Bionics is positioned to capitalize on the growing demand for innovative diabetes management solutions, with a focus on improving patient outcomes and expanding market penetration through strategic partnerships and product development [70][72]

If you like to see more ideas, please subscribe to the premium service "Value in Corporate Events" here and try the free trial. In this service we cover major earnings events, M&A, IPOs, and other significant corporate events with actionable ideas. Furthermore, we provide coverage of situations and names on request!Shares of Beta Bionics, Inc. ( NASDAQ: BBNX ) have come to life again as shares have recovered towards the $20 mark. In April, I wondered if the company was really slowing down or whether managem ...

Financial Data and Key Metrics Changes - The company raised its full-year revenue guidance, implying a year-over-year growth of 27% to 40%, following a 45% growth in the first half of the year [13][14] - The financial position is strong, with ample cash reserves to support operations and R&D projects, indicating no financing risk [11][12] Business Line Data and Key Metrics Changes - The pharmacy channel has been a significant driver of growth, with guidance for pharmacy reimbursement increasing from 20% to 25%-28% [22][24] - New patient starts in the pharmacy channel were reported at a high 20% in the most recent quarter, reflecting successful PBM and health plan contracts [25] Market Data and Key Metrics Changes - The company captured approximately 10.5% to 11% of new patient starts in the insulin pump market during the second quarter [20] - There is a notable increase in type 2 diabetes patients adopting the product, with over 25% of new starts in the second quarter being type 2 patients [10][21] Company Strategy and Development Direction - The company aims to shift as many patients as possible to the pharmacy channel, which offers lower out-of-pocket costs for patients and higher margins for the company [24] - The long-term goal is to have all products reimbursed through the pharmacy channel, enhancing accessibility and affordability [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's market position and the continued ramp-up in new patient starts, driven by pharmacy adoption and positive clinical results [14][15] - The emergence of a new competitor, Sequel, is acknowledged, but management does not foresee significant headwinds from this competition [16][34] Other Important Information - The company is pursuing a label for type 2 diabetes but does not believe it is necessary for current prescriptions [27] - The Mint product is in development, with plans for a commercial launch by the end of 2027 [71] Q&A Session Summary Question: Why is growth expected to decelerate in the second half of the year? - Management indicated that the first half of 2025 was strong, and they want to set realistic expectations for the second half, while pharmacy uptake continues to exceed expectations [14][15] Question: What is driving the acceleration of the pharmacy channel? - The acceleration is attributed to winning PBM contracts and underlying health plan contracts faster than expected, making it easier for patients to access the product [24][25] Question: What is the plan for obtaining a label for type 2 diabetes? - The company intends to pursue a label but does not believe it is necessary for current prescriptions, and specifics on the regulatory pathway were not disclosed [27][30] Question: How does the company view competition from Sequel? - Management respects Sequel's product but does not see it as a direct competitor, noting that their product offers a low-touch solution compared to Sequel's high-touch approach [16][34] Question: What are the long-term goals for gross margin? - Management highlighted three tailwinds for gross margin improvement, including cost-effective manufacturing, higher pricing in the pharmacy channel, and the Mint product's expected higher margins [79][80]

Company Overview - Beta Bionics, Inc. is a commercial-stage medical device company focused on developing innovative solutions for insulin-requiring individuals with diabetes [2] - The company utilizes advanced adaptive closed-loop algorithms to enhance diabetes treatment and improve the health and quality of life for people with diabetes [2] - 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 [2] Upcoming Events - Beta Bionics will present at three investor conferences: Wells Fargo Annual Healthcare Conference on September 4, 2025, Morgan Stanley Annual Global Healthcare Conference on September 8, 2025, and Baird 2025 Global Healthcare Conference on September 10, 2025 [4] - Presentations at the Wells Fargo and Morgan Stanley conferences will be webcast live, with links available on the company's website [1]

Financial Data and Key Metrics Changes - The company reported net sales of $23.2 million for Q2 2025, representing a 54% year-over-year growth [13] - Gross margin for Q2 was 53.8%, slightly up from 53.7% in Q2 2024 [15][22] - Total operating expenses increased by 63% to $32.4 million compared to $19.9 million in Q2 2024 [27] Business Line Data and Key Metrics Changes - The company saw 4,934 new patients adopt the Islet, a 57% increase year-over-year [14] - A high twenties percentage of new patient starts were reimbursed through the pharmacy channel, significantly higher than the mid-single digit percentage in Q2 2024 [14][21] - Approximately 71% of new patient starts in Q2 came from individuals using multiple daily injections prior to starting the Islet [21] Market Data and Key Metrics Changes - The company has effective formulary agreements with all major pharmacy benefit managers (PBMs) in the U.S. as of July 1, 2025 [14] - The pharmacy installed base at the end of Q2 2025 was over seven times larger than in Q2 2024 [24] Company Strategy and Development Direction - The company is focused on expanding its pharmacy channel presence to increase access to insulin pump therapy [20] - The company aims to disrupt the industry with its innovation pipeline, including the Mint patch pump and a bihormonal system [44][47] - The company is committed to providing fair and honest representations of its real-world data [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to generate positive free cash flow earlier than peers [28] - The company raised its full-year 2025 guidance for net sales to $88 million to $93 million, up from $82 million to $87 million [30] - Management noted that the recent CMS proposal for the 2026 Durable Medical Equipment Payment System may impact insulin pumps but does not anticipate a material financial impact [39][40] Other Important Information - The company is advancing its innovation pipeline with a target for commercialization of the Mint patch pump by 2027 [46] - The company is exploring the type two diabetes label expansion opportunity, with over 25% of new patient starts in Q2 being type two patients [50] Q&A Session Summary Question: Pricing dynamics in the pharmacy channel - Management noted a downtick in the average selling price (ASP) in the pharmacy channel due to increased adoption from PBMs, which leads to rebates affecting ASP [58] Question: Churn rate specifics - Management did not disclose specific churn rates but emphasized that they monitor retention closely and prioritize sending patients through the pharmacy channel due to its financial advantages [61][62] Question: Drivers of increased guidance - Management expressed confidence in the guidance due to strong Q2 performance and seasonal trends, with Q3 expected to be slightly higher than Q2 [68][70] Question: CMS proposal next steps - Management outlined that CMS will receive comments on the proposal by early September, with a final ruling expected in early November [75] Question: Same store vs. new store dynamics - Management indicated that both increased penetration with existing prescribers and the addition of new prescribers are contributing to growth, but specific quantification was not provided [78] Question: Type two diabetes market dynamics - Management acknowledged off-label prescriptions for type two diabetes and noted that awareness of the Islet is growing among healthcare providers [90] Question: Recurring revenue visibility - Management confirmed that the growing proportion of recurring revenue from the pharmacy channel enhances predictability in revenue guidance [92]

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]