Core Viewpoint - Beta Bionics, Inc. plans to pre-release its topline fourth quarter 2025 financial results in early January 2026, highlighting its commitment to transparency and investor engagement [1]. Financial Results - The pre-release will cover key metrics including net sales, new patient starts, and the reimbursement percentage of new patient starts through the pharmacy benefit plan (PBP) channel [2]. Investor Engagement - The management team will hold in-person meetings in San Francisco from January 12 to January 14, 2026, to discuss the topline results, inviting investors to register for these meetings [3]. Company Overview - Beta Bionics is a commercial-stage medical device company focused on developing innovative solutions for insulin-requiring individuals with diabetes, utilizing advanced adaptive closed-loop algorithms [4]. - The iLet Bionic Pancreas is noted as the first FDA-cleared insulin delivery device that autonomously determines insulin doses, aiming to improve health outcomes for a broad population of people with diabetes [4].

Core Insights - Beta Bionics, Inc. reported a significant increase in net sales and raised its full-year guidance for 2025, indicating strong growth in its diabetes management solutions [1][7]. Financial Performance - Net sales reached $27.3 million, a 63% increase from $16.7 million in Q3 2024 [5]. - Durable Medical Equipment (DME) channel net sales were $21.0 million, up 45% from $14.5 million in Q3 2024 [5]. - Pharmacy Benefit Plan (PBP) channel net sales surged 178% to $6.2 million from $2.2 million in Q3 2024 [5]. - Gross margin improved to 55.5%, up 212 basis points from 53.4% in Q3 2024 [5]. - The installed customer base grew to 29,419 users, a 162% increase from 11,214 in Q3 2024 [5]. - New patient starts totaled 5,334, a 68% increase from 3,180 in Q3 2024 [5]. - The company reported a loss from operations of $17.0 million, or negative 63% of sales, compared to a loss of $11.0 million or negative 66% of sales in Q3 2024 [5]. Strategic Developments - As of July 1, 2025, Beta Bionics has effective formulary agreements with all major pharmacy benefit managers in the U.S. [5]. - The completion of a glucagon pharmacokinetic-pharmacodynamic trial in Canada supports the development of the glucagon asset for the bihormonal system [5]. - A feasibility trial in New Zealand is expected to be initiated in Q4 2025 to test the bihormonal system in humans [5]. Full Year Guidance - The company estimates total revenue exceeding $96.5 million, up from a previous estimate of $88 million to $93 million [12]. - The expected percentage of new patient starts reimbursed through the PBP channel is revised to 27% to 29%, up from 25% to 28% [12]. - Estimated gross margin is now projected at 54% to 55%, an increase from the previous estimate of 52% to 55% [12].

Core Insights - Beta Bionics, Inc. plans to release its third quarter 2025 financial results on October 28, 2025, after market close [1] - A conference call and webcast will be held on the same day at 4:30 pm Eastern Time [1] Company Overview - Beta Bionics 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 [2] - The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device that autonomously determines insulin doses, aiming to improve health outcomes for a wide range of diabetes patients [2]

Company Overview - InspireMD, Inc. is a developer of the CGuard® Prime carotid stent system aimed at preventing strokes [1] - The company is publicly traded on Nasdaq under the ticker symbol NSPR [5] Leadership Appointment - Dan Dearen has been appointed to the Board of Directors, bringing nearly 40 years of experience in the medical device and life sciences sectors [1][2] - His previous roles include President, co-Founder, and Chief Financial Officer of Axonics, Inc., which was acquired by Boston Scientific for $3.7 billion in November 2024 [2][3] Strategic Importance - The appointment of Mr. Dearen is seen as timely as InspireMD continues its U.S. commercial launch of the CGuard Prime stent system [2] - The company aims to lead the carotid intervention market and execute its long-term value-creation strategy [2] Market Potential - Mr. Dearen expressed optimism about InspireMD's potential to change the standard of care in vascular medicine and improve patient outcomes [2] - The company utilizes proprietary MicroNet™ mesh technology to enhance the effectiveness of its carotid stenting products [5]

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]

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]

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].

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]

Core Insights - Beta Bionics, Inc. reported a strong financial performance for Q1 2025, with net sales reaching $17.6 million, a 36% increase from $12.9 million in Q1 2024, and raised its annual guidance for 2025 [1][6][12] Financial Results - Net sales of $17.6 million, up 36% compared to $12.9 million in Q1 2024 [6] - Durable Medical Equipment (DME) channel net sales of $13.8 million, up 14% from $12.1 million in Q1 2024 [6] - Pharmacy Benefit Plan (PBP) channel net sales of $3.8 million, up 360% from $0.8 million in Q1 2024 [6] - Gross margin of 50.9%, down 482 basis points from 55.7% in Q1 2024 [6] - Loss from operations of $18.6 million, or negative 106% of sales, compared to $9.5 million or negative 73% of sales in Q1 2024 [6] - Net loss of $28.7 million, or negative 162% of sales, compared to $12.4 million or negative 96% of sales in Q1 2024 [6] - Adjusted EBITDA of negative $15.5 million, or negative 88% of sales, compared to negative $7.8 million or negative 60% of sales in Q1 2024 [6] Customer Metrics - Installed customer base of 19,151 users, up 291% from 4,901 in Q1 2024 [6] - 3,853 new patient starts, up 48% from 2,597 in Q1 2024 [6] - 71% of new patient starts came from multiple daily injections (MDI) [6] - Low 20s percentage of new patient starts reimbursed through the PBP channel [6] Strategic Developments - Completed an upsized initial public offering and private placement on January 31, 2025, raising approximately $206 million in net proceeds [6] - Prime Therapeutics added the iLet Bionic Pancreas to its largest national commercial formulary, which is expected to ease costs for patients and administrative burdens for physicians [6] - Initiated enrollment for a glucagon pharmacokinetic-pharmacodynamic bridging trial in Canada [6] - An investor event is scheduled for June 22, 2025, to provide updates on commercial and financial performance [6]