IRVINE, Calif., Jan. 15, 2026 (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 fourth quarter and full year 2025 financial results after the financial markets close on Tuesday, February 17, 2026. Management will host a conference call and concurrent webcast on the same day at 4:30 pm Eastern Time (1:30 pm Pacific Time), to review the company’s fourth quarter and full year 2025 ...

IRVINE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management solutions, today reported its preliminary, unaudited topline financial results and key metrics for the quarter ended December 31, 2025. Members of the Company’s management team will host in-person meetings in San Francisco, CA from January 12, 2026 through January 14, 2026 to discuss preliminary topline fourth quarter 2025 financial results and key metri ...

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].