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 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]