Market Performance - U.S. stocks showed positive movement, with the Nasdaq Composite gaining approximately 150 points on Friday [1] - The Dow increased by 0.38% to 49,453.05, while the NASDAQ rose by 0.66% to 23,635.11, and the S&P 500 climbed 0.48% to 6,954.85 [1] - Utilities sector shares increased by 1.5%, while health care stocks experienced a decline of 0.5% [1] Commodity Prices - Oil prices rose by 2.7% to $59.34, gold increased by 1.2% to $4,514.50, silver surged by 6.3% to $79.895, and copper rose by 2% to $5.9150 [5] European Market Trends - European shares were generally higher, with the eurozone's STOXX 600 gaining 0.91%, Spain's IBEX 35 Index rising 0.01%, London's FTSE 100 increasing by 0.85%, Germany's DAX up by 0.43%, and France's CAC 40 rising by 1.23% [6] Asian Market Trends - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 1.61%, Hong Kong's Hang Seng Index up by 0.32%, China's Shanghai Composite rising by 0.92%, while India's BSE Sensex fell by 0.72% [7] Company-Specific Movements - Rich Sparkle Holdings Ltd saw its shares increase by 115% to $52.00 after signing a $39 million offering of 3 million ordinary shares at $13 per share [9] - Quanterix Corp shares surged by 31% to $8.54 following the appointment of Everett Cunningham as President and CEO [9] - CG Oncology Inc shares rose by 24% to $52.18 after announcing an expedited timeline for clinical trial data [9] - Aquestive Therapeutics Inc shares dropped by 40% to $3.72 due to an FDA letter identifying deficiencies [9] - Pacira Biosciences Inc shares fell by 13% to $22.70 after reporting preliminary FY25 revenue results [9] - Beta Bionics Inc shares decreased by 31% to $21.98 following preliminary fourth-quarter financial results [9] Economic Indicators - Nonfarm payrolls increased by 50,000 in December, slightly below expectations of 60,000 [10] - The unemployment rate decreased from 4.5% in November to 4.4%, below expectations [10] - Average hourly earnings rose by 0.3%, matching forecasts [10] - Housing starts declined by 4.6% to an annualized rate of 1.246 million units, while building permits fell by 0.2% to an annualized rate of 1.412 million [10] - The University of Michigan's consumer sentiment index rose to 54.0 in January, the highest since September 2025 [10]

Core Insights - Beta Bionics Inc. reported strong preliminary fourth-quarter 2025 results with net sales expected to reach at least $32 million, a year-over-year increase of at least 56% compared to the consensus of $28.19 million [1] Group 1: Revenue Growth - Sales through the Durable Medical Equipment (DME) channel are projected to total at least $22.3 million, reflecting an increase of at least 23% [2] - Revenue from the Pharmacy Benefit Plan (PBP) channel is expected to reach at least $9.7 million, significantly up from $2.4 million a year ago [2] Group 2: User Base Expansion - The installed user base is anticipated to exceed 35,000, more than double the 15,298 reported a year earlier [2] - New patient starts for the quarter are projected to be at least 5,581, representing an increase of at least 36% from 4,084 in the fourth quarter of 2024 [2] Group 3: User Demographics - Approximately 69% of new users transitioned from multiple daily insulin injections [3] - A low-30% share of new patient starts were reimbursed through the PBP channel, marking an increase from the prior quarter [3] - Rising adoption among people with Type 2 diabetes accounted for roughly 25% to 30% of new starts [3] Group 4: Financial Guidance - In October 2025, the company raised its fiscal 2025 sales guidance from $88 million-$93 million to more than $96.5 million, compared to the consensus of $91.36 million [4] - The estimated gross margin is now projected at 54% to 55%, up from prior guidance of 52% to 55% [4] Group 5: Analyst Insights - Bank of America downgraded Beta Bionics from Buy to Neutral, citing high valuations and new patient starts coming in 4% below consensus [5] - Analyst Travis Steed noted that with a 1-2% total market share, there should be more momentum in new patient starts, but the market is increasingly competitive [6] - The expected patch pump in 2027 is seen as a long-term catalyst for the stock, but recent updates make it difficult to foresee significant upside until then [6] Group 6: Stock Performance - Beta Bionics shares were down 31.38% at $21.95 at the time of publication [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 8, 2026 N/A (Former name or former address, if changed since last report) Beta Bionics, Inc. 11 Hughes (Exact name of registrant as specified in its charter) Irvine, California 92618 (Address of Principal Executive Offices) (Zip Code) (State or Other Jurisdiction of Incorporation) (949) ...

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].

Summary of Beta Bionics FY Conference Call (December 02, 2025) Company Overview - **Company**: Beta Bionics (NasdaqGM: BBNX) - **Product**: iLet, a diabetes management system utilizing a patch pump Key Industry Insights - **Market Adoption**: The company is experiencing strong adoption of its product, with sales productivity being notable despite a smaller sales force compared to competitors like Tandem [1][2] - **Patient Demographics**: Approximately 70% of patients are transitioning from Multiple Daily Injections (MDI), with over 25% being Type 2 diabetes patients, which is atypical for pump users [7][9] - **Clinical Outcomes**: The iLet system has shown significant clinical outcomes, with a median A1c reduction from 9.7 to 7.5 in patients who are not actively bolusing [13][14] Product Performance - **Ease of Use**: The simplicity and effectiveness of the iLet system resonate well with both patients and clinicians, leading to good outcomes without extensive effort [2][6] - **Market Access Challenges**: A significant portion of clinics remain closed to sales representatives, limiting market access and adoption [3][4] - **Competitive Conversions**: About 30% of new patients are coming from competitive conversions, indicating a strong interest in the iLet algorithm and its effectiveness [15][16] Financial Performance - **Revenue Growth**: The company anticipates adding approximately 19,000 patients in the upcoming year, with a projected revenue increase of around $31 million for 2026 [29][37] - **Pharmacy Channel Success**: There has been notable growth in the pharmacy channel, with nearly doubling the number of patients compared to the previous quarter [21][22] - **Pricing Dynamics**: The company does not foresee significant pricing erosion despite competition, as their pricing model differs from competitors like Tandem [26][27] Product Development and Future Outlook - **Patch Pump Development**: The company is focused on the development of a new patch pump, with expectations for FDA approval in the coming year and a full launch by 2027 [39][46] - **Innovation and Efficiency**: The company emphasizes quick decision-making and a focused approach to product development, which has allowed for rapid progress in bringing new products to market [40][44] - **Market Disruption**: Beta Bionics aims to disrupt the diabetes management market not only through product innovation but also by improving profitability timelines compared to traditional industry standards [54][55] Additional Considerations - **Patient Experience**: The use of a steel cannula is positioned as beneficial for patients, particularly for those with scar tissue, countering common misconceptions about discomfort [48][49] - **Algorithm Efficiency**: The iLet algorithm is highlighted as a key differentiator, providing effective management without the need for frequent manual adjustments [18][53] This summary encapsulates the critical insights and developments discussed during the Beta Bionics FY conference call, highlighting the company's strategic positioning and future growth potential in the diabetes management market.

Summary of Beta Bionics Conference Call Company Overview - **Company**: Beta Bionics (NasdaqGM: BBNX) - **Event**: 2025 Conference on November 18, 2025 Key Points Industry and Market Position - Beta Bionics is experiencing growth in both starts and revenue, with a focus on the insulin pump market [3][4] - The company is competing in a highly competitive environment, particularly against a tubeless pump competitor [7][27] Product Differentiation and Success Factors - The iLet insulin pump has a unique design and algorithm that differentiates it from competitors, leading to commercial success [3][4] - Pharmacy reimbursement has exceeded expectations, generating approximately $450 per month in recurring revenue and facilitating easier prescriptions for doctors [4][5] - The ease of use of the iLet pump is a significant selling point, making it easier for patients to start and maintain their treatment [8][9][12] Clinical Outcomes - The clinical outcomes of the iLet are reported to be as good or better than other systems on the market, with significant improvements in patient A1C levels [9][28] - The company emphasizes the importance of patient lifestyle improvements alongside clinical outcomes, which are often prioritized by users [13] Prescriber Profile and Market Strategy - Ideal prescribers for the iLet are open-minded doctors who prioritize patient outcomes and are willing to adopt new technologies [16][17] - The sales strategy is data-driven, focusing on demonstrating the product's effectiveness through real-time data access for healthcare providers [19] Market Share and Growth Projections - Beta Bionics estimates capturing approximately 11% of new patient starts in the U.S. market, with potential for growth as the sales force expands [23] - The company aims to increase its territories from 63 to around 120 in the long term, with ongoing investments in sales coverage [25] Future Product Development - Beta Bionics is working on a patch pump, targeting commercialization by the end of 2027, with ongoing manufacturing and regulatory preparations [33][40] - The patch pump will be pharmacy-only, leveraging existing pharmacy reimbursement agreements to facilitate market entry [45][47] Regulatory and Compliance Updates - The company is addressing a remediation effort for approximately 34,000 cases, expected to be completed by June 2026 [66] - Ongoing communication with the FDA is in place, with updates provided every 45 days regarding compliance matters [64][66] Conclusion - Beta Bionics is positioned for growth in the insulin pump market, with a focus on product differentiation, ease of use, and strong clinical outcomes. The company is actively preparing for future product launches while managing regulatory compliance effectively.

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cambium Networks Corporation (CMBM) has seen a remarkable increase of 306%, trading at $2.51 [3] - Teradyne, Inc. (TER) is up 21%, currently priced at $176.00 [3] - Bloom Energy Corporation (BE) has risen by 18%, trading at $134.50 [3] - Jamf Holding Corp. (JAMF) is up 15%, with a price of $12.85 [3] - CSG Systems International, Inc. (CSGS) has increased by 14%, trading at $79.00 [3] - Olympic Steel, Inc. (ZEUS) is also up 14%, currently priced at $34.20 [3] - Beta Bionics, Inc. (BBNX) has risen by 12%, trading at $27.20 [3] - Sonim Technologies, Inc. (SONM) is up 10%, currently priced at $12.49 [3] - Canadian Solar Inc. (CSIQ) has increased by 9%, trading at $16.67 [3] - Interlink Electronics, Inc. (LINK) is also up 9%, currently priced at $6.85 [3] Premarket Losers - Stride, Inc. (LRN) has experienced a significant decline of 41%, trading at $89.44 [4] - Varonis Systems, Inc. (VRNS) is down 29%, currently priced at $44.71 [4] - Akebia Therapeutics, Inc. (AKBA) has decreased by 26%, trading at $2.26 [4] - Avantor, Inc. (AVTR) is down 17%, currently priced at $12.40 [4] - GlucoTrack, Inc. (GCTK) has seen a decline of 13%, trading at $6.29 [4] - Tigo Energy, Inc. (TYGO) is down 13%, currently priced at $2.20 [4] - Generac Holdings Inc. (GNRC) has decreased by 9%, trading at $172.00 [4] - Polar Power, Inc. (POLA) is down 8%, currently priced at $3.71 [4] - Caesars Entertainment, Inc. (CZR) has seen a decline of 7%, trading at $20.50 [4] - Anteris Technologies Global Corp. (AVR) is also down 7%, currently priced at $4.46 [4]

Core Insights - Beta Bionics, Inc. (BBNX) reported revenue of $27.25 million for the quarter ended September 2025, showing no change from the same period last year, with an EPS of -$0.33 compared to $0 in the previous year [1] - The revenue exceeded the Zacks Consensus Estimate of $23.92 million by +13.96%, while the EPS surprised positively by +26.67% against the consensus estimate of -$0.45 [1] Revenue Breakdown - Total DME channel revenue was $21.02 million, surpassing the average estimate of $16.22 million from two analysts [4] - Total PBP channel revenue reached $6.24 million, exceeding the average estimate of $5.65 million from two analysts [4] - PBP channel revenue from single-use products was $6.09 million, compared to the average estimate of $5.94 million [4] - DME channel revenue from single-use products was $6.84 million, exceeding the average estimate of $5.48 million [4] - PBP channel revenue from iLet was $0.15 million, below the average estimate of $0.5 million [4] - DME channel revenue from iLet was $14.18 million, surpassing the average estimate of $10.74 million [4] Stock Performance - Beta Bionics, Inc. shares have returned +19.6% over the past month, significantly outperforming the Zacks S&P 500 composite, which changed by +3.6% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Financial Data and Key Metrics Changes - The company reported net sales of $27.3 million for Q3 2025, representing a 63% year-over-year growth [7] - Gross margin improved to 55.5%, up 212 basis points from 53.4% in Q3 2024 and up 167 basis points sequentially from 53.8% in Q2 2025 [10] - Total operating expenses increased to $32.2 million, a 62% rise compared to $19.9 million in Q3 2024 [14] - Cash, cash equivalents, and investments stood at approximately $274 million as of September 30, 2025, indicating sufficient capitalization for key initiatives [15] Business Line Data and Key Metrics Changes - The growth in revenue was driven by 5,334 new patient starts, which grew 68% year-over-year [8] - Approximately 70% of new patient starts in Q3 came from individuals previously using multiple daily injections, indicating market expansion [13] - The percentage of new patient starts reimbursed through the pharmacy channel was in the low 30s, significantly higher than the high single-digit percentage from the previous year [8][9] Market Data and Key Metrics Changes - Over 80% of insured lives in the U.S. are covered under formulary agreements with major pharmacy benefit managers (PBMs) [8] - The company expects 27%-29% of new patient starts to be reimbursed through the pharmacy channel for the full year 2025, an increase from prior guidance [15][16] Company Strategy and Development Direction - The company aims to disrupt the diabetes management industry with innovative products like the iLet and the Mint patch pump [19][20] - The focus remains on driving adoption of the iLet as a pharmacy benefit at the health plan level [9] - The company is committed to expanding its pipeline with new features and products to enhance user experience and clinical outcomes [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business direction, citing strong demand for the iLet and positive real-world outcomes [10][11] - The company raised its full-year 2025 revenue guidance to over $96.5 million, up from previous estimates [15] - Management acknowledged potential variability in pharmacy mix due to seasonal dynamics and ongoing adoption efforts [16] Other Important Information - The company received a special 510(k) clearance for updates to the iLet, improving usability and reducing alert fatigue [23] - A Form 483 was issued by the FDA regarding the company's complaint handling system, but management is confident in their remediation efforts [24][25] Q&A Session Summary Question: What is driving the momentum in revenue growth? - Management indicated that the success is due to the unique positioning of the iLet as a new category of device, with increasing adoption over time [33] Question: Can you elaborate on the patient demographics for new starts? - Approximately one-third of the remaining 30% of new patients are converting from competitive pump systems, with consistent demand patterns observed [39] Question: What is the impact of the FDA Form 483 on operations? - Management stated that they are actively addressing the issues raised and have implemented new systems to ensure compliance [49][50] Question: How does the company view future pharmacy channel growth? - Management expressed uncertainty in predicting specific thresholds for pharmacy channel penetration but aims to maximize the number [92]