Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Chijet Motor Company, Inc. (CJET) is up 40% at $2.67 - JX Luxventure Group Inc. (JXG) is up 19% at $4.12 - Inspire Medical Systems, Inc. (INSP) is up 15% at $103.50 - Epsium Enterprise Limited (EPSM) is up 15% at $4.14 - Oscar Health, Inc. (OSCR) is up 12% at $15.13 - Green Dot Corporation (GDOT) is up 11% at $13.21 - Butterfly Network, Inc. (BFLY) is up 6% at $2.82 - Cullinan Therapeutics, Inc. (CGEM) is up 5% at $10.00 - Vir Biotechnology, Inc. (VIR) is up 5% at $5.99 - Nvni Group Limited (NVNI) is up 5% at $3.17 [3] Premarket Losers - Clearside Biomedical, Inc. (CLSD) is down 69% at $0.82 - Twin Hospitality Group Inc. (TWNP) is down 20% at $2.84 - Shuttle Pharmaceuticals Holdings, Inc. (SHPH) is down 15% at $1.35 - Mobile-Network Solutions (MNDR) is down 12% at $4.16 - Waldencast plc (WALD) is down 10% at $2.75 - authID Inc. (AUID) is down 9% at $1.21 - EZGO Technologies Ltd. (EZGO) is down 6% at $1.98 - SciSparc Ltd. (SPRC) is down 5% at $2.34 - Twin Vee Powercats Co. (VEEE) is down 5% at $1.70 - Agape ATP Corporation (ATPC) is down 5% at $1.22 [4]

Core Insights - Biotech and healthcare stocks experienced significant movements in after-hours trading, driven by corporate updates and investor anticipation [1] Company Updates - Butterfly Network, Inc. (BFLY) shares increased by 6.04% to $2.81 after a 14.22% rise to $2.65 at market close, following the announcement of CEO Joseph DeVivo and Interim CFO Megan Carlson's participation in the 8th Annual Evercore Healthcare Conference [2] - Citius Pharmaceuticals Inc. (CTXR) saw a 7.90% increase to $1.23 after a 15.15% rally to $1.14, attributed to a deeper collaboration with Verix for the commercialization of LYMPHIR, an FDA-approved immunotherapy expected to launch in Q4 2025 [3] - ProQR Therapeutics N.V. (PRQR) rose 6.80% to $2.20 after a flat close at $2.06, with no specific news indicating that the movement may be due to investor sentiment [4] - Perrigo Company plc (PRGO) advanced 3.97% to $13.14, building on a 3.10% gain at the close, reflecting steady investor interest despite no new announcements [4] - Tempest Therapeutics, Inc. (TPST) added 4.86% to $3.67 after reversing a decline, following the announcement of plans to acquire CAR-T programs from Factor Bioscience, expected to close in early 2026 [5] - Iterum Therapeutics plc (ITRM) rose 2.77% to $0.3969 after a 4.38% gain at the close, with no new updates released [6] - Processa Pharmaceuticals, Inc. (PCSA) edged up 1.86% to $0.26 despite a steep decline at the close, with no news issued [6]

Core Insights - Butterfly Network, Inc. is participating in the 8th Annual Evercore Healthcare Conference, with key executives scheduled for a fireside chat and one-on-one investor meetings [1][2] - The company is recognized for its innovative Ultrasound-on-Chip™ technology and has launched several handheld ultrasound systems, including the award-winning iQ3 [3][4] Company Overview - Butterfly Network, Inc. is a digital health company focused on transforming medical imaging through handheld, whole-body ultrasound technology and intuitive software solutions [1][3] - The company launched the first handheld, single-probe, whole-body ultrasound system, Butterfly iQ, in 2018, followed by the iQ+ in 2020 and the iQ3 in 2024, each improving in processing power and performance [3] - The iQ3 received the Best Medical Technology award at the 2024 Prix Galien USA Awards, highlighting its significance in the healthcare sector [3] Product and Technology - Butterfly combines advanced hardware, intelligent software, AI, services, and education to enhance the adoption of affordable and accessible imaging solutions [4] - The company’s handheld ultrasound probes, paired with Compass™ enterprise workflow software, have been shown to improve care workflows, reduce costs, and enhance provider economics [4] - Butterfly's devices are available to trained healthcare practitioners globally, addressing critical healthcare challenges [4]

Core Insights - Butterfly Network Inc. has launched Compass AI, an AI-powered operating system aimed at enhancing point-of-care ultrasound (POCUS) programs for health systems, focusing on compliance, scalability, and revenue generation [1][3] Group 1: Product Launch and Features - Compass AI replaces traditional, order-based POCUS workflows, which often result in documentation delays and unbilled exams, capturing only about 15% of compliant studies [2] - The new AI-enhanced, encounter-based workflow can achieve documentation compliance rates of up to 94% without increasing the workload for clinicians [3] Group 2: Financial Implications - The transformation brought by Compass AI can potentially lead to up to 5 times more revenue from the same clinical volume by capturing previously missed value [3] Group 3: Company Overview - Butterfly Network Inc. develops, manufactures, and commercializes ultrasound imaging solutions both in the US and internationally [4]

Core Insights - Butterfly Network, Inc. (BFLY) has launched Compass AI, a next-generation enterprise software platform aimed at enhancing point-of-care ultrasound (POCUS) programs across health systems, which is expected to significantly improve documentation compliance and revenue generation from existing exam volumes [1][8]. Short-term Outlook - Compass AI is positioned to capitalize on increased enterprise demand as health systems seek rapid, revenue-boosting solutions, addressing long-standing workflow and compliance issues that could lead to accelerated adoption and enhanced software monetization [2][4]. Stock Performance - Following the announcement of Compass AI, BFLY's shares experienced a decline of nearly 7% at the previous day's close. However, year-to-date, the shares have increased by 34.7%, outperforming the industry, which saw a decline of 10.8%, while the S&P 500 rose by 12.2% during the same period [3]. Long-term Strategy - In the long run, Compass AI is expected to solidify BFLY's role as a core infrastructure partner for health systems, transitioning the company towards a more sustainable, software-driven revenue model. This deeper integration into POCUS workflows is anticipated to enhance customer retention, facilitate multi-department deployments, and promote steady growth in recurring revenue [4][12]. Product Features - Compass AI addresses significant workflow and documentation challenges in POCUS programs, with traditional workflows capturing only about 15% of compliant studies, leaving 85% unbilled. The new platform aims to achieve documentation compliance rates of up to 94% without increasing clinician workload, potentially allowing health systems to generate up to five times more revenue from the same clinical load [9][10]. - The platform includes a Documentation Agent that utilizes ambient voice dictation to automate exam note completion, reducing charting time by up to 25%. Additionally, the QA Agent enhances quality review through AI-based image evaluation and feedback [10]. - Compass AI features a Program Dashboard that monitors usage, documentation compliance, credentialing, and unbilled studies, providing insights into operational performance and potential return on investment (ROI). It also integrates seamlessly with electronic health records (EHRs), PACS, and SSO systems, ensuring efficient routing of studies into medical records and preventing lost images [11][12].

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Core Insights - Butterfly Network, Inc. (BFLY) reported a third-quarter 2025 loss of $0.13 per share, which was wider than the Zacks Consensus Estimate of a loss of $0.07 per share, and compared to a loss of $0.08 per share in the same period last year [1][9] - Revenues for the third quarter reached $21.5 million, reflecting a year-over-year increase of 4.5% and exceeding the Zacks Consensus Estimate by 2.4% [1][9] Revenue Performance - International revenues increased by 4% year over year to $5.4 million, attributed to the higher price point of the iQ3 probe launched internationally in Q3 2024 [2] - The overall revenue growth indicates a positive trend despite the wider loss reported [6] Margin Performance - The company's gross loss for the third quarter was $3.8 million, a significant decline from a gross profit of $12.2 million in the same quarter last year, primarily due to a 203.2% increase in the cost of revenues [3] Expense Analysis - Selling and marketing expenses rose by 10.6% year over year to $10.6 million, while research and development expenses decreased by 1.6% to $8.7 million. General and administrative expenses saw a slight drop of 0.7% to $9 million [4] - The operating loss for the quarter was $32.3 million, compared to a loss of $15.6 million in the same period of 2024 [4] Future Guidance - For 2025, the company anticipates revenues between $91 million and $95 million, indicating approximately 13% growth, with the Zacks Consensus Estimate currently at $91 million [5] - The adjusted EBITDA loss is expected to be between $32 million and $35 million, a slight adjustment from the previous estimate of $32 million to $37 million [5] Innovations and Developments - Recent innovations include the launch of an AI-powered Gestational Age Calculator in Malawi and Uganda, which is pending FDA review [6] - The HeartFocus by DESKi app became the first FDA-cleared third-party app on Butterfly Garden, enabling AI-guided echo exams [7] - The company has completed the development of the P5.1 chip and initiated the development of the sixth-generation Apollo AI chip for enhanced edge AI capabilities [7]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $21.5 million, reflecting a 5% growth over the prior year, driven by higher average selling prices and increased volume, particularly in the U.S. [14][15] - Gross margin, including a non-cash inventory write-off of $17.4 million, was negative 17.5%, compared to 59.5% in the prior year. Adjusted gross margin increased to 63.9% from 60% in the prior year [17][18] - Adjusted EBITDA loss was $8.1 million, an improvement from a loss of $8.4 million in Q3 2024, leading to a normalized cash burn of $3.9 million [18][19] - Cash and cash equivalents at the end of the quarter were $148 million, with a trailing 12-month cash use of $31.5 million [19] Business Line Data and Key Metrics Changes - Product revenue was $14.6 million, an increase of 8% versus Q3 2024, driven by higher average selling prices in international markets and increased volume in e-commerce and veterinary channels [15][16] - Software and other services revenue was $6.9 million, flat compared to the prior year, with increased licensing and services revenue offset by lower renewals of individual subscriptions [16] Market Data and Key Metrics Changes - Total international revenue increased 4% over the prior year to $5.4 million, primarily driven by price increases following the international launch of iQ3 [15] - U.S. revenue was $16.1 million, slightly up from the previous year, attributed to e-commerce sales and improved performance in the veterinary distribution channel [15] Company Strategy and Development Direction - The company is focusing on enterprise sales by building a strategy that integrates Butterfly more holistically within health systems, despite facing headwinds in the second quarter [5][6] - The five-year plan introduced multiple growth pillars, including deeper engagement in core business areas and expansion into new markets [5][6] - The AI strategy is seen as a significant accelerator, with successful trials demonstrating the economic impact of Butterfly's AI tools on patient care and hospital efficiency [8][12] Management's Comments on Operating Environment and Future Outlook - Management noted that while Q3 is typically the quietest quarter, they are optimistic about returning to momentum in 2026, with increased pipeline opportunities [5][21] - The company reaffirmed its full-year revenue guidance of $91 to $95 million, indicating a need to close larger deals in the pipeline to reach the higher end of the range [22][23] - Management expressed confidence in the long-term positioning of Butterfly Network, emphasizing the affordability and flexibility of their technology compared to traditional ultrasound solutions [24] Other Important Information - The company has strengthened its information security posture with new certifications, enhancing its competitive advantage in the market [7][56] - The P5.1 chip development has been completed, expected to significantly enhance imaging capabilities and performance, with production set to begin [26][27] Q&A Session Summary Question: Can you quantify the size of some deals that have been pushed due to macro factors? - Management indicated that deals can range from 100 to 200 probes, with large medical school deals also in the pipeline [33][35] Question: What is the outlook for the sales pipeline heading into 2026? - Management noted that while the time to close has extended, there are more deals stacking up, and they expect a lift in 2026 as budgets reset [41][42] Question: How will the cost-effectiveness data from the Rutgers study impact future sales? - The study establishes significant economic benefits, which will strengthen the company's position in enterprise sales discussions [43][46] Question: What is the status of the HomeCare program? - Management remains optimistic about the channel but emphasized that until agreements are finalized, nothing is certain [47] Question: What is needed to de-risk the launch of the P5.1 chip? - Management expressed confidence in the low risk of execution for the new product launch, citing successful past launches as a precedent [50][52] Question: How does the new information security certification help win business? - The company believes its cloud connectivity and security posture provide a competitive advantage, especially as the industry shifts towards cloud solutions [56][57]

Revenue and Sales Performance - Units fulfilled increased by 221 units, or 4.7%, for the three months ended September 30, 2025 compared to the same period in 2024, driven by higher probe sales volume in US sales channels [89]. - Total revenue for the three months ended September 30, 2025 was $21.5 million, a 4.5% increase from $20.6 million in the same period of 2024, with product revenue increasing by $1.0 million, or 7.5% [104]. - Product revenue increased by $5.9 million, or 14.9%, for the nine months ended September 30, 2025, driven by semiconductor chip deliveries and higher average selling prices in international markets [114]. Expenses and Profitability - Cost of product revenue increased by $17.5 million, or 288.3%, for the three months ended September 30, 2025, primarily due to a non-recurring charge for excess and obsolete inventory [107]. - Gross profit for the three months ended September 30, 2025 was a loss of $3.8 million, compared to a profit of $12.2 million in the same period of 2024 [103]. - Research and development expenses for the three months ended September 30, 2025 were $8.7 million, representing 40.5% of total revenue [103]. - Total operating expenses for the three months ended September 30, 2025 were $31.4 million, or 146.0% of total revenue [103]. - Net loss for the three months ended September 30, 2025 was $34.0 million, compared to a net loss of $16.9 million in the same period of 2024 [103]. - Research and development expenses decreased by $2.0 million, or 7.0%, for the nine months ended September 30, 2025, primarily due to a reduction in personnel costs [119]. - Sales and marketing expenses increased by $4.1 million, or 13.8%, for the nine months ended September 30, 2025, driven by higher personnel and employment-related costs [120]. - General and administrative expenses decreased by $1.9 million, or 6.2%, for the nine months ended September 30, 2025, primarily due to reductions in insurance and personnel costs [121]. - Other expenses increased by $1.8 million, or 49.8%, for the nine months ended September 30, 2025, driven by higher legal costs due to litigation [122]. Cash Flow and Liquidity - The company reduced its annual cash requirements by approximately $180 million, to less than $50 million annually [85]. - Net cash used in operating activities decreased by $16.9 million, or 43.7%, for the nine months ended September 30, 2025, due to improvements in net loss and working capital cash usage [130]. - Net cash provided by financing activities increased by $79.5 million for the nine months ended September 30, 2025, primarily from the net proceeds of an $81.0 million public share offering [132]. - As of September 30, 2025, the company had cash and cash equivalents of $144.2 million, with expectations that existing cash will meet liquidity and capital expenditure needs for at least the next 12 months [124]. - The company raised $81.0 million through the issuance of 27.6 million shares of Class A common stock on January 31, 2025 [124]. Inventory and Charges - As of September 30, 2025, the company recognized an additional $17.4 million non-recurring charge for excess and obsolete inventory due to technological advancements and changes in the product portfolio [134]. - Cost of revenue as a percentage of revenue increased from 41.2% to 62.9% for the nine months ended September 30, 2025, primarily due to a $17.4 million excess and obsolete inventory charge [118]. Market and Economic Conditions - The company does not expect cash flows to be significantly affected by a sudden change in market interest rates, including an immediate change of 100 basis points [137]. - Inflation has not had a material effect on the company's business, but rising costs due to inflationary pressures may not be fully offset by price increases [138]. - The company operates primarily in the U.S. and executes most transactions in U.S. dollars, with limited foreign currency translation risk [139]. Accounting Policies - There have been no material changes to the critical accounting policies and estimates disclosed in the 2024 Annual Report [135]. - The company did not identify any significant recently issued accounting pronouncements that may impact its financial position [136].

Revenue Performance - Total revenue for Q3 2025 was $21.5 million, representing a 5% increase from $20.6 million in Q3 2024[4] - U.S. revenue was $16.1 million, while international revenue increased by 4% year-over-year to $5.4 million[4] - Total revenue for Q3 2025 was $21.489 million, a 4.5% increase from $20.561 million in Q3 2024[25] - Product revenue increased to $14.556 million in Q3 2025, up 7.5% from $13.538 million in Q3 2024[25] - The company reaffirmed its full-year revenue guidance of $91 million to $95 million, indicating approximately 13% growth[16] Profitability and Loss - Gross loss was $3.8 million, compared to a gross profit of $12.2 million in the prior year period, with total GAAP gross margin at (17.5)%[5] - Adjusted gross profit was $13.7 million, with adjusted gross margin increasing to 63.9% from 60.0% in the prior year[5] - Gross loss for Q3 2025 was $(3.757) million, compared to a gross profit of $12.233 million in Q3 2024, resulting in a gross margin of (17.5%) versus 59.5%[31] - Net loss for the quarter was $34.0 million, compared to $16.9 million in the prior year[9] - Net loss for Q3 2025 was $(33.971) million, compared to a net loss of $(16.924) million in Q3 2024, resulting in a net loss per share of $(0.13) versus $(0.08)[25] - Adjusted net loss for the nine months ended September 30, 2025, was $26.171 million, an improvement from a loss of $34.552 million in 2024[33] - Adjusted EBITDA loss was $8.1 million, an improvement from $8.4 million in the prior year[10] - Adjusted EBITDA for the three months ended September 30, 2025, was $(8.079) million, compared to $(8.445) million in 2024[33] Operating Expenses - Operating expenses were $31.4 million, up 6% from $29.5 million in the prior year[8] - Operating expenses rose to $31.377 million in Q3 2025, up from $29.479 million in Q3 2024, with R&D expenses at $8.703 million[25] - Stock-based compensation increased to $4.925 million in Q3 2025 from $4.411 million in Q3 2024[33] Cash and Assets - Cash and cash equivalents stood at $144.2 million as of September 30, 2025[12] - Cash and cash equivalents increased to $144.233 million as of September 30, 2025, compared to $88.775 million at December 31, 2024[27] - Total assets as of September 30, 2025, were $290.002 million, up from $256.082 million at December 31, 2024[27] Inventory and Write-downs - The company reported a write-down of inventories of $7.931 million for the nine months ended September 30, 2025[29] - Write-downs and write-offs of inventories and vendor advances were $17.486 million in Q3 2025, significantly higher than $97,000 in Q3 2024[33] Other Financial Metrics - Interest income for the nine months ended September 30, 2025, was $4.598 million, up from $4.023 million in 2024[33] - Depreciation and amortization expenses for the nine months ended September 30, 2025, were $6.327 million, down from $7.835 million in 2024[33] - Other income (expense), net for the nine months ended September 30, 2025, was $(2.824) million, compared to $(517,000) in 2024[33] Product Development - New product developments include the P5.1 chip moving to production and the Apollo AI chip initiating development[2]